Retrospective Clinical Evaluation of Nano-hybrid-composite Denture Teeth SR Phonares II
Phase: NA
Conditions: Edentulous Mouth, Dental Prosthesis Failure
Sponsor: Ivoclar Vivadent AG

 
Retrospective clinical evaluation of nano-hybrid-
composite denture teeth SR Phonares II 
Type of investigation: 
Clinical investigation concerning medical devices 
Categorisation: 
Category according to Art 6 ClinO-MD: A1 
Registration: 
Registry at ClinicalTrials.gov of the U.S. National Library of Medicine 
(http://www.clinicaltrials.gov) 
The trial additionally registers in the supplementary federal database 
(Portal 
for 
clinical 
trials 
in 
Switzerland 
- 
SNCTP, 
https://www.kofam.ch/en/snctp-portal/) with its submission on 
BASEC.  
Furthermore, as soon as the new electronic system EUDAMED2 is 
operational, the clinical investigation will be retrospectively 
registered, if required. 
Identifier: 
LL 5267725 
Principal Investigator and 
Sponsor, or Sponsor-
Investigator: 
Principal Investigator (PI): 
Dr. med. dent. Ronny Watzke 
Bendererstrasse 2 
9494 Schaan 
Fürstentum Liechtenstein 
Tel.: 
 
Mail: 
 
Sponsor: 
Ivoclar Vivadent AG 
Bendererstrasse 2 
9494 Schaan 
Fürstentum Liechtenstein 
Sponsor representative (if the 
Sponsor is not located in 
Switzerland) 
Patrik Oehri 
Senior Director Corporate Quality Management/PRRC 
Tel.: 
 
Mail: 
 
Medical Device: 
SR Phonares II (Ivoclar Vivadent AG) 
Article 
UDI 
SR Phonares II Ant. 6er OS71 A2 
DIVO6448651 
SR Phonares II Ant. 6er OS71 A3 
DIVO6448661 
SR Phonares II Ant. 6er OS72 A3 
DIVO6448861 
SR Phonares II Ant. 6er OB71 A3 
DIVO6450461 
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LL 5267725  
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SR Phonares II Ant. 6er OB72 A3 
DIVO6450661 
SR Phonares II Ant. 6er OB73 A3 
DIVO6450861 
SR Phonares II Ant. 6er OB73 A3.5 
DIVO6450871 
SR Phonares II Ant. 6er UL50 A2 
DIVO6451651 
SR Phonares II Ant. 6er UL51 A3 
DIVO6451861 
SR Phonares II Ant. 6er UL51 A3.5 
DIVO6451871 
SR Phonares II Ant. 6er UL52 A3 
DIVO6452061 
SR Phonares II Ant. 6er UL53 A3 
DIVO6452261 
SR Phonares II Typ 8er ONU3 A3 
DIVO6453661 
SR Phonares II Typ 8er ONU5 A3 
DIVO6453861 
SR Phonares II Typ 8er ONU5 A3.5 
DIVO6453871 
SR Phonares II Typ 8er ONU6 A3 
DIVO6454061 
SR Phonares II Typ 8er UNL3 A2 
DIVO6454251 
SR Phonares II Typ 8er UNL5 A3 
DIVO6454461 
SR Phonares II Typ 8er UNL5 A3.5 
DIVO6454471 
Version and Date: 
Version 2.0, 19.09.2022 
CONFIDENTIAL 
The information contained in this document is confidential and the property of the Ivoclar Vivadent AG. 
The information may not - in full or in part - be transmitted, reproduced, published, or disclosed to others 
than the applicable Competent Ethics Committee(s) and Regulatory Authority(ies) without prior written 
authorisation from the Sponsor except to the extent necessary to obtain informed consent from those 
who will participate in the investigation. 

