Graftless Closed Sinus Tenting Using Dental Implants After Densah Burs Osteotomy Versus Conventional Osteotomy in Localized Sinus Pneumatization: a Randomized Clinical Trial
Phase: NA
Conditions: Edentulous Alveolar Ridge
Sponsor: Cairo University

Graftless Closed Sinus Tenting Using Dental Implants 
After Densah Burs Osteotomy Versus Conventional 
Osteotomy in Localized Sinus Pneumatization: a 
Randomized Clinical Trial 
   
 
 
Thesis Protocol Submitted for Partial Fulfillment of the Requirements for 
Master’s Degree In Oral & Maxillofacial Surgery   
Faculty of Oral & Dental Medicine - Cairo University 
 
By 
Basma Mohammed Shaheen 
B.D.S Oral & Dental Medicine, MIU Uni. 2016, Egypt  
 
(26th October, 2021) 
 
                                                            Code: OMFS  3-3-5 
 
 
Supervisors’ signature 
Head of department’s signature 
1-Prof. Dr. Sameh Tarek 
                                           
 
 
2-Dr. Mohammed  Omara 
                              
 
 
 
 
 

Protocol checklist 
Section and topic 
Item 
no. 
Checked item 
Reported 
on page 
No. 
Reviewer’s 
check 
I. Administrative 
information 
1 
Title 
 5 
 
2 
Protocol registration 
5 
 
3 
Protocol version 
5 
 
4 
Funding 
5 
 
5 
Roles and 
responsibilities 
5-6 
 
 
II. Introduction 
 
 
 
A) Background 
and Rationale 
6 a 
Research question  
6 
 
Statement of the 
problem 
6 
 
Rationale for 
carrying out the trial 
6 
 
Review of literature 
6-7 
 
6 b 
Choice of 
comparators 
7 
 
B) Objectives 
7 
Aim of the study 
7 
 
Hypothesis 
7 
 
Primary and 
secondary objectives 
7-8 
 
C) Trial design 
8 
Trial design 
8 
 
 
III. Methods 
 
 
 
A) Participants, 
interventions & 
outcomes 
9 
Study setting 
9 
 
10 
Eligibility criteria 
9 
 
11 
Interventions 
9-10-11 
 
12 
Outcomes 
11 
 
13 
Participant timeline 
12 
 

14 
Sample size 
13 
 
15 
Recruitment 
13 
 
B) Assignment of 
interventions 
16 
Allocation 
13 
 
16 a 
Random sequence 
generation 
(Randomization) 
13 
 
16 b 
Allocation 
concealment 
mechanism 
13 
 
16 c 
Implementation 
13 
 
17 
Blinding (masking) 
13 
 
C) Data collection, 
management, and 
analysis 
18 
Data collection 
methods 
14 
 
19 
Data management 
14 
 
20 
Statistical methods 
15 
 
D) Monitoring 
21 
Data monitoring 
15 
 
22 
Harms 
15 
 
23 
Auditing 
15 
 
 
IV. Ethics and 
dissemination 
24 
Research ethics 
approval 
15 
 
25 
Protocol 
amendments 
15 
 
26 
Informed Consent  
16 
 
27 
Confidentiality 
16 
 
28 
Declaration of 
interests 
16 
 
29 
Access to data 
16 
 
30 
Ancillary and post-
trial care 
16 
 
31 
Dissemination policy 
16 
 
 
V. Appendices 
 
32 
Informed consent 
materials 
16-17-18-
19 
 

Evidence based committee (Reviewers) 
Name 
I. Administrative information; 
1. Title: 
Signature 
Date 
Assessment of bone gain after closed sinus lifting using densa bur 
versus conventional technique in isolated sinus pneumatization: a 

randomized clinical trial. 
2. Protocol Registration:  
This study will be registered at Clinicaltrials.gov by ID number NCT……….  
 
3. Protocol version:  
 2019, Version: 1  
 
4. Funding:  
The trial is totally self-funded whether on a financial or a non-financial basis. Equipment 
units and some consumables are provided by Department of Oral and Maxillofacial 
surgery, Faculty of Dentistry Cairo University. 
 
