Prospective, Multicentre Clinical Trial Measuring the Impact of Treatment With ALVEOGYL in Patients With Post-extraction Dry Socket
Conditions: Dry Socket
Sponsor: Septodont

Short Title: Al VE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
Clinical Investigation Plan 
Study medical device: Alveogyl 
Short title: ALVE study 
Full study title: Prospective, multicentre clinical trial measuring the impact of treatment with ALVEOGYL in patients 
with post-extraction dry socket 
VERSION AND DATE OF THE CIP: Version 3 - 22/01/2025 
SPONSOR CIP NUMBER: ALVE 2022-01 
FRANCE: 
ID RCB number: 2022-A00208-35 
Regulatory situation: Observational study registered as "other investigation Case 1 Clinical Investigation PMCF" 
INDIA: 
Study number registration: CI/MD/2022/66273 
Regulatory situation: Pivotal clinical study 
SPONSOR: 
SEPTODONT 
127 Boulevard Diderot 
75012 Paris 
France 
E-mail:-
Sponsor's representative: 
Farid BENABDALLAH 
CON Fl DENTIAL 
INTERNATIONAL COORDINATING INVESTIGATOR: 
Pr. Geraldine LESCAILLE 
75013 Paris 
France 
E-mail: 
Phone: 
CIP Version 3- 22 January 2025 
CRO FOR STUDY MANAGEMENT IN INDIA: 
SMO Clinical Research Pvt Ltd 
India 
E-mail: 
Phone: 
Contact: Dr. K H Ramanjaneya 
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Short Title: ALVE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
REVISION HISTORY 
CIP version 
Date 
Summary of revisions 
; Version 1.0 
08 March 2022 
Initial version 
i ...... 
. ............................................. 
Version 1.1 
06 May 2022 
Modifications brought upon comments from the French 
Ethics Committee (session of 19/04/2022): eligibility 
criteria, study duration, and risks were modified. 
Version 2 
04 December 2023 
Modifications to extend recruitment period . 
Version 3 
22 January 2025 
Modifications to extend recruitment period . 
CONFIDENTIAL 
CIP Version 3 - 22 January 2025 
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Short Title: ALVE 
Sponsor Code: 2022-A00208-35 
SIGNATURES PAGE 
STUDY REGISTRATION ID: 
STU DY TITLE: 
Sponsor: SEPTODONT 
2022-A00208-35 (ID RCB in France) - CI/MD/2022/66273 (India) 
Prospective, multicentre clinical trial measuring the impact of treatment 
with ALVEOGYL in patients with post-extraction dry socket 
The Sponsor, the international study coordinating investigator and the Statistician have approved the 
Cl P version (Version 3 - 22/01/2025), and confirm hereby to conduct the investigation according to the 
CIP (and are not allowed to deviate from it), the current version of the World Medical Association 
Declaration of Helsinki, ISO 14155:2020 norm, ICH-GCP as far as applicable, and the loca l legally 
applicable requirements. 
Sponsor Representative: 
Farid BENABDALLAH 
International Study Coordinating 
Investigator: 
! Pr. Geraldine LESCAILLE 
! 
Date 
Signature 
-----·-···-··-.. ···-.. -.. _ ...... _ .. _.,_.,_., 
! .. ---------------+-- -------+-----------------< 
Statistician: 
Alexia LETI ERCE 
CONFIDENTIAL 
CIP Version 3 - 22 January 2025 
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Short Title: ALVE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
TABLE OF CONTENTS 
REVISION HISTORY ........................................................................................................................................... 2 
SIGNATURES PAGE ........................................................................................................................................... 3 
LIST OF TABLES ................................................................................................................................................. 7 
LIST OF FIGURES ............................................................................................................................................... 7 
LIST OF ABBREVIATIONS ................................................................................................................................... 8 
PROTOCOL SUMMARY ..................................................................................................................................... 9 
1 
BACKGROUND AND RATIONALE ............................................................................................................ 13 
1.1 
BACKGROUND AND RATIONALE FOR THE CLIN ICAL INVESTIGATION ....................................................................... 13 
1.2 
CLIN ICAL EVIDENCE TO DATE ....................................................................................................................... 13 
1.3 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION ........................................................................ 14 
1.4 
JUSTIFICATION OF THE CHOICE OF THE INVESTIGATION POPULATION .................................................................... 14 
1.5 
RISK EVALUATION (RISK-TO-BENEFITS RATIONALE) ........................................................................................... 14 
1.5.1 
Anticipated clinical benefits ............................................................................................................ 14 
1.5.2 
Anticipated adverse events related to device or procedure ........................................................... 14 
1.5.3 
Risks associated with participation in the clinical investigation ..................................................... 15 
1.5.4 
Possible interaction with concomitant medical treatments as considered under the risk analysis 15 
1.5.5 
Steps that will be taken to control or mitigate the risks ................................................................. 15 
1.5.6 
Rationale for benefit-risk ratio ........................................................................................................ 15 
2 
DESCRIPTION OF THE STUDY DEVICE ...................................................................................................... 16 
2.1 
STUDY DEVICE .......................................................................................................................................... 16 
2.1.1 
Description ...................................................................................................................................... 16 
2.1.2 
Intended purpose ............................................................................................................................ 17 
2.1.3 
Indications ....................................................................................................................................... 17 
2.1.4 
Patient population ........................................................................................................................... 17 
2.1.5 
Users ................................................................................................................................................ 17 
2.1.6 
Experience/ Training needed ......................................................................................................... 17 
2.2 
MANUFACTURER ...................................................................................................................................... 17 
3 
STUDY OBJECTIVES AND ENDPOINTS ..................................................................................................... 18 
3.1 
STUDY OBJECTIVES .................................................................................................................................... 18 
3.1.1 
Primary objective ............................................................................................................................ 18 
3.1.2 
Secondary objectives ....................................................................................................................... 18 
3.2 
STUDY ENDPOINTS .................................................................................................................................... 18 
3.2.1 
Primary endpoint ............................................................................................................................ 18 
3.2.2 
Secondary endpoints ....................................................................................................................... 18 
4 
INVESTIGATIONAL PLAN ........................................................................................................................ 18 
4.1 
STUDY DESIGN .......................................................................................................................................... 18 
4.2 
STUDY DURATION, ENROLMENT AND SITES ............ ............. . ....... ....... .... ........... .................................... .......... 19 
4.2.1 
Duration of enrolment .................................................................................................................... 19 
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Short Title: ALVE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
4.2.2 
Duration of study participation ....................................................................................................... 19 
4.2.3 
Number of investigational sites and patients estimated ................................................................ 19 
4.3 
STUDY POPULATION .................................................................................................................................. 19 
4.3.1 
Inclusion criteria .............................................................................................................................. 19 
4.3.2 
Exclusion criteria ............................................................................................................................. 19 
4.4 
PATIENT INFORMATION AND INFORMED CONSENT ........................................................................................... 20 
4.4.1 
Minors/underage patients .............................................................................................................. 20 
4.4.2 
Other vulnerable subjects ............................................................................................................... 20 
4.5 
STUDY PROCEDURES ................................................................................................................................. 21 
4.5.1 
Visit 1- Day 0 .................................................................................................................................. 21 
4.5.2 
Follow-up visit (Visit 2 - Day 7) ....................................................................................................... 21 
4.5.3 
Unscheduled visits ........................................................................................................................... 22 
4.5.4 
Patient completion/Withdrawal ..................................................................................................... 22 
4.6 
STUDY EARLY TERMINATION ........................................................................................................................ 22 
5 
STATISTICAL METHODS .......................................................................................................................... 23 
5.1 
HYPOTHESIS ............................................................................................................................................ 23 
5.2 
DETERMINATION OF SAMPLE SIZE ................................................................................................................. 23 
5.3 
STATISTICAL CRITERIA OF TERMINATION OF THE STUDY ..................................................................................... 23 
5.4 
STATISTICAL METHODS FOR PLANNED ANALYSES ............................................................................................. 23 
5.4.1 
Analysis populations ........................................................................................................................ 24 
5.4.2 
Baseline Data ................................................................................................................................... 24 
5.4.3 
Analysis of Primary endpoint .......................................................................................................... 24 
5.4.4 
Analysis of Secondary endpoints ..................................................................................................... 24 
5.4.5 