Signature Page(s) 
ID number of the 
LL 5267725 
investigation: 
Registry at ClinicalTrials.gov of the U.S. National Library of 
Medicine (http://www.clinicaltrials.gov): 
Title: 
The trial additionally registers in the supplementary federal 
database (Portal for clinical trials in Switzerland - SNCTP, 
https://www.kofam.ch/en/snctp-portal/) with its submission on 
BASEC. 
Furthermore, as soon as the new electronic system EUDAMED2 
is operational, the clinical investigation will be retrospectively 
registered, if required. 
Retrospective clinical evaluation of 
nano-hybrid-composite 
denture teeth SR Phonares II 
The Sponsor, the Principal lnvestigator and the Statistician have approved the CIP version 1.0 (dated 
23.08.2022) and confirm hereby to conduct the investigation according to the CIP, the current version 
of the World Medical Association Declaration of Helsinki, ISO14155 norm, ICH-GCP as far as applicable, 
and the local legally applicable requirements. 
Sponsor-Representative: 
Patrik Oehri 
Place/Date 
Signature 
Principal lnvestigator: 
Dr. med. dent. Ronny Watzke 
r 
Place/Date 
Signature 
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1.  SYNOPSIS 
Sponsor / Sponsor-
Investigator 
Ivoclar Vivadent AG 
Title: 
Retrospective clinical evaluation of nano-hybrid-composite denture teeth SR 
Phonares II 
Short title / 
Investigation ID: 
Retrospective clinical evaluation of SR Phonares II 
Investigation ID: LL 5267725   
Clinical Investigation 
Plan, version and 
date: 
Version 2.0, 19.09.2022 
Registration: 
Registry at ClinicalTrials.gov of the U.S. National Library of Medicine 
(http://www.clinicaltrials.gov):  
The trial additionally registers in the supplementary federal database (Portal 
for clinical trials in Switzerland - SNCTP, https://www.kofam.ch/en/snctp-
portal/) with its submission on BASEC.  
Furthermore, as soon as the new electronic system EUDAMED2 is operational, 
the clinical investigation will be retrospectively registered, if required. 
Category and its 
rationale: 
Category A1 
The medical device has conformity marking and will be used according to its 
instruction for use. The subjects are not subjected to any additional invasive or 
stressful procedures compared with those applied under normal conditions of 
use of the product. 

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Name of the MD, 
Unique Device 
Identification (UDI), 
name of the 
manufacturer 
SR Phonares II 
Article  
UDI 
SR Phonares II Ant. 6er OS71 A2 
DIVO6448651 
SR Phonares II Ant. 6er OS71 A3 
DIVO6448661 
SR Phonares II Ant. 6er OS72 A3 
DIVO6448861 
SR Phonares II Ant. 6er OB71 A3 
DIVO6450461 
SR Phonares II Ant. 6er OB72 A3 
DIVO6450661 
SR Phonares II Ant. 6er OB73 A3 
DIVO6450861 
SR Phonares II Ant. 6er OB73 A3.5 
DIVO6450871 
SR Phonares II Ant. 6er UL50 A2 
DIVO6451651 
SR Phonares II Ant. 6er UL51 A3 
DIVO6451861 
SR Phonares II Ant. 6er UL51 A3.5 
DIVO6451871 
SR Phonares II Ant. 6er UL52 A3 
DIVO6452061 
SR Phonares II Ant. 6er UL53 A3 
DIVO6452261 
SR Phonares II Typ 8er ONU3 A3 
DIVO6453661 
SR Phonares II Typ 8er ONU5 A3 
DIVO6453861 
SR Phonares II Typ 8er ONU5 A3.5 
DIVO6453871 
SR Phonares II Typ 8er ONU6 A3 
DIVO6454061 
SR Phonares II Typ 8er UNL3 A2 
DIVO6454251 
SR Phonares II Typ 8er UNL5 A3 
DIVO6454461 
SR Phonares II Typ 8er UNL5 A3.5 
DIVO6454471 
Ivoclar Vivadent AG 
Benderer Strasse 2 
9494 Schaan 
Stage of 
development: 
Post-market stage with CE marking 
Background and 
rationale: 
This retrospective study investigates the longevity of dentures with SR 
Phonares II teeth after a wearing period of more than 10 years. 
Objective(s): 
The primary objective is to assess the survival rate of dentures with SR 
Phonares II teeth after more than 10 years. The secondary objectives asses 
the quality of the dentures concerning aesthetic, functional and biological 
properties. 
Outcome(s): 
The primary outcome of the study is the survival rate of the dentures with the 
tested denture teeth. The secondary outcomes are all linked to the quality of 
the materials used (surface lustre, staining, plaque accumulation, color 
match, aesthetic anatomical form, fracture, marginal adaptation, occlusal 
contour, wear patients view, integrity of adjacent natural teeth, adjacent 
mucosa, oral health). 
Design: 
Retrospective evaluation 