5. Roles and responsibilities: 
 
 1. Prof. Dr. Sameh Tarek 
• 
Professor of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University.  
• 
Main Supervisor.  
• 
Responsible for auditing and main surgical supervision.  
 
2. Dr. Mohammed Omara  
• 
Lecturer of Oral and Maxillofacial Surgery- Cairo University.  
• 
Assistant supervisor  
• 
Responsible for randomization, allocation, outcome assessment, and supervising all surgical 
procedures.  
 
3. Basma Mohammed Shaheen  
• 
Researcher  
• 
Responsible for recruitment and taking participant’s consent, baseline data and outcome 
data collection, and performing clinical part of the trial.  
• 
Thesis writing and final report of the research  
 
Responsibilities: 
Investigator: conducts the research and the operations needed. 
Main supervisor: supervises the whole process of the research. 
Assistant Supervisor: monitors the research progress (in details) and supervises 
the operations on patients. 

 
 
II. Introduction:  
Research question:  
Will the use of densa bur lead to better bone gain around implant than conventional 
closed sinus lift in isolated pneumatized sinus? 
Statement of the problem: 
Isolated sinus pneumatization after single tooth extraction indicate sinus lifting for proper implant 
placement so the conventional way of using osteotomes to elevate the sinus is annoying to patient and 
also doesn’t give the needed amount of bone around the implant. 
Introducing new intervention of densa bur (reverse condensing oseodensification)helps increase bone 
gain around implant and decrease the  patient discomfort  
Rationale for conducting the research: 
The formed bone  around implant after using oseodensifying burs compared to control 
group of conventional osteotomes 
 
Review of literature: 
 The rehabilitation of the edentulous posterior maxilla using osseointegrated implants is often 
challenging due alveolar bone resorption, low bone density and maxillary sinus pneumatization. 
Maxillary sinus lift is one of the most common surgical techniques used for increasing the available 
bone volume to place implants and restore function and esthetics transcrestal approach can be 
successfully adopted when residual bone height is at least 5 mm. Osteotome sinus floor elevation was 
1st introduced by Summers (5,6)1994, and proved to be less invasive, more conservative, less time 
consuming, and reduces postoperative discomfort to the patient. Moreover, this technique was found 
to yield predictable results, with success rates of at least 95%.  
Osseo densification is a new surgical technique of biomechanical bone preparation performed for 
dental implant placement where bone is compacted and auto grafted into open marrow spaces and 
osteotomy site walls in outwardly expanding directions. It was reported that Osseo densification 
increases the bone-implant contact, bone density, and primary stability. Moreover, The insertion 
torque peak is directly related to implant primary stability and host bone density. Furthermore, Ottoni 
et al. showed a reduction in failure rate of 20% in single-tooth implant restoration for every 9.8 N cm of 
torque increased.  
The objective of this study was to evaluate crestal sinus elevation using oseodensification versus 
osteotomy clinically and radiographically in terms of marginal bone loss, primary and secondary 
stability and bone gain around the implant. 
 
Explanation for choice of comparators:  
The main disadvantage of use of osteotomes is patient discomfort and affected primary 
stability and bone gain in comparison to oseodensifycation. 

7. Objectives: 
The aim of study to compare the quantity of bone gained in use of densa bur 
(oseodensification) versus conventional closed sinus lift used as control group 
 
Hypothesis:  
Null hypothesis:  this study is alternative hypothesis research based on that one 
technique will be more efficient and effective than the other. In our case, the bone gained  
after use of densa bur  will be more and better quality than amount gained after use of 
osteotomes  and this technique will be compared to  the control group  
Primary objective: 
Evaluating amount of bone gain in both techniques  
 
PICO 
 
(P): isolated sinus pneumatization in extracted upper Molar ( missing tooth sinus 
pneumatization)  
I: densa bur in closed sinus lift ( reverse cutting condensing bur)   
C:conventional closed sinus lift ( osteotomes in closed lifting ) 
O1: bone gain (increase bone volume ) (apical bone fill)  by x-ray subtraction 
O2: primary stability (mechanical oseintegration) by ostell 
 
 
 
8. Trial design: 
 
• 
Randomized Controlled clinical trial.  
• 
Parallel group study.  
• 
Allocation Ratio 1: 1.  
 
