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CTRI Number  CTRI/2019/03/018247 [Registered on: 25/03/2019] Trial Registered Prospectively
Last Modified On: 14/12/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of bone graft,growth factor (CGF) membrabne and coronally advanced flap (CAF) in treatment of gingival recession. 
Scientific Title of Study   Evaluation of the efficacy of sticky bone and concentrated growth factor (CGF) membrane along with a coronally advanced flap (CAF) as compared to coronally advanced flap alone in the treatment of Millers class I and class II gingival recession defects. 
Trial Acronym  SBCGF 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Dipika Mitra 
Designation  Professor and HOD 
Affiliation  Terna Dental College and Hospital 
Address  Terna Dental College and Hospital Plot No. 12, Sector 22, Opp. Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9820180406  
Fax    
Email  drdipikamitra@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Dipika Mitra 
Designation  Professor and HOD 
Affiliation  Terna Dental College and Hospital 
Address  Terna Dental College and Hospital Plot No. 12, Sector 22, Opp. Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9820180406  
Fax    
Email  drdipikamitra@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Shazneen Kandawalla 
Designation  Post graduate student 
Affiliation  Terna Dental College and Hospital 
Address  Terna Dental College and Hospital Plot No. 12, Sector 22, Opp. Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra 400706

Mumbai
MAHARASHTRA
400706
India 
Phone  9820867934  
Fax    
Email  shazneen.kandawalla@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  Terna Dental College 
Address  Terna Dental College and Hospital Plot No. 12, Sector 22, Opp. Nerul West Railway Station, Nerul  
Type of Sponsor  Other [private dental college] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shazneen kandawalla  TPCTs Terna Dental College  Department of periodontics, room no. 103, Plot No. 12, Sector–22, Opp. Nerul West Railway Station, Nerul West, Navi Mumbai, Maharashtra 400706 Mumbai MAHARASHTRA
Thane
MAHARASHTRA 		 9820867934

shazneen.kandawalla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Terna Dental College Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  systemically healthy individuals with Millers Class I and Class II gingival recession 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coronally advanced flap alone  Coronally advanced flap alone in the treatment of Millers Class I and Class II gingival recession defects 
Intervention  sticky bone, concentrated growth factor membrane along with coronally advanced flap  sticky bone, concentrated growth factor membrane along with coronally advanced flap in the treatment of Millers Class I and Class II gingival recession defects 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Patients with Millers class I and/or
class II recession defects.
2 Patients between the age group of 18 – 60 yrs.
3 Patients maintaining good oral hygiene.
4 Systemically healthy patients.
5 Patients who give informed consent to participate in the study.
6 Patients who do not consume tobacco in any form.
 
 
ExclusionCriteria 
Details  1 Pregnant and lactating females.
2 Patients who have undergone any periodontal surgical therapy in the last 6 months in the same site.
3 Patients taking anticoagulants and anti-platelet drugs
4 Patients with allergies to materials used in treatment process
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in depth and width of Miller’s class I and class II gingival recession.
 		 baseline
1 month
3 month
6 month 
 
Secondary Outcome  
Outcome  TimePoints 
To measure and compare the improvement in relative attachment level, width of attached gingiva and gingival mucosal thickness in patients with Miller’s class I and class II gingival recessions, using coronally advanced flap alone or in combination with sticky bone and concentrated growth factor  baseline
1 month
3 month
6 month
In addition to the above, the gingival mucosal thickness and the
relative attachment level will also be calculated at baseline and at 6
months. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/04/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  		 none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

This is a clinical trial to determine the efficacy of sticky bone and concentrated growth factor (CGF) membrane along with a coronally advanced flap (CAF) as compared to coronally advanced flap alone in the treatment of Millers class I and class II gingival recession defects that will be conducted in Terna Dental College, India. The primary outcome will be to measure the depth and width of recession at 1, 3 and 6 months after surgery.

6 patients have been recruited for the trial as per inclusion criteria.

Case histories were taken and phase 1 therapy was performed on all subjects.

Impressions were taken and stents were prepared.

Routine blood investigations were done and informed consent was taken

Cornally advanced flap surgery was performed on the control site and coronally advanced flap with sticky bone and CGF membrane was performed on the test site. 

Progress:

2 of 6 subjects have completed 6 months followup, clinical parameters were assessed.

4 of 6 subjects have completed 3 months followup, clinical parameters were assessed


 
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