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Inclusion / exclusion 
criteria: 
Subjects fulfilling all inclusion criteria are eligible for the investigation: informed 
consent signed and understood by the subject, partial or full denture with SR 
Phonares II teeth, dentures delivered in the internal clinic between August 
2010 and August 2012, to be able to visit the internal clinic (Exception: Patients 
with limited mobility are also included if another person can carry the dentures 
to the internal clinic of Ivoclar Vivadent AG for the examination.). 
The presence of any of the following exclusion criteria will lead to the 
exclusion of the subject: patient does not wear the dentures regularly, health 
status (physical and mental) does not allow participation. 
Measurements and 
procedures: 
The intraoral situation will be examined similar to a standard dental 
examination. The dentures are then removed, cleaned and examined 
extraoral. Pictures and an impression of the dentures are taken. 
Intervention: 
The examinations do not differ from standard dental examinations.  
Impressions of the back teeth of the dentures are taken extraoral and stone 
casts are poured. They are used for analysis of wear and microscopical 
analysis.  
Control intervention 
(if applicable): 
n.a.
Number of subjects 
with rationale: 
22 patients that were supplied with dentures with SR Phonares II teeth (in total 
43 dentures) in the internal clinic of Ivoclar Vivadent AG between August 2010 
and August 2012. 
Duration of the 
investigation: 
6 months 
Investigation 
schedule: 
October 2022 First- subject –In (planned) 
March 2023 Last- subject –Out (planned) 
Investigator(s): 
Dr. med. dent. Ronny Watzke 
Bendererstrasse 2 
9494 Schaan 
Fürstentum Liechtenstein 
Tel.: 
 
Mail: 
 
Investigational 
Site(s): 
This is a single centre study. 
R&D Clinic 
Ivoclar Vivadent AG 
Bendererstrasse 2 
9494 Schaan 
Fürstentum Liechtenstein 
Statistical 
considerations: 
Since the study is retrospective with a small cohort and no control group, 
mainly descriptive statistical analysis will be performed. The obtained data, 
especially the survival rate will be discussed and compared with data from 
the literature. A minimal sample size of 41 dentures was calculated with 
absolute error (precision of 10% and and standard normal variate of 5% (type 
1 error)).  
Compliance 
statement: 
This investigation will be conducted in compliance with the CIP, the current 
version of the Declaration of Helsinki, ISO14155, ICH-GCP (as far as 
applicable) as well as all national legal and regulatory requirements.  

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2.  ABBREVIATIONS 
AE 
Adverse Event  
ADE 
Adverse Device Effect 
ASADE 
Anticipated Serious Adverse Device Effect 
ASR 
Annual Safety Report 
CA 
Competent Authority (e.g. Swissmedic) 
CEC 
Competent Ethics Committee 
CIP 
Clinical investigation plan 
ClinO 
Ordinance on Clinical Trials in Human Research (in German KlinV, in French Oclin, 
in Italian OSRUm) 
ClinO-MD 
Ordinance on Clinical Trials with Medical Devices (in German: KlinV-Mep, in French: 
Oclin-Dim, in Italian: OSRUm-Dmed) 
CRF 
Case Report Form (pCRF paper CRF; eCRF electronic CRF) 
DD 
Device Deficiency 
DMC / DSMC 
Data Monitoring Committee, Data Safety Monitoring Committee 
Ho 
Null hypothesis 
H1 
Alternative hypothesis 
HRA 
Federal Act on Research involving Human Beings (in German: HFG, in French: 
LRH, in Italian: LRUm) 
IB 
Investigator’s Brochure 
ICF 
Informed Consent Form 
ICH-GCP 
International Council for Harmonisation – guidelines of Good Clinical Practice 
IFU 
Instruction For Use 
ISF 
Investigator Site File 
ISO 
International Organisation for Standardisation 
ITT 
Intention to treat 
MedDO 
Medical Devices Ordinance (in German: MepV, in French: Odim, in Italian: Odmed) 
MD 
Medical Device  
MDR 
Medical Device Regulation (EU) 2017/745 of 5 April 2017 
PI 
Principal Investigator 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification  
SNCTP 
Swiss National Clinical Trials Portal 
SOP 
Standard Operating Procedure 
USADE 
Unanticipated Serious Adverse Device Effect 

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3. SUMMARY OF THE REVISION HISTORY IN CASE OF AMENDMENTS
Version Nr, 
Version Date 
Chapter 
Description of change 
Reason for the change 
4. INVESTIGATION SCHEDULE
Investigation Periods 
Patient 
information 
Consent (ICF) 
Recall 
Visit 
0 
1 
1 
Time (day) 
-3
0 
0 
Patient Information by 
phone 
x 
Patient consent (ICF) 
x 
Primary Variables 
x 
Secondary Variables 
x 
Dental radiograph 
(x) 
Adverse events 
x 
Device Deficiencies 
x 
(x) dental radiographs of a single tooth or dental implant will only be taken if necessary for medical
reasons independent of the clinical trial.