III. Methods 
A) Participants, interventions & outcomes 
 
9. Study settings: 
Study is to be conducted in the Oral and Maxillofacial Department, Faculty of Dentistry, 
Cairo University.  
 

 
10. Eligibility criteria: 
Inclusion criteria: 
                No inflamed sinus 
               Min height 5-6 mm 
                Medical free 
              Patients who have given their consent for this trial. 
 Both genders males and females will be included. 
Exclusion criteria: 
• Remaining ridges<5mm 
• 
Patients should not have taken drugs, especially bisphosphonates or drugs altering bone 
metabolism, within 2 months before the inclusion in the study. 
•  Subjected to irradiation in the head and neck area less than 1 year before 
implantation. 
• 
Patients having history of allergy to any drugs. 
• 
Patients who have a history of any concomitant major known medical problem and/or 
ongoing pharmacologic treatments 
• Untreated periodontitis. 
• Poor oral hygiene and motivation. 
• Uncontrolled diabetes. 
• Pregnant or nursing. 
• Substance abuse. 
• Psychiatric problems or unrealistic expectations. 
• Severe bruxism or clenching. 
• Immunosuppressed or immunocompromised. 
• Treated or under treatment with intravenous amino-bisphosphonates. 
• Active infection or severe inflammation in the area intended for implant 
placement. 
• Unable to open mouth sufficiently to accommodate the surgical tooling. 

• Patients participating in other studies, if the present protocol could not be properly 
followed. 
• Referred only for implant placement or unable to attend a 5-year follow-up. 
11. Interventions 
All patients involved in this study will be divided in to two different groups, one group will 
receive densa bur sinus elevation and the second group is the control conventional 
sinus elevation  
 
Clinical evaluation: 
A through medical and dental history followed by clinical examination was carried out for all 
patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion 
criteria prior to further investigations.  
A pre-operative digital panoramic image and CBCT will be done to evaluate the height and 
the width of the intended sinus elevation  
 
Intra operative procedures for both groups: 
This clinical report describes two different groups Following the protocol of The Oxford 
Dental College Hospital, Bomannahalli. 
In all groups : 
Infiltration anesthesia or nerve block according the socket were administered using mepivacaine HCl 
(2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). 
Injection to control pain and bleeding for hemostasis. Scrubbing and draping of the patient was carried 
out in a standard fashion using betadine, traumatic extraction will then be done. 
 
• In first  group: use of densa bur for closed sinus lift (oseodensification) and 
auto grafting  
   
• in second groups : use of osteotomes in closed sinus lifting  
 
• After 3 then 6 months post-operative CT scans will be done to evaluate the 
bone density, apical bone gain will be measured  
 
• in both group:  
Follow up  
 
Patients will be evaluated for primary stability at same day of operation  and then 
radiographically after 3 then 6 months and weekly for first month for healing .  
.  
 

 
12. Outcomes: 
TYPES OF 
OUTCOME 
OUT COME 
MEASURE DEVICE 
MEASURE UNIT 
 
 
PRIMARY      
1RY 
Bone gain 
Cbct  
 
Radiographic 
subtraction  
 
           
2ry 
outcome 
Primary stability  
ostell  
N cm torque 
 
 
 
 
 
13.Participant 
timeline 
 
 
 
Study period  
 
  
  
  
Enrollment  
(T0)  
  
  
  
Allocation  
  
Intervention  
Follow up   
    
  
     Study steps  
  
  
 Operation day    
  
  
3 months after 
operation day  
(T1)  
  
  
Enrollment:  
Eligability. 
screening Informed 
consent  
 
    
 
-
-
-  
  
----  
  
  
  
  
  
Pre-operative 
documentation  
    
   ✓  
  
  
  
  
Allocation  
 -
---  
  
        
      ✓      
  
-----  
  
  
  
  
  
