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CTRI Number  CTRI/2026/02/102914 [Registered on: 03/02/2026] Trial Registered Prospectively
Last Modified On: 21/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   COMPARATIVE EVALUATION OF SUBEPITHELIAL CONNECTIVE TISSUE GRAFT (SCTG),ADVANCED PLATELET RICH FIBRIN (A-PRF),AND COLLAGEN MATRIX DERIVATIVE MEMBRANE (CMDM) WITH CORONALLY ADVANCED FLAP (CAF)IN THE TREATMENT OF GINGIVAL RECESSION - A RANDOMIZED CONTROLLED CLINICAL TRIAL. 
Scientific Title of Study   COMPARATIVE EVALUATION OF SUBEPITHELIAL CONNECTIVE TISSUE GRAFT (SCTG),ADVANCED PLATELET RICH FIBRIN (A-PRF),AND COLLAGEN MATRIX DERIVATIVE MEMBRANE (CMDM) WITH CORONALLY ADVANCED FLAP (CAF)IN THE TREATMENT OF GINGIVAL RECESSION - A RANDOMIZED CONTROLLED CLINICAL TRIAL. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Priya 
Designation  Post graduate student 
Affiliation  J.N Kapoor D.A.V Centenary Dental College  
Address  J.N Kapoor D.A.V Centenary Dental College Model Town Yamunanagar Haryana 135001
J.N Kapoor D.A.V Centenary Dental College Model Town Yamunanagar Haryana 135001
Yamunanagar
HARYANA
135001
India 
Phone  8708534350  
Fax    
Email  sharmapriya84187@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nymphea Pandit 
Designation  Head of Department Of Periodontology and Oral Implantology 
Affiliation  J.N Kapoor D.A.V Centenary Dental College  
Address  J.N Kapoor D.A.V Centenary Dental College Room no. 8 Model Town Yamunanagar Haryana 135001
J.N Kapoor D.A.V Centenary Dental College room no.8 Model Town Yamunanagar Haryana 135001
Yamunanagar
HARYANA
135001
India 
Phone  9416493962  
Fax    
Email  drnymphea68@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priya 
Designation  Post graduate student 
Affiliation  J.N Kapoor D.A.V Centenary Dental College  
Address  J.N Kapoor D.A.V Centenary Dental College Model Town Yamunanagar Haryana 135001
J.N Kapoor D.A.V Centenary Dental College Model Town Yamunanagar Haryana 135001
Yamunanagar
HARYANA
135001
India 
Phone  8708534350  
Fax    
Email  sharmapriya84187@gmail.com  
 
Source of Monetary or Material Support  
J.N Kapoor D.A.V Centenar Dental College Model Town Yamuna Nagar Haryana 135001 
 
Primary Sponsor  
Name  J.N Kapoor Dav Centenary Dental College 
Address  JN Kapoor DAV Centenary Dental College Model Town Yamunanagar Haryana 135001 
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 Priya  J.N Kapoor Dav Dental College Model Town Yamunanagar Haryana 135001   Department of Periodontology and Oral Implantology room no-8
Yamunanagar
HARYANA 		 8708534350

sharmapriya84187@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patients With Gingival Recession 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A-PRF  A-PRF + Coronally Advanced Flap (CAF) with recall of 3 and 6 months 
Intervention  Collagen Matrix Derivative Membrane (CMDM)  Collagen Matrix Derivative Membrane (CMDM) + Coronally Advanced Flap (CAF) with recall of 3 and 6 months 
Comparator Agent  Subepithelial Connective Tissue Graft (SCTG)  Subepithelial Connective Tissue Graft (SCTG) + Coronally Advanced Flap (CAF) with recall of 3 and 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. The patients with age more than 18 years.
2. The patients must have gingival recession of at least two adjacent teeth with a
minimum depth of 2mm in the maxillary anterior region exhibiting a labial gingival
recession defect classified as either Millers Class I or Class II.
3. No history of previous root coverage procedures.
4. The patients must be able to maintain good oral hygiene and control gingivitis
throughout the entire dentition (FMPS less than 25 percent and FMBS less than 25 percent).
5.Patients with no previous history of periodontal surgical intervention in the area
affected. 
 
ExclusionCriteria 
Details  1. Patients with Self-reported smoking of more than 20 cigarettes per day or the use
of pipes or cigars.
2. Patients with Known sensitivity to collagen-based medical products.
3. Pregnancy.
4. Patients with poorly controlled diabetes.
5. Patients whose teeth have been completely restored, or whose status exhibited
mobility, cervical abrasion, caries, or abfraction.
6. Medications or treatments known to affect mucosal wound healing (e.g. steroids,
large doses of anti-inflammatory drugs, anticoagulation drugs).
7.Gingival recessions on second/third molar teeth or on malpositioned teeth.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Outcomes
Depth of recession (RD)
Width of recession (RW)
Width of keratinized tissue (KT)
Gingival thickness (GT) 		 Baseline (pre-operative)

3 months post-operative

6 months post-operative 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcomes
Plaque index (PI)
Gingival index (GI)
Probing depth (PD)
Clinical attachment level (CAL) 		 Baseline (pre-operative)

3 months post-operative

6 months post-operative 
 
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 1/ Phase 2