Interim analyses .............................................................................................................................. 24 
5.4.6 
Deviation(s) from the original statistical plan ................................................................................. 24 
5.5 
HANDLING OF MISSING DATA AND DROP-OUTS ............................................................................................... 24 
6 
SAFETY MANAGEMENT .......................................................................................................................... 25 
6.1 
DEFINITIONS ............................................................................................................................................ 25 
6.2 
SAFETY DATA RECORDING ........................................................................................................................... 27 
6.3 
SAFETY DATA REPORTING ........................................................................................................................... 27 
6.3.1 
Reporting to the Sponsor ................................................................................................................ 27 
6.3.2 
Reporting to Ethic Committee and Competent/Regulatory Authority ........................................... 28 
6.4 
ADVERSE EVENTS CATEGORIZATION .............................................................................................................. 29 
6.5 
EMERGENCY CONTACT ............................................................................................................................... 29 
6.6 
DATA MONITORING COMMITTEE ................................................................................................................. 29 
7 
ETHICAL AND REGULATORY ASPECTS ..................................................................................................... 29 
7 .1 
REGISTRATION OF THE STU DY ...................................................................................................................... 30 
7 .2 
STUDY APPROVAL ............................................................................................................ ......................... 30 
7.2.1 
Ethics Committee (EC/IRB) .............................................................................................................. 30 
7.2.2 
Competent/regulatory authorities (CA/RA) ...................................................................... .............. 30 
7 .3 
COMPLIANCE STATEMENT ........................................................................................................................... 30 
8 
STUDY DEVICE ACCOUNTABILITY ........................................................................................................... 30 
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Short Tit le: ALVE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
8.1 
LABELLING ...................... ............................................. ........... . ... ...... ......... ............ .. ....... ......... ................ 30 
8.2 
STORAGE CONDITIONS .......... .. ................. ......... ............. ............... ............... ............ ... ...... ...... .. ....... .......... 31 
8.3 
SUPPLY (AND RE-SUPPLY) ........................................................................................................................... 31 
8.4 
RETURN, ANALYSIS OR DESTRUCTION OF THE STUDY DEVICE ............................................................................... 31 
9 
QUALITY ASSURANCE AND CONTROL .................................................................................................... 31 
9.1 
DATA HANDLING AND RECORD KEEPING ......................................................................................................... 31 
9.1.1 
Case report forms ............................................................................................................................ 31 
9.1.2 
Specification of source data and source documents ...................................................................... 31 
9.1.3 
Record keeping of essential clinical investigation documents ........................................................ 32 
9.2 
DATA MANAGEMENT ................................................................................................................................. 32 
9.2.1 
Data management system .............................................................................................................. 32 
9.2.2 
Data security, access and back-up ........................... ........................................................................ 32 
9.2.3 
Electronic and central data validation ................................................................ ............... .............. 33 
9.2.4 
Archiving .................................................................. ................. ....................................................... 33 
9.3 
MONITORING ..................... ......................................... ..................... ......... ............. ................................. 33 
9.4 
AUDITS AND INSPECTIONS .......................................................................................................................... 33 
9.5 
SUBJECT PRIVACY, CONFIDENTIALITY, DATA PROTECTION ................................................................................... 34 
9.6 
STORAGE OF BIOLOGICAL MATERIAL AND RELATED HEALTH DATA ........................................................................ 34 
10 
PUBLICATION AND DISSEMINATION POLICY .......................................................................................... 34 
11 
FUNDING AND SUPPORT ........................................................................................................................ 35 
11.1 
FUNDING ................................................................................................................................................ 35 
11.2 
OTHER SUPPORT ............ .... ........................................... ..................... ......... ............. ................................. 35 
12 
INSURANCE ............................................................................................................................................ 35 
13 
MEDICAL TREATMENT/ COMPENSATION OF THE PATIENT .................................................................... 35 
14 
REFERENCES ........................................................................................................................................... 36 
APPENDICES ................................................................................................................................................... 37 
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Short Title: ALVE 
Sponsor Code: 2022-A00208-35 
LIST OF TABLES 
Table 1: Schedule of Study Procedures 
Table 2: Composition of Alveogyl 
LIST OF FIGURES 
Figure 1: Primary and secondary packaging of Alveogyl 
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Sponsor: SEPTODONT 
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Short Title: ALVE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
LIST OF ABBREVIATIONS 
ABBREVIATION 
SIGNIFICATION 
ADE 
Adverse Device Effect 
>-----·-··-.. ·-····---
AE 
Adverse Event 
___ 
,. ................................................ " ....... ... 
ASR 
Annual Safety Report 
>-----·-.. -... -.. ·---
.. _ ... _ .. _ .. _ .. _. ·-....... -.... _ .. _._ .... __________ 
_ 
CA/RA 
Competent Authority/ Regulatory Authority 
COSCO 
Central Drugs Standard Control Organisation 
___ , .. _ ... _ .. _ .. _ .. _. ·-....... -.... _ .. _._ .... __________ _ 
CIP 
Clinical Investigation Plan 
CRA 
Clinical Research Associates 
!------·-.. -... -.. ·---
.. _ ... _ .. _ .. _ .. _. ·-....... -.... _ .. _._ .... __________ 
_ 
CRF 
Case Report Form 
CRO 
Contract Research Organisation 
CTA 
Clinical Trial Agreement 
Device Deficiency 
DD 
EC /IRB 
Independent Competent Ethic Committee/ Independent Institutional Review 
Board 
e-CRF 
GCP 
IFU 
ISF 
MOR 
Pl 
electronic-Case Report Form 
Good Clinical Practice 
Instructions for Use 
Investigator Site File 
Medical Device Regulation (alias of the "Regulation (EU) 2017 /745 of the 
European Parliament and of the Council of 5 April 2017 on medical devices") 
Principal Investigator 
................................. ···········+·········· ....... . 
PMCF 
SADE 
SAE 
SOP 
UADE 
USADE 
VAS 
CONFIDENTIAL 
Post-Market Clinical Follow-Up 
Serious Adverse Device Effect 
Serious Adverse Event 
Standard Operating Procedure 
Unanticipated Adverse Device Effect 
Unanticipated Serious Adverse Device Effect 
Visual Analog Scale 
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Short Title: ALVE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
PROTOCOL SUMMARY 
Short Title 
ALVE study 
Full Title 
Prospective, multi centre clinical trial measuring the impact of treatment with 
ALVEOGYL in patients with post-extraction dry socket 
Study medical device 
Alveogyl 
Study objectives 
Primary obiective: 
Primary outcome 
To measure the impact of Alveogyl treatment on pain at 7-day post-
treatment. 
Secondary objective: 
To measure the impact of Alveogyl treatment on painkiller intake. 
To measure the impact of Alveogyl treatment on healing. 
To measure the impact of Alveogyl treatment on local inflammation. 
To measure the impact of Alveogyl treatment on antiseptic effect. 
To measure the impact of Alveogyl treatment on hemostasis. 
To measure the safety and complication rate of Alveogyl treatment. 
Pain Visua l Analog Scale (VAS) at 7 days post-treatment 
Secondary outcomes 
-
Painkiller intake: Analgesic use [ Time Frame: at 3 days, 5 days and 7 days 
post-treatment] 
-
Healing: Evaluation of healing of the alveolar mucosa. [ Time Frame: at 7 
days post-treatment]. 
-
Local inflammation: Signs of inflammation around the gingival mucosa 
(oedema, redness, sensitivity) [ Time Frame: at 7 days post-treatment]. 
-
Antiseptic effect: Clinical signs (e.g., gum pain, swollen gum lining, fever, 
halitosis). [ Time Frame: at 7 days post-treatment]. 
-
Hemostasis: presence or absence of bleeding [ Time Frame: after 
Alveogyl placement]. 
-
Safety: Complication rate [ Time Frame: From Alveogyl placement to 7 
days post-treatment] 
Study 
design 
and 
ALVE study is a clinical investigation assessing Alveogyl performance and 
methods 
CONFIDENTIAL 
safety in patients with post-extraction dry socket. The study will take place in 
India and in France where the study device is already marketed. 
In India, the study is regulatorily considered as a pivotal clinical study in 
accordance with the Indian regulation. 
In France -
European Union, the study is regulatorily considered as an 
observationa l, post-market clinical follow-up study with additional non-
invasive and non-cumbersome procedures: the clinical investigation is under 
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Short Title: ALVE 
Sponsor Code: 2022-A00208-35 
Study population 
Inclusion criteria 
Exclusion criteria 
Number of patients 
CONFIDENTIAL 
Sponsor: SEPTODONT 
the category "Other Investigation (Case 1: Clinical Investigation Post-Market 
Clinical Follow-Up)" in accordance with the European Medical Device 
Regulation (EU MOR). 
Management of dry socket application protocol is at the discretion of the 
Investigator. Patients treated with the study device will be screened and 
eligible patients will be included in the study after obtaining their consent. 
The primary outcome will be pain assessed by Visua l Analog Scale (VAS) for 
adults at 7 days post-treatment. VAS is a 10-point line from "no pain" (0 
point) to "worst imaginable pain" (10 points). A corresponding sca le will be 
used for children as appropriate. 
Additionally, patients will self-evaluate their pain level, their painkiller use 
and the feeling of Alveogyl (clove) taste at day 3 and day 5 at home. 
All data will be recorded in either paper or electronic Case Report Form (CRF) 
and monitored by the Sponsor's designee. Self-evaluation by the patients will 
be recorded in a paper datasheet. 
All patients with permanent teeth are eligible to participate into the study: 
Male and fema le patients, adults and children. 
Note: Age of study popu lation is defined by the permanent tooth 
requirement as first permanent teeth erupt on children. 