Generation 
sequence  
  
 
✓    
-------  
-----  
-------  
  

Surgical exposure 
of the operated site  
------  
   ------  
 
 
            ✓ 
  
  
Intervention  
 
  
  
 
           ✓  
  
  
Comparator  
 
------  
-------  
 
 ✓  
  
Post-operative 
documentation  
  
  
  
 
              ✓ 
 
Follow up for post-
operative 
complications 
  
  
  
     
     ✓ 
 
 
  
 
 
 
14. Sample size: 
 
15. Recruitment: 
• Patients' data will be enrolled in database of the Outpatient clinics of the 
Department of Oral & maxillofacial surgery, Faculty of Dentistry, Cairo University 
• If there is a potential eligibility, the patient will be examined thoroughly as 
described before.  
• Consecutive sampling is done through screening of patients. This will continue until 
the target population is achieved. 
• Identifying and recruiting potential subjects is achieved through patient database 
  
B) Assignment of interventions 
16. Allocation: 
16a. Randomization: 
Dr. M.O. will carry out the randomization process using a software www.rand.org with a 
ratio of 1:1.  
 
16b. Allocation concealment mechanism:  
14 Cards will have sequential numbers one number for each card then these cards will 
be placed within opaque sealed envelopes. Then these envelops will be placed in a 
container (box), each participant will grasp one envelop the day of procedure. This step 
will be done by Dr. M.O. 
 

16c. Implementation 
 Dr. M.O. is the person who will enroll the participants and assign the participants for 
intervention  
 
17. Masking/blinding: 
This trial is considered a randomized double blind clinical trial due to the following:  
1. The participant will be blinded to the technique that will be used during the surgical 
operation.  
2. The outcome assessor will be blinded  
3. The operator (DR.B.S.) will not be blinded for both techniques during the surgical operation, 
as the two techniques are different. (Dr. M.O.). 
 
The purpose of double blinding procedure is to reduce assessment bias and to increase 
accuracy and objectivity of clinical outcomes.  
 
 
 
C) Data collection, management, and analysis: 
18. Data collection methods 
 
• Primary Outcome:  
• The researcher (DR.B.S) and (Dr. M.O.) assistant supervisor. Will do the 
radiographic analysis. 
 
Plans to promote participant retention and complete follow- up:  
 
• Participant Retention: 
   A periodic regular follow up recalls will be planned every month for 3 months.  
 
• Participant Withdrawal: 
The patient is allowed to drop at any time from the study Participant withdrawal will be 
recorded and the patient will be excluded from the study. 
A percentage in the sample size is calculated to make up for any losses. 
The investigator also may withdraw participants from the study under strict certain 
conditions and only if the proposed therapy were considered harmful to the patient. 

 
19. Data management: 
- Data forms and data entry  
   All these procedures will be done by Prof.Dr. S.T.:  
• All data will be entered electronically.   
• Patient files are to be stored in numerical order and stored in secure and accessible 
place.  
• All data will be maintained in storage for 1 year after completion of the study.  
• The electronic data and the scans of the patient will be backed up on a Drop box file 
for ensuring back up and ease of accessibility.  
  
- Data Transmission and editing  
The assessor data entry will be transmitted from the assessors to database officer in 
the blind separate datasheets who in return record them in participant chart before 
sending them to the statistician.  
 
-Security and Back-up of data  
All forms of the procedures related to study data will be kept in the project secure 
folder. Access to the study data will be restricted only to database officer. A complete 
back up of the primary database will be performed twice a month. Back-ups of 
periodic data analysis file will be kept.  
 
 
20. Statistical methods: 
Statistical analysis will be done later after approval of the board of Oral & Maxillofacial 
Surgery Department, Faculty of Dentistry – Cairo University. 
 
D) Data monitoring: 
21. Monitoring 
The main supervisor Prof.Dr.S.M. Will be responsible for data monitoring. He will 
evaluate the outcome measures and any possible side effects that might affect the 
outcome.  