-
Male or female patient, adult or child 
-
Positive diagnosis of dry socket occurring after the extraction of a 
permanent tooth (mature or immature) 
-
Signed informed consent 
-
Patient affiliated to a Health Insurance Scheme ("securite socia le") 
-
Spreading infecti on in the alveolar socket 
Placement of Alveogyl done immediately after tooth extraction 
Multiple post-extraction dry sockets 
Patient treated with cervico-facial radiotherapy 
Immunodeficiency related to any diseases or current treatments 
Psychiatric patient or patient unable to assess his/her pain via the study 
Pain VAS 
Patient with history of hypersensitivity to one of the components 
Patient on post extraction of deciduous teeth 
Participation in another clinical investigation 
120 patients 
It is estimate that about 90 patients wi ll be included in India in about 10 
investigational sites, and about 30 patients will be included in France in 2 
investigational sites. 
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Short Title: ALVE 
Sponsor: SEPTODONT 
Sponsor Code: 2022-A00208-35 
Follow-up(s) 
Patients will be evaluated at visit 1 - Day O and clinically followed at 7-day 
post-treatment (visit 2 - Day 7). 
Some data will be collected at home, at Day 3 and Day 5: Pain VAS, painkiller 
use, and feeling of Alveogyl (clove) taste. 
Study duration 
Patient enrolment will last 30 months (estimate). 
Each patient's participation will last 8 days. 
The entire study is expected to last 30.5 months. 
St atistica I 
and 
The assumption is that 92% of patients will have no pain or mild pain at Day 7 
analytic plan 
(primary outcome). This assumption is supported by the literature that 
reports a mean pain of 1.4 with standard deviation of 1.1 at Day 7, leading to 
a very large probability that patients have no pain/ mild pain (VAS<4) at 
Day 7. 
The sample size n=120 is based on the half-width (precision) of the 95% 
confidence interval of p=0.92: with n=113, the half-width wi ll be 0.05 and 7 
patients are added in case of a few non-evaluable patients. 
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Short Title Al VE 
Sponsor Code: 2022-A00208-35 
Table 1: Schedule of Study Procedures 
TIM ELI NE 
Informed Consent 
Review Inclusion/Exclusion Criteria 
Demographics/Medical History of interest 
Prior/Concomitant Medications of interest 
Clinical examination ** 
Pain evaluation based on VAS 
Treatment with Alveogyl paste 
Evaluation of the presence of Alveogyl paste (via its clove taste) 
in the socket 
Evaluation of painkiller use 
Serious and non-seriou s adverse events assessment 
Device deficiency 
DayO 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Day 3 
Day 5 
X 
X 
X 
X 
X 
X 
* 
Investigator will report at Visit 2 - Day 7 all safety issues (serious and non-serious adverse events and device deficiencies) which occur since Visit 1 -Day 0 
Sponsor: SEPTODONT 
Day7 
X 
X 
X 
X 
X* 
X* 
* * Including evaluation of the alveolus healing status, evaluation of the mucosa inflammation status, evaluation of bleeding status, and of the presence/absence of superinfection. 
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Short Title: ALVE 
Sponsor: SE PTO DO NT 
Sponsor Code: 2022-A00208-35 
1 BACKGROUND AND RATIONALE 
1.1 
BACKGROUND AND RATIONALE FOR THE CLINICAL INVESTIGATION 
Dry socket (or alveolar osteitis), is the most common complication following a dental extraction [1) and 
one of the most studied complications in dentistry [2). The incidence of dry socket varies between 1 % 
and 5% of all dental extractions, with up to 38% of dry socket cases associated with mandibular third 
molars [3], [4]. Dry socket develops as a postoperative complication when a blood clot fails to develop, 
dissolves, or dislodges at the site of the extraction before the socket is healed [5]. Socket that has been 
left exposed might be accumulated with food debris and bacterial biofilms that further hinder the 
healing process of the socket. Moreover, bacteria col lected inside the socket may even ferment the 
food particles inside it, which in turn exacerbates the already compromised situation of the socket. Most 
commonly, patients suspected of suffering from dry socket present with acute pain from the exposed 
socket that lingers for many days until the socket is completely covered by the epithelium. 
The treatment of alveolitis depends on each professional's clinical experience mainly due to the fact of 
its complex etiology. Traditionally, the treatment of dry socket has been irrigation, surgical intervention, 
and placement of medicated dressings. 
Alveogyl (Septodont, Saint-Maur-des-Fosses - France) is a paste used as dressing in case of dry socket. 
Alveogyl has been sold and used worldw ide since 2010; Alveogyl is one of the treatments advised for 
clinical management of alveolar osteitis. 
Regulatory context in India: 
Alveogyl is a Class B medical device according to current Medical Device Regulations (Medical Devices 
Rules 2017) and COSCO Notice File NO. 29/Misc/3/2018-DC(85) dated 06/06/2018 Annexure 1. 
In the context of recommendations of the Subject Expert Committee to perform a pivotal clinical 
investigation in India to support the registration of Alveogyl under the Drugs & Cosmetics Act 1940 & 
Rules 1945 and Medical Device Rules 2017, this study is put in place with the aim to confirm the safety 
and efficacy (performance) of Alveogyl in the treatment of dry socket. 
Regulatory context in France and Europe: 
Alveogyl is CE-marked as a class Ila medical device according to article 9 and rule 7 of the annex IX of 
Directive 93/42/EEC intended to be used in dentistry. 
The results of this clinical study will be part of the clinical evidence for supporting the device claims and 
for CE-marking under the Eu ropean Medical Device Regulation (MOR) 2017 /745. 
1.2 
CLINICAL EVIDENCE TO DATE 
In 2009, a double-blind, randomized, controlled pilot study in 106 patients has been performed to 
evaluate the performance and the clinical safety of two new pastes developed by Septodont: RD113/06 
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Short Title: ALVE 
Sponsor: SE PTO DO NT 
Sponsor Code: 2022-A00208-35 
(35 patients) and RD113/08 {36 patients) in the treatment of dry socket in comparison to Alvogyl (35 
patients). RD113/08 was the project name for the current commercialized and study device Alveogyl. 
Results of the study showed that Alveogyl provides a favourable environment for the healing of the 
alveolar mucosa and is considered as safe for patients with a dry socket. 
No publication exists on this study, only a clinical report in French is available upon request. 
1.3 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION 
The study device Alveogyl is a paste already marketed and used in India and France for several years (8 
years in India, 12 in France). 
ALVE study is a clinical study assessing Alveogyl performance and safety in patients with post-extraction 
dry socket. 
Efficacy of a method used for dry socket management is usually measured through the relief of patient's 
pain and the promote of alveolar mucosa healing [6]. The study objectives and outcomes measured 
were notably based on this information. 
Additionally, the following clinical performance and clinical safety parameters claimed by the 
manufacturer for the study device will be verified through the results obtained in the current study: 
Provides a favourable environment for physiological tissue healing, 
Reduces pain, 
Reduces local inflammation and reduces risks of contamination due to its barrier effects. 
Hemostasis support 
1.4 
JUSTIFICATION OF THE CHOICE OF THE INVESTIGATION POPULATION 
The target population for this study is the same as the intended popu lation specified in the study 
device's instru ctions for use: patients with permanent teeth (mature or immature). 
As permanent teeth can erupt in chi ldren (permanent teeth typically begin erupting around age 5), 
minors are eligible to participate in the study. Other vulnerable patients can be included in the study as 
there is no additional ri sk for this population. 
1.5 
RISK EVALUATION (RISK-TO-BENEFITS RATIONALE) 
1.5.1 
Anticipated clinical benefits 
It is expected that Alveogyl provides the following clinical benefits: 
Pain reduction 
Inflammation redu ction 
Limit infection with its barrier effect 
1.5.2 
Anticipated adverse events related to device or procedure 
The following possible adverse events related to the device or to the procedure of dry socket treatment 
have been identified during clinical evaluation and ri sk analysis: 
Mouth ulceration, 
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Short Title: ALVE 
Sponsor Code: 2022-A00208-35 
Pain, 
Paresthesia, 
Infections (osteitis, abscess), 
Swelling, 
Hypersensitivity/irritation reactions 
Local inflammation, 
Temporary fever, 
Bleeding gum, 
Delayed healing, 
Sponsor: SE PTO DO NT 
Possible increased bone resorption (the material should be removed in the area that receives 
future implants), 
Ulceration. 
1.5.3 
Risks associated with participation in the clinical investigation 
Septodont's last Clinical Safety Review analysis reported that Alveogyl is safe under the 
recommendation of use: there is indeed, up to 31-Dec-2020, only 22 reported cases out of 40 489 595 
patients exposed. All the reported safety concerns retrieved are identified as either being associated 
with the dental procedure (i.e., paresthesia, dysaesthesia, pain) or to the product itself (irritation, 
hypersensitivity). 
As the study medical device is used in its indication according to the Instructions For Use (IFU) with only 
collection of clinical data, there is no additional risks associated with patients participation in this clinical 
study. The patient will be treated as per standard practice and following the IFU (see Annex 1). 
1.5.4 
Possible interaction with concomitant medical treatments as considered under the risk analysis 
There is no interaction with a concomitant medical treatment that may present a risk. 
1.5.5 
Steps that will be taken to control or mitigate the risks 
All identified risks have been estimated and evaluated according to the risk management plan and the 
results are logged in the risk analysis table of the study device (see Annex 2). 
Each risk has been reduced as far as possible, using risk control measures when possible. All the risk 
control measures have been implemented. 
After implementation of all risk control measures, there is no unacceptable residual risk. 
All the information for safety that has emerged from the risk analysis has been included in the 
instructions for use, including risk control measures and residual risks. 
1.5.6 
Rationale for benefit-risk ratio 
The clinical risks of the study device are consistent with the state-of-the-art (based on competitors' 
products results in the same indication). The overall residual risk is considered acceptable. 
The clinical evaluation of the study device concluded on a favourable benefit-risk ratio of Alveogyl in 
patients with dry socket as the product provides a favourable environment for physiological tissue 
healing. 
The results of this clinical study should confirm the favourable benefit-risk ratio. 
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Short Title: ALVE 
Sponsor: SE PTO DO NT 
Sponsor Code: 2022-A00208-35 
2 
DESCRIPTION OF THE STUDY DEVICE 
2.1 
STUDY DEVICE 
2.1.1 
Description 
The name of the study medical device is Alveogyl. 
In India, Alveogyl is a Class B medical device according to current Indian Medical Device Regulations 
(Medical Devices Rules 2017) and COSCO Notice File NO. 29/Misc/3/2018-DC(85) dated 06/06/2018 
Annexure 1. 
In Europe, Alveogyl is a CE-marked Class Ila medical device according to article 9 and rule 7 of the annex 
IX of Directive 93/42/EEC intended to be used in dentistry. 
The product is commercialized in Europe since 2010 and in India since 2014 and is currently on the 
market in nearly 90 countries worldwide. 
Alveogyl is a paste used as dressing to treat dry socket and is intended to be applied on the patient's 
dental socket by a dental professional on ly. 
Composition and role of the materials are detailed in the following table. 
Table 2: Composition of Alveogy/ 
Raw material 
CAS number 
Quantity (g/lO0g) 
Role 
-
-
1111 
Eugenol 
-
1111 
Calcium carbonate 
-
1111 
Mint natural flavor 1111 
I 
-
Penghawar -
-
djambi fiber 
Sodium dodecyl sulfate -
-
The product is packaged in a jar containing 10g of Alveogyl as presented in the following picture. 
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Short Title: ALVE 
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Obturator L 
'
Al•'fUt)t 
----EJ 
j 
-:::: ··-
1
• 
•, 
Card Box 
I .... c~ .~ 
Packaging level 
Primary packaging 
Secondary/sales 
packaging 
._____I""-
~ 
Component 
Glass bucket/ jar 
Obturator 
Cap 
Card Box 
... ,~ 
Raw material 
-
Figure 1: Primary and secondary packaging of Alveogyl 
2.1.2 
Intended purpose 
Dry-Socket Surgical dressing. 
NOTE: Please refer to the !FU for more information. 
2.1.3 
Indications 
Alveogyl is a paste used as dressing in case of dry socket. 
NOTE: Please refer to the !FU for more information. 
2.1.4 
Patient population 
Patient with permanent teeth (mature or immature). 
NOTE: Please refer to the !FU for more information. 
2.1.5 
Users 
For professional dental use only. 
NOTE: Please refer to the !FU for more information. 
2.1.6 
Experience/ Training needed 
Sponsor: SEPTODONT 
There is no special training needed to use the study device as it is a CE-marked device used for several 
years and already in the Indian and French market and has similar use as other pastes in the market. 
2.2 
MANUFACTURER 
Septodont 
58 Rue du Pont de Creteil, 94100 Saint-Maur-des-Fosses - FRANCE 
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Short Title: ALVE 
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3 STUDY OBJECTIVES AND ENDPOINTS 
3.1 
STUDY OBJECTIVES 
3.1.1 
Primary objective 
To measure the impact of Alveogyl treatment on pain at 7-day post-treatment. 
3.1.2 
Secondary objectives 
To measure the impact of Alveogyl treatment on painkiller intake. 
To measure the impact of Alveogyl treatment on healing. 
To measure the impact of Alveogyl treatment on local inflammation . 
To measure the impact of Alveogyl treatment on antiseptic effect. 
To measure the impact of Alveogyl treatment on hemostasis. 
To measure the safety and complication rate of Alveogyl treatment. 
3.2 
STUDY ENDPOINTS 
3.2.1 
Primary endpoint 
Pain Visua l Analog Sca le (VAS) at 7 days post-treatment 
3.2.2 
Secondary endpoints 
Sponsor: SE PTO DO NT 
Painkiller intake: Analgesic use [ Time Frame: at 3 days, 5 days and 7 days post-treatment] 
Healing: Evaluation of healing of the alveolar mucosa. [ Time Frame: at 7 days post-treatment]. 
Local inflammation: Signs of inflammation around the gingival mucosa (oedema, redness, sensitivity) 
[ Time Frame: at 7 days post-treatment]. 
Antiseptic effect: Clinical signs (e.g., gum pain, swollen gum lining, fever, halitosis). [ Time Frame: at 7 
days post-treatment]. 
Hemostasis: presence or absence of bleeding [ Time Frame: after Alveogyl placement]. 
Safety: Complication rate [ Time Frame: From Alveogyl placement to 7 days post-treatment] 
4 
INVESTIGATIONAL PLAN 
4.1 
STUDY DESIGN 
ALVE study is a clinical investigation assessing Alveogyl performance and safety in patients with post-
extraction dry socket. The study will take place in India and in France where the study device is already 
marketed. 
In India, the study is regulatorily considered as a pivotal clinical study in accordance with the Indian 
regulation. 
In France - European Union, the study is regulatorily considered as an observational, post-market 
clinical follow-up study with additional non-invasive and non-cumbersome procedures: the clinical 
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investigation is under the category "Other Investigation (Case 1: Clinical Investigation Post-Market 
Clinical Follow-Up)" in accordance with the European Medical Device Regulation (EU MOR). 
Management of dry socket application protocol is at the discretion of the Investigator. Patients treated 
with the study device will be screened and eligible patients will be included in the study after obtaining 
their consent. 
The primary outcome will be pain assessed by Visual Analog Scale (VAS) for adults at 7 days post-
treatment. VAS is a 10-point line from "no pain" (0 point) to "worst imaginable pain" (10 points). A 
corresponding scale will be used for children as appropriate. 
Additionally, patients will self-evaluate their pain level, their painkiller use and the feeling of Alveogyl 
(clove) taste at day 3 and day 5 at home. 
All data will be recorded in either paper or electronic Case Report Form (CRF) and monitored by the 
Sponsor's designee. 
4.2 
STUDY DURATION, ENROLMENT AND SITES 
4.2.1 
Duration of enrolment 
Patients' enrolment will last 30 months (estimate). 
4.2.2 
Duration of study participation 
Each patient will be clinically examined at visit 1- Day 0 (at the time of positive diagnosis of dry socket 
and use of Alveogyl) and at 7 days post-treatment (visit 2 - Day 7). 
Each patient's participation will last 8 days. 
4.2.3 
Number of investigational sites and patients estimated 
120 patients will be enrolled in the clinical study. 
The clinical study will be conducted at approximately 10 investigational sites in India which should 
recruit about 90 patients, and at 2 sites in France which should recruit about 30 patients. 
4.3 
STUDY POPULATION 
4.3.1 
Inclusion criteria 
Patient fulfilling all the following criteria is eligible for the clinical investigation: 
Male or female patient, adult or child 
Positive diagnosis of dry socket occurring after the extraction of a permanent tooth (mature or 
immature) 
Signed informed consent 
Patients affiliated to a Health Insurance Scheme ("securite sociale") 
4.3.2 
Exclusion criteria 
The presence of any of the following exclusion criteria will lead to the exclusion of the patient: 
Spreading infection in the alveolar socket 
Placement of Alveogyl done immediately after tooth extraction 
Multiple post-extraction dry sockets 
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Patient treated with cervico-facial radiotherapy 
Immunodeficiency related to any diseases or current treatments 
Psychiatric patient or patient unable to assess his/her pain via the study Pain VAS 
Patient with history of hypersensitivity to one of the components 
Patient on post extraction of deciduous teeth 
Participation in another clinical investigation 
4.4 
PATIENT INFORMATION AND INFORMED CONSENT 
Sponsor: SE PTO DO NT 
The Principal Investigator (Pl) or designee explains to each patient the nature of the study, its purpose, 
the procedures involved, the expected duration, the potential risks and benefits and any discomfort it 
may entail. Each patient is informed that the participation in the study is voluntary and that he/she may 
withdraw from the investigation at any time and that withdrawal of consent will not affect his/her 
subsequent medical assistance and treatment. The patients are informed that he/she can ask any 
question. Time is given to the patients to read and understand the consent form. 