 
22. Harms 
                                                             Harm 
           Intra-operative complications 
          Post-operative complications 
Harms 
Avoidance&treatment 
Harms 
Avoidance&treatment 
 
 
Bleeding  
 
Care during implant 
placement  
 
 
 
Infection  
 
Antibiotic  
(Unasyn 1.5gm 1*2*7)  
(Flagyl 
500mg 
vial 
1*3*7)  
proper 
wound 
hygiene measures  
 
23. Audit 
Auditing of the study design will be done by Dr. M.O. the assistant supervisor 
.  
IV. Ethics and dissemination 
24. Research ethics approval 
This protocol and the template informed consent form will be reviewed by the Ethics 
Committee of Scientific Research - Faculty of Dentistry – Cairo University  
25. Protocol amendments 
Any modifications to the protocol which may impact on the conduct of the study, potential 
benefit of the patient or may affect patient safety, including changes of study objectives, 
study design, sample sizes, study procedures, or significant administrative aspects will 
require a formal amendment to the protocol. Such amendment will be agreed upon by the 
Council of oral and maxillofacial surgery department.  
 
26. Informed consent 
      Researcher B.S .will introduce and discuss the trial to patients who will be shown a 
video regarding the main aspects of the trial. Patients will then be able to have an 
informed discussion with the participating consultant. Researcher will obtain written 
consent from patients willing to participate in the trial. All consent forms will be 
translated into Arabic. 
 
 
 
 
 
 

27. Confidentiality 
• All study-related information such as photos, CBCT images, forms, charts will be 
stored in a password protected folder on the department database.  
• The password will be available to the study team.  
• But any personal information related to the patient’s ID will be stored in and will 
acquire a coded ID with access only to the database officer.  
28. Declaration of interest 
The study is self-funded and there is no conflict of interest to declare.  
29. Access to data 
All the research team will have access to the data sets. All data sets will be password 
protected. To ensure confidentiality, data dispersed to project team members will be 
blinded of any identifying participant information and the participant will be only 
identified by patient number.  
30. Post-trial care 
All patients will have the primary research contact number in case there is any 
emergency.  
      Follow up will continue until all patients are satisfied.  
31. Dissemination policy 
Study results will be published as partial fulfillment of the requirements for master’s 
degree in Oral and maxillofacial surgery.  
Topics suggested for presentation or publication will be circulated to the authors.  
 
V. Appendices 
32. Informed consent 
 
 
 
 

Diagnostic chart  
Patient No. ……..  
Name:    
  
  Age:    
    Sex:    
   
Weight:    
Occupation:    
  Address:    
  
  Contact No.:    
Medical history  
………………………………………………………………………………
……………..  
   History of facial trauma with fractures of facial bones.       
   History of surgical operation in nasal region.  
   Facial asymmetry.  
   Clefts (lip and palate)                                                                      
   Any accompanying craniofacial syndromes.  
   Any diseases that compromise bone or soft tissue healing.  
     Medically compromised not fit for general anesthesia.  
Dental history  
……………………………………………………………………  
 Previous restorations  
  Previous extraction  
  Previous orthodontic treatment  
Anterior open bite 
  Dental IQ  
   
  
  Motivation for treatment     
 
                                                                                                            Examining 
doctor 
 

 
VI. References 
1. CLINICAL AND RADIOGRAPHIC EVALUATION OF OSSEODENSIFICATION 
VERSUS OSTEOTOME FOR SINUS FLOOR ELEVATION IN PARTIALLY 
ATROPHIC MAXILLA: A PROSPECTIVE LONG TERM STUDY Shereen W 
Arafat* and Mohamed A Elbaz** 
https://edj.journals.ekb.eg/article_71261_ed987b0840ffacb78fc72259
2cb620ed.pdf 
 
2. Primary Stability of Implant in Closed Sinus Lifting Cases Using Densa Bur 
Versus Osteotome  https://clinicaltrials.gov/ct2/show/NCT03559777 
 
3. Patient Perception and Radiographic Assessment of Sinus Lifting Procedure 
using Densa Bur versus Osteotome-mediated sinus lifting: A Randomized 
Clinical 
Thttps://adjc.journals.ekb.eg/article_165194_0f7e7df225cb83b2ace99f7d
370d885c.pdf