The patients are informed that authorised individuals other than their treating physician may examine 
his/her medical records. 
All patients are given a patient information document and a consent form describing the study and 
providing sufficient information for the patients to make an informed decision about their participation 
in the study. 
The formal consent of a patient, using the approved consent form, is obtained before the patient is 
enrolled into the study and submitted to any study procedure. 
The patient should read, understand, and voluntarily agree before signing and dating the informed 
consent form, and is given a copy of the signed document. The consent form is signed and dated by the 
patient and the Pl (or her/his designee). The signed consent form is then retained as part of the 
investigation records. 
4.4.1 
Minors/underage patients 
For minor/underage patients the study's investigator or designee will discuss with the patient's parent 
or legal representative, who may give his/her informed consent on the patient's behalf. The minor 
patient will also be informed about the study within his/her ability to understand: a dedicated 
information sheet will be provided to the minor patient. 
4.4.2 
Other vulnerable subiects 
Other vulnerable patients can be included in the study (i.e. individuals with lack or loss of autonomy due 
to immaturity or disability, persons in nursing homes, impoverished persons, subjects in emergency 
situations, ethnic minority groups, homeless persons, nomads, refugees, and persons kept in detention). 
There is no additional risk nor contraindication for this type of population. 
If the patient is unable to make the decision to participate in this study, the study's investigator or 
designee will discuss with the patient's legal representative. 
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4.5 
STUDY PROCEDURES 
4.5.1 
Visit 1- Day 0 
During this visit (same day as dry socket diagnostic and procedure of Alveogyl treatment), the following 
elements will be performed: 
IZI Eligibility criteria: Prior to patients' enrolment into the study, patients' inclusion and exclusion criteria 
will be reviewed by the investigator. 
IZI Patient informed consent: see §4.4 
IZI Medical record review: which will be extracted from the patients' medical chart (i.e., Date of birth 
(MM-YYYY), gender, risk factors); medical information related to tooth extraction and dry socket before 
the procedure (such as date of tooth extraction, numbered of the extracted tooth, etiology of the tooth 
extracted, ... ); Concomitant therapy. 
IZI Clinical signs or symptoms: such as presence of gum infection/periodontitis, time after which the 
pain started, blood clot within the alveolar socket, halitosis, confirmation of the diagnosis of dry socket, 
local inflammation evaluation, bleeding evaluation, ... 
IZI Visual Analog Scale: pain assessment through the VAS before the procedure 
Placement of Alveogyl use is done according to the instruction for use (IFU, Annex 1) 
Before inserting the paste, the socket shall be re-examined. 
The inside of the socket should be thoroughly cleaned (i.e., irrigated and/or curetted) to remove all 
debris. 
Take a small pellet (about 0.20 g) of paste and place it gently into the prepared dental socket. Do not 
suture. 
Note 1: The management of dry socket paste application protocol is at the discretion of the Investigator, 
knowing that there are available guidelines (e.g., Canadian Dental Association, 2013). 
Note 2: For more details on the procedure of use, precautions and warnings see IFU. 
The following information will be collected: 
IZI Clinica l signs or symptoms: medical information related to dry socket 
IZI Procedure information: type of pre-Alveogyl treatment (curettage, cleaning, local anaesthesia etc.); 
feedbacks on the study device (manipulation, consistency, placement); Post-Alveogyl treatment 
information (local inflammation evaluation, bleeding evaluation, ... ) 
IZI Visual Analog Scale: pain assessment through the VAS after the procedure 
4.5.2 
Follow-up visit (Visit 2 - Day 7) 
During patients' follow-up visit at 7-day post-treatment, the following elements will be evaluated: 
IZI Clinical signs or symptoms: medical information related to dry socket (local inflammation evaluation, 
infection of the studied socket, healing evaluation, presence or not of Alveogyl paste in the socket, ... ) 
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IZI Serious and non-serious adverse events and Alveogyl deficiency since Visit 1 (See §6.3) 
IZI Visual Analog Scale: pain assessment through the VAS 
IZI Painkiller use 
Additionally to the clinical follow-up visit at 7-day post-treatment, patients have to complete at home 
a form at Day 3 and Day 5 post-treatment with the following information to collect: 
IZI Visual Analog Scale: pain assessment through the VAS 
IZI Presence or not of Alveogyl clove taste feeling 
IZI Painkiller use 
4.5.3 
Unscheduled visits 
Patients may come back before the scheduled visit at 7 days post-treatment for various reasons (e.g., 
pain, other adverse events). In this case, the following information will be recorded in the study CRF: 
• 
Date of the visit 
• 
Reason of the visit 
• 
Clinical signs or symptoms: medical information related to dry socket (local inflammation 
evaluation, infection of the studied socket, healing evaluation, presence or not of Alveogyl paste 
in the socket, ... ) 
• 
Type of treatment if applicable and information on whether if Alveogyl was re-used during the 
visit . 
4.5.4 
Patient completion/Withdrawal 
Patients may withdraw from the study at any time without prejudice to their care. They may also be 
discontinued from the study at the discretion of the Investigator for lack of adherence to study 
treatment or visit schedules or A Es. 
The Investigator may also withdraw patients who violate the study plan, or to protect the patients for 
reasons of safety or for administrative reasons. It will be documented whether each patient completes 
the clinical study. If the Investigator becomes aware of any serious, related adverse events after the 
patient completes or withdraws from the study, they will be recorded in the source documents and on 
the CRF. 
4.6 
STUDY EARLY TERMINATION 
The Sponsor may terminate the study prematurely according to certain circumstances, for example: 
a) 
ethical concerns, 
b) 
insufficient patient recruitment, 
c) 
when the safety of the patient is doubtful or at risk, respectively, 
d) alterations in accepted clinical practice that make the continu ation of the investigation unwise, 
e) 
early evidence of benefit or harm of the experimental intervention. 
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The Sponsor may terminate the inclusion of patients at a study site at any time after the study initiation 
visit. Specific instances that may precipitate such termination are: 
a) 
multiple or severe CIP violations, or non-compliance without justification and/or repeated 
failure to follow remedial actions 
b) 
unauthorized use of the study device in another clinical study 
c) 
no patients have been enrolled 
d) 
inaccurate and/or incomplete data record ing on a recurrent basis 
In the event of termination of Investigator participation, all study materials, as applicable, must be 
returned to the Sponsor, unless this action would jeopardize the rights, safety or well-being of the 
patients. The Ethic Committee (EC/IRB) and Competent/Regulatory Authority (CA/RA), if applicable, 
shou ld be notified. 
5 STATISTICAL METHODS 
5.1 
HYPOTHESIS 
The assumption is that the use of Alveogyl will allow to get a minimal residual pain at Day 7 post-
treatment. 
5.2 
DETERMINATION OF SAMPLE SIZE 
The determination of the sample size is based on the assumption that 92% of patients will have no pain 
or mild pain at Day 7 after the use of Alveogyl. The pain is assessed through a 10-point visual analogic 
scale (VAS) and a score strictly less than 4 is considered as mild pain or no pain [7]. 
The assumption of 92% is supported by the literature that reports a mean pain of 1.4 with standard 
deviation of 1.1 at Day 7, leading to a very large probability that patients have no pain/ mild pain (VAS<4) 
at Day 7 [8]. 
The selected sample size is n=120, which will allow to estimate the proportion of no pain or mild pain 
with a satisfactory precision: the half-width of the 95% confidence interval of p=0.92 is 0.05 with n=113 
patients and 7 patients are added in case of a few non-evaluable patients at Day 7 post-treatment. 
5.3 
STATISTICAL CRITERIA OF TERMINATION OF THE STUDY 
N/A. As this is a study with a device already in the market, it is not expected that the study device will 
do any harm to the patient that wou ld justify an early termination of the study. Any unexpected serious 
adverse events will be reported and analysed by Septodont vigilance department. 
5.4 
STATISTICAL METHODS FOR PLANNED ANALYSES 
A statistical analysis plan wil l be developed separately. 
Quantitative data will be reported with n, n missing, mean, standard deviation (SD), median, minimum, 
maximum and l51 and 3rd quartiles. 
Qualitative data will be reported as n, n missing and percentage (calculated over the non-missing data). 
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5.4.1 
Analysis populations 
Included population (intention-to-treat population - ITT): all included patients. 
Evaluable population (per-protocol population - PPP): all patients from the included population with no 
exclusion criteria and with VAS available at Day 7. 
5.4.2 
Baseline Data 
Baseline data will be described in the included population: demography, characteristics of the tooth 
extraction, clinical characteristics of the dry socket will be reported. The pain measured with VAS just 
before the treatment with Alveogyl and just after will be described as well as the clinical signs just after 
the placement of Alveogyl (local inflammation, bleeding). 
The ease of use for the dentist will be described too. 
In case the size of the evaluable population is much smaller than the included population {10% less), 
the description of baseline data of the patients will be performed also in the evaluable population. 
5.4.3 
Analysis of Primary endpoint 
The primary endpoint is the binary variable (yes/ no) defined as the VAS at Day 7 < 4 (i.e., "Yes" when 
VAS is <4, "No" when VAS is ~4). 
It will be reported with a percentage and a 95% confidence interval (with the exact method) in the 
evaluable population. 
5.4.4 
Analysis of Secondary endpoints 
The secondary analyses will consist of: 
Evolution of VAS from the day (DO) of use of Alveogyl to 7 days post treatment. Summary statistics 
of VAS will be provided at Day DO, D3, D5 and D7 in available observations (no imputation for missing 
values will be made). For each time point, difference with measure at DO will also be calculated. 
The complication rate will be calculated: number and proportions of the events (quoted in §1 .5.2) 
occurring post treatment 
Description of the clinical signs at D7 and at intermediary visits (if any) to measure the impact of 
Alveogyl treatment on healing, on antiseptic effect, on local inflammation, and on hemostasis: 
number and proportions. 
The use of painkillers at D3 and at D7 will be described. 
A listing of the adverse events (AE) will be provided organized by type of AE (Adverse Event; Adverse 
Effect related to Alveogyl; Deficiency of Alveogyl; Other type or Unknown) 
5.4.5 
Interim analyses 
N/A. No interim analysis is planned. 
5.4.6 
Deviation(s) from the original statistical plan 
If any, additional analyses or changes from the initial plan will be described in the study report. 
5.5 
HANDLING OF MISSING DATA AND DROP-OUTS 
No data will not be imputed, only available data will be used in the analyses. 
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6 SAFETY MANAGEMENT 
6.1 
DEFINITIONS 
For sake of clarity, the source of each definition wording is given between brackets. 
Adverse Event (AE) (Art. 2 §57 MDR) 
Any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including 
an abnormal laboratory finding) in subject s, users or other persons whether or not related to the 
Medical Device. 
Adverse Device Effect (ADE) (ISO14155) 
Adverse event possibly, probably or causally related to the use of an investigational device or 
procedures. 
Use error (ISO14155) 
User action or lack of user action while using the medical device that leads to a different result than that 
intended by the manufacturer or expected by the user 
Incident (Art. 2 §64 M DR) 
Any malfunction or deterioration in the characteristics or performance of a device made available on 
the market, including use-error due to ergonomic features, as well as any inadequacy in the information 
supplied by the manufacturer and any undesirable side-effect 
Malfunction (ISO14155) 
Failure of an investigational device t o perform in accordance with its intended purpose when used in 
accordance with the instructions for use or the CIP. 
Device deficiency (Art. 2 §59 MDR) 
Inadequacy of a medical device related to its identity, quality, durability, reliability, safety or 
performance, of an investigational device, including malfunction, user errors and inadequate 
information supplied by the manufacturer. 
Serious Adverse Event (SAE) (Art. 2 §58 MDR) 
Any adverse event that led to any of the following: 
(a) death, 
(b) serious deterioration in the health of the subject that resulted in any of the following: 
(i) life-threatening illness or injury, 
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(ii) permanent impairment of a body structure or a body function, 
(iii) hospitalisation or prolongation of patient hospitalisation, 
Sponsor: SE PTO DO NT 
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
(v) chronic disease, 
(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. 
Note: planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a 
serious deterioration of the health status of the subject, is not considered an SAE. 
Serious Adverse Device Effect (SADE) (ISO14155) 
Adverse device effect (ADE) that has resulted in any of the consequences characteristic of a serious 
adverse event. 
Unanticipated Serious Adverse Device Effect (USADE) (ISO14155) 
Serious adverse device effect (SADE) which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
Device deficiency with Serious Adverse Device Effect (SADE) potential ((Art. 80 § 1 c) M DR; ISO14155) 
Any device deficiency that might have led to a serious adverse event if appropriate action had not been 
taken, intervention had not occurred, or circumstances had been less fortunate. 
Serious incident: (Art. 2 § 65MDR) 
Means any incident that directly or indirectly led, might have led or might lead to any of the following: 
(a) the death of a patient, user or other person, 
(b) the temporary or permanent serious deterioration of a patient's, user's or other person 's state of 
health, 
(c) a serious public health threat; 
Serious public health threat: (Art. 2 § 66MDR) 
Event which cou ld result in imminent risk of death, serious deterioration in a person's state of health, 
or serious illness, that may require prompt remedial action, and that may cause significant morbidity or 
mortality in humans, or that is unusual or unexpected for the given place and time. 
Causal Relationship of SAE (MDCG 2020-10/1) 
A causal relationship towards the medical device or the proced ure of the investigation should be rated 
by the Pl and the Sponsor as follows: 
e) 
Not related: The relationship to the device or procedures can be excluded. 
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f) 
Possible: The relationship with the use of the investigational device is weak but cannot be ruled 
out completely. Alternative causes are also possible. 
g) 
Probable: The relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably be explained by another cause. 
h) 
Causal relationship: The serious event is associated with the investigational device or with 
procedures beyond reasonab le doubt. 
6.2 
SAFETY DATA RECORDING 
From the "Visite 1 - Day 0" date until patient end of study (i.e., withdrawal/end of follow-up/lost to 
follow-up), all adverse events (serious and non-serious), exposure during pregnancy and device 
deficiencies that occur will be fully investigated, recorded and classified by the Investigator in line with 
the definitions provided in the norm ISO14155:2020 and guideline MEDDEV 2.7/3. 
Investigators will check patients file during clinical follow-up visit and ask patients if they experienced 
any complications since the index procedu re / last visit. 
Safety data will be reported in the Case Report Form. 
Documentation of AEs (including SAEs) by the Pl includes diagnosis or symptoms, start and stop dates 
of event, event treatment, event resolution, assessment of seriousness and causal relationship to 
Medical Device and/or investigation procedure (ISO14155). 
Documentation of ODs by the Pl includes description of event, start date, investigational device 
information, action taken with regard to the investigational device, and whether the DD led to an AE. 
The Sponsor shall review all ODs and determine and document in writing whether they cou ld. 
The Sponsor provides the Competent/Regulatory Authority (CA/RA) (if applicable) and the Ethic 
Committee (EC/IRB) with the documentation at their request. 
6.3 
SAFETY DATA REPORTING 
6.3.1 
Reporting to the Sponsor 
The following events are to be reported to the Sponsor by the Pl (or authorized designee) without delay 
and not later than 3 calen dar days after becoming aware of the event: 
All SAEs related and unrelated to the studied device 
Health hazards that require measures 
Unanticipated Seri ous Adverse Device Effect 
Device deficiencies including use error, malfunction, and incident irrespectively of occurrence 
of AE. 
Non serious AE and exposure to the device during pregnancy are transmitted weekly to the sponsor. 
Safety data as described above in section 6.1 Definition in addition to exposure during pregnancy are 
reported in the dedicated form: CRF and vigilance report form provided by the sponsor available in the 
Investigator Site File and send to the sponsor according to the timelines described above by email to 
copy 
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In case of serious public health threat or in case of death or unanticipated serious deterioration in a 
person's state of health, the sponsor must be informed immediately by phone (tel: 
■ 
and the dedicated form sent in parallel by email. 
A detailed follow-up report containing all additional exams and/or pseudonymized surgical report 
should be sentto the sponsor as soon as they are available according to the same process and timelines. 
The Sponsor will evaluate SAEs with regard to causality and seriousness. Device deficiencies are also 
assessed regarding their potential to lead to an SAE (DD with SADE potential). 
The Sponsor will manage the information on safety according to its procedure. 
Reconciliation with the CRO and Septodont medical affairs department are performed in monthly basis 
with Septodont vigilance department. 
Appropriate vigilance training is provided to the CRO. 
6.3.2 
Reporting to Ethic Committee and Competent/Regulatory Authority 
The sponsor will submit the case reports to the Ethic Committee and to Competent/Regulatory 
Authority as required in the country regulation. 
In France: 
It is done according to the timelines described in the Article 87 and 90 of the M DR: 
• 
a serious public health threat must be reported immediately and not later than 2 days after the 
manufacturer becomes aware of that threat 
• 
in the event of death or unanticipated serious deterioration in a person's state of health, the 
reporting to the CEC must be performed immediately and not later than 10 days after the 
manufacturer becomes aware of that threat 
• 
in case of any serious incident and after having established the causal relationship between the 
incident and the device (or such causal relationship is reasonably possible), the reporting to the 
CEC must be performed immediately and not later than 15 days after the manufacturer become 
aware. 
In India: 
All SAE/SADE/USADEs must be reported to the sponsor/legal representative and manufacture within 24 
hrs of the investigator team becoming aware of them. 
All the SAE/SADE/USADEs will be reported to Institutional Review Board/ Ethics Committee as per local 
regulatory requirements through an email or telephonically, and Reports of related and unexpected 
SAEs shou ld be submitted to Ethics Committee within 14 days of the Chief Investigator becoming aware 
of the event, using the SAE report form. 
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Full details of the event, treatment, and an assessment of the relationship to study procedures must be 
provided in the report with detailed information as mentioned in table 7 of Medical Device Rule 2017, 
DCGI or latest local regulatory requirement. 
The Investigator should institute appropriate therapeutic and follow-up measures in accordance with 
good medical practice but should notify the monitor of such actions and record them in the subject's 
Case Report Form. 
6.4 
ADVERSE EVENTS CATEGORIZATION 
The adverse events are categorized by the Pl and the Sponsor using the following algorithm: 
Does the AE meet the seriousness criteria? 
1. 
No, it is not serious 
Is the relationship to the device or the procedure possible, probable or causal? 
o 
No: non-related AE 
o 
Yes: ADE 
2. 
Yes, it is serious: SAE 
Is the relationship to the device or the procedure possible, probable or causal? 
o 
No: non-related SAE 
o 
Yes: SADE 
Is it anticipated (within expected type, severity and frequency of the complications)? 
1. 
No: unanticipated SADE (USADE) 
2. 
Yes: anticipated SADE (ASADE) 
6.5 
EMERGENCY CONTACT 
In case of serious public health threat or in case of death or unanticipated serious deterioration in a 
person's state of health, or any major safety issue the sponsor must be informed immediately by phone 
tel: 
and an email is sent with the CRF and vigilance report form sent in parallel by 
copy 
In India, investigator must also contact his/her contact CRO monitor as defined in investigator's site 
binder. 
6.6 
DATA MONITORING COMMITTEE 
N/A 
7 
ETHICAL AND REGULATORY ASPECTS 
The final positive decision of the EC/IRB and of the CA/RA (if applicable) on the conduct of the 
investigation will be made and given in writing to the Sponsor before the study can start. Additional 
requirements set by the authorities must be implemented. 
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7.1 
REGISTRATION OF THE STUDY 
The study is registered in France under the following RCB number: 2022-A00208-35 and in India under 
the following number CI/MD/2022/66273. 
7.2 
STUDY APPROVAL 
7.2.1 
Ethics Committee (EC/IRB) 
The sponsor will submit the study to the Ethics Committee (EC/IRB) and obtain EC/IRB approval before 
the start of the study. Each Pl at each participating site ensures that approval from the EC/IRB is 
obtained and filed in the Investigator Site File (ISF) before the study starts. 
Substantial amendments are submitted for approval. The regular or premature end of the study as well 
as the interruption of the study is reported to the EC/IRB. The reasons for a premature end or an 
interruption have to be explained. 
A final report shall be submitted within one year after the regular end of the study and within 3 months 
after a premature end of the investigation. 
7.2.2 
Competent/regu latory authorities (CA/RA) 
The Sponsor will submit the investigation to the CA/RA and obtain regulatory approval (if applicable) 
before the start of the study. Each Pl at each participating investigational site ensures that approval 
from the CA/RA is obtained and filed in the Investigator site file before the study starts. 
Any additional requirements imposed by the EC/IRB or CA/RA sha ll be followed. 
7.3 
COMPLIANCE STATEMENT 
This clinical study will be conducted in full accordance with local Regulation Authority, the Norms 
ISO14155:2020 and ISO14971, the !CH-guidelines of Good Clinical Practice (GCP) as applicable, this CIP, 
the European Regulation on Medical Devices 2017 /745 (M DR) and with the ethical principles laid down 
in the Declaration of Helsinki. 
The investigators will perform the study in accordance with this CIP, will obtain patients' consent and 
will report any adverse events. Collection, recording, and reporting of data will be accurate and will 
ensure the privacy, health, and welfare of participating patients during and after the study. 
The EC/IRB and the CA/RA (if applicable) will receive the Annual Safety Report (ASR) and be notified 
about investigation stop/end in agreement with local requirements. 
8 STUDY DEVICE ACCOUNTABILITY 
8.1 
LABELLING 
There is no specific labelling for this study: investigators will use the Alveogyl jars they have bought for 
their current needs (commercial use, with commercial labelling). Indeed, Alveogyl is commercialized in 
India and in France, and is used in its indication in this study. 
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8.2 
STORAGE CONDITIONS 
The study device is used as intended in the IFU. 
Device storage is according to the IFU (Annex 1) 
8.3 
SUPPLY (AND RE-SUPPLY) 
Sponsor: SE PTO DO NT 
The investigators have Alveogyl in their stock. No dedicated Alveogyl will be delivered for the clinical 
study. if there is a need for re-supply, the shipment is as per standard commercial procedures. 
The batch numbers used for each patient will be recorded in the CRF. 
8.4 
RETURN, ANALYSIS OR DESTRUCTION OF THE STUDY DEVICE 
After the study end, the remaining products are kept by the investigators and will be used by the 
investigators for the patients that need to be treated by Alveogyl in the commercial use. 
In case of device deficiencies, including malfunction, usability issues, or inadequacy in the information 
supplied by the manufacturer including labelling, the devices will be returned to the Sponsor for analysis. 
9 QUALITY ASSURANCE AND CONTROL 
9.1 
DATA HANDLING AND RECORD KEEPING 
9.1.1 
Case report forms 
The Investigator or designee will be responsible for completing, in a timely manner, a (paper or 
electronic) Case Report Form (CRF) for each patient enrolled in thi s study. 
Note: The person(s) authorized by the Pl to enter the data in the CRF must be listed on the delegation 
log. 
Specifi c instructions and training for its use and completion will be provided by the CRO or by Septodont 
to the study staff. CRFs are to be completed as information becomes available. 
The Investigator will sign and date the indicated places on the CRF. This will confirm that a thorough 
inspection of the audited data therein has been made and will thereby certify the content of the forms. 
9.1.2 
Specification of source data and source documents 
Source data must include the original documents relating to the investigation, as well as the medical 
treatment and medical history of the patient. 
Source data for this study wil l include the original patient records maintained by the study sites, as per 
their ongoing standard of care. This could include details on the patient's medical history, any imaging 
data (i.e., radiography), and procedural records for any prior surgeries or interventions. 
Source data also include index procedure report, visit dates, informed consent forms, SAEs, SADEs, 
USADEs, concomitant medication and results of relevant examinations. 
Original source data wi ll be kept at the site and made available during site monitoring or audit visits. 
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9.1.3 
Record keeping of essential clinical investigation documents 
All CRF information, study records, reports and source documents that support the CRF must be 
retained in the files of the investigator according to national requirements following notification by the 
Sponsor or designee that all investigations have been completed, and will further be retained in 
accordance with local and international guidelines as identified in the Clinical Trial Agreement (CTA). 
This documentation must be accessible upon request by international regulatory authorities or the 
Sponsor (or designee). The Sponsor or designee must approve archiving or transfer of the 
documentation for relocation purpose of premises, in writing, prior to the actual file transfer. The 
investigator must notify the Sponsor, in writing, of transfer location, duration, and the procedure for 
accessing study documentation. The investigator must contact the Sponsor, or designee, before the 
destruction of any records and reports pertaining to the study to ensure they no longer need to be 
retained. 
If the investigator retires, relocates, or for other reasons withdraws from assuming primary 
responsibility for keeping the study records, custody per written notice must be submitted to the 
Sponsor, or designee, indicating the name and address of the person accepting primary responsibility. 
The EC/IRB must be notified in writing of the name and address of the new custodian. 
In France, patients' data must be kept up to two years after the last study results publication or, if there 
is no publication intended, up to the final study report signature. Investigators personal data will not be 
kept beyond 15 years after the end of the study. All these information will then be archived in paper or 
electronically (for more information, see §9.2.4 - Archiving). 
9.2 
DATA MANAGEMENT 
9.2.1 
Data management system 
Clinical data management will be performed in accordance with data cleaning procedures. 
If data are recorded in an e-CRF, appropriate computer edit programs will be run to verify the accuracy 
of the database. The investigator will be queried on incomplete, inconsistent or missing data. 
If paper CRF are used, Septodont's designee will directly collect the completed and signed CRF from the 
investigational sites. Septodont's designee will enter the data collected in a data sheet and send the data 
to the statistician for analysis. 
9.2.2 
Data security, access and back-up 
If data are recorded in an e-CRF, access to the e-CRF is granted by the CRO to Investigators and 
designees after completion of a user access form. The access is limited by a login and only authorized 
users can access the e-CRF. Upon the study start-up visit to the investigational site, access to the e-CRF 
is provided. 
If paper CRF are used, paper CRF will be provided to the investigational sites upon the study start-up 
visit to the investigational site. Septodont's designee will verify that access to completed CRF is secured 
(storage in a secured place with limited access). 
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9.2.3 
Electronic and central data validation 
Study data are entered in a paper CRF or an e-CRF by the investigational site team. The investigators 
validate the data entered by signing all required pages (e.g., patient inclusion, adverse events). All data 
entered in the CRF are monitored by a trained and qualified Clinical Research Associates (CRAs). 
9.2.4 
Archiving 
As specified in the norm ISO14155, the sponsor and principal investigator shall maintain the clinical 
investigation documents. They shall take measures to prevent accidental or premature destruction of 
these documents. 
Clinical investigation documents include but are not limited to CIP, patients informed consent form and 
clinical investigation report. 
All the documents of the investigation must be archived for a minimum of 15 years after regular or 
premature termination of the investigation by the Sponsor and each investigation sites. 
9.3 
MONITORING 
Monitoring the clinical study at the investigational site through trained and qualified CRAs is the 
responsibility of the CRO in India and of the Sponsor in France. 
Monitoring visits will be performed according to the monitoring plan. During on-site monitoring, the 
Informed Consent Forms will be checked and a sample of clinical data will be verified compared to CRF 
data. Patient confidentiality will be maintained at all time. Emphasis will be on the complete reporting 
by the study staff of AEs and SAEs. 
Each clinical site will be visited during the study to ensure a high degree of data quality. These site 
monitoring visits will be conducted to verify that the data are authentic, accurate and complete, that 
patients' safety and rights are protected, that the study is conducted according to this current CIP, and 
that any other study agreements, GCP and all applicable regulatory requirements are met. The 
investigator and the head of the medical institution (where applicable) agree to allow the CRA direct 
access to all relevant documents. It is important that the investigator and the study staff are available 
during the monitoring visit and possible audits and that sufficient time is devoted to the process. 
Findings from the review and source documents will be discussed with the investigator. 
Remote site monitoring may also be performed to ensure complete quality study data and patient 
adherence to the protocol. On a regular basis, the monitoring organization will contact each site to 
discuss the progress of the study with respect to patient enrolment, timely attendance of patients to 
their follow-up visits and other relevant study aspects such as data query resolution. 
Each participating centre will receive a close-out visit to resolve any outstanding issues and to perform 
the final source data verification. 
9.4 
AUDITS AND INSPECTIONS 
To ensure compliance with GCP and regulatory requirements, a member of the Sponsor's (or a 
designated CRO's) quality assurance unit, may arrange to conduct an audit to assess the performance 
of the study at the investigational site and of the study documents originating there. The investigator 
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agrees to cooperate with the Sponsor and/or its designee in the conduct of these audits and provide 
access to medical records and other relevant documentation (source data/documents), as required. The 
investigator/institution will be informed of the audit outcome. 
Regulatory authorities worldwide (EC/IRB and CA/RA) may inspect the investigational site during and 
after the study. The investigator should contact the sponsor immediately as soon as notified of this 
inspection, and must cooperate with the regulatory authority inspections as required. 
9.5 
SUBJECT PRIVACY, CONFIDENTIALITY, DATA PROTECTION 
The Sponsor and the Pl affirm and uphold the principle of the Patients' right to privacy and that they 
shall comply with applicable privacy laws. Especially, anonymity of the patients shall be guaranteed 
when presenting the data at scientific meetings or publishing them in scientific journals. 
Patient confidentiality wi ll be maintained throughout the study in a way that assures that data can 
always be tracked back to the source data. For this purpose, a unique subject identification code will be 
used for this study. 
Individual patient medical information obtained as a result of this study is considered confidential and 
disclosure to third parties is prohibited. 
For data verification purposes, authorised representatives of the Sponsor, the CA/RA or the EC/IRB may 
require direct access to parts of the medical records relevant to the study, including patient's medical 
history. 
9.6 
STORAGE OF BIOLOGICAL MATERIAL AND RELATED HEALTH DATA 
N/A. No biological material is used for this clinical study. 
10 PUBLICATION AND DISSEMINATION POLICY 
Results of this study wi ll not be submitted for presentation or publication without the prior written 
permission of the Sponsor. 
The publication and communication rights can be found in the Clinical Trial Agreement negotiated with 
each study centre: neither the complete nor any part of the study results carried out under this CIP, nor 
any of the information provided by the Sponsor for the purposes of performing the study, will be 
published or passed on to any third party without the consent of the study Sponsor. 
Any written or oral communication of the study results has to receive the preliminary agreement of the 
Coordinating Investigator and of the Sponsor. 
At the study termination, a manuscript may be prepared for publication in a peer-reviewed scientific 
journal. Publication of the main results from any single centre will require the prior written approval of 
the Sponsor. 
The study investigators may publish or communicate results, with the prior written approval of the 
Sponsor and the Coordinating Investigator. They must provide the Sponsor and Coordinating 
Investigator a copy of any ora l presentation or written publication at least 30 days in advance of the 
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submission for publication. The Sponsor and Coordinating Investigator have the right to comment on 
the appropriateness of the data analysis and presentation. 
11 FUNDING AND SUPPORT 
11.1 FUNDING 
The study is sponsored by Septodont, without external funding. 
11.2 OTHER SUPPORT 
N/A. 
12 INSURANCE 
Patients who participate in this clinical study will be insured against any injury related to the study, 
according to local regulation requirements. 
Insurance will be provided by the Sponsor. A copy of the certificate is filed in each investigation site file 
and the sponsor file. 
Note: In France, this clinical study is considered as a Post-Market Clinical Follow-up study with non-
invasive and non-cumbersome additional procedures. Therefore, no specific insurance is required. 
13 MEDICAL TREATMENT/ COMPENSATION OF THE PATIENT 
At the visit 1- Day 0, the patient is consulting his/her dentist in a context of post-extraction dry socket: 
this medical consultation and the treatment by Alveogyl, are not supported by the sponsor; Septodont 
is only supporting the data collection. The patient transportation for this visit is supported only in India 
(a lump sum of 1000 Indian rupees). 
At visit 2 - Day 7, the visit cost is supported by Septodont if no medical consultation is specifica lly 
schedu led for the dental/medical healthcare of the patient. However, if the patient needs to come for 
a dental/medical healthcare reason at this visit, the medical consultation and any treatment done to 
the patient won't be supported by Septodont. Septodont is only supporting the data collection. 
Septodont is also supporting transportation fee reimbursement for this visit 2 (a lump sum of 50 euros 
in France, and a lump sum of 1000 Indian rupees in India). 
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14 REFERENCES 
[1] 
C. C. Burgoyne, J. A. Giglio, S. E. Reese, A. P. Sima, et D. M. Laskin,« The efficacy of a topical 
anesthetic gel in the relief of pain associated with localized alveolar osteitis », J. Oral Maxillofac. Surg. 
Off 
J. 
Am. Assoc. 
Oral Maxillofac. Surg., 
vo l. 
68, 
n° 1, 
p. 
144-148, janv. 2010, doi: 
10.1016/j.joms.2009.06.033. 
[2] 
C. L. Cardoso, M. T. V. Rodrigues, 0. Ferreira Junior, G. P. Garlet, et P. S. P. de Carvalho,« Clinical 
concepts of dry socket», J. Oral Maxillofac. Surg. Off J. Am. Assoc. Oral Maxillofac. Surg., vol. 68, n° 8, 
p. 1922-1932, ao0t 2010, doi: 10.1016/j.joms.2009.09.085. 
[3] 
D. C. Bowe, S. Rogers, et L. F. A. Stassen, « The management of dry socket/a lveolar osteitis », J. 
Ir. Dent. Assoc., vo l. 57, n° 6, p. 305-310, janv. 2011. 
[4] 
I. R. Blum, « Contemporary views on dry socket (alveolar osteitis): a clinical appraisal of 
standardization, aetiopathogenesis and management: a critical review», Int. J. Oral Maxillofac. Surg., 
vo l. 31, n° 3, p. 309-317, juin 2002, doi: 10.1054/ijom.2002.0263. 
[5] 
M. A. Saghiri, A. Asatourian, et N. Sheibani, « Angiogenesis and the prevention of alveolar 
osteitis: a review study», J. Korean Assoc. Oral Maxillofac. Surg., vol. 44, n° 3, p. 93-102, juin 2018, doi: 
10.5125/jkaoms.2018.44.3.93. 
[6] 
M. Taberner-Vallverdu, M. Nazir, M.A. Sanchez-Garces, et C. Gay-Escoda, « Efficacy of different 
methods used for dry socket management: A systematic review», Med. Oral Pata/. Oral Cirugia Buco!, 
vo l. 20, n° 5, p. e633-639, sept. 2015, doi: 10.4317/medoral.20589. 
[7] 
HAS, « Liste des echelles acceptees pour mesurer la douleur ». 
[8] 
F. Garala, G. Gilligan, R. Panico, N. Leonard i, et E. Piemonte, « Clinical management of alveolar 
osteitis. A systematic review», Med. Oral Pata/. Oral Cirugia Buco!, vol. 26, n° 6, p. e691-e702, nov. 
2021, doi: 10.4317 /medoral.24256. 
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APPENDICES 
Annex 1. 
Alveogyl - Instructions for use 
This Instructi on for use is in commercial batches released up to May 2022. 
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CON Fl DENTIAL 
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This Instruction for use is in commercial batches released from May 2022. 
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Annex 2. 
Alveogyl - Risk analysis 
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Other essential study documents (e.g., investigators list, Informed consent forms, CRF ... ) are available 
elsewhere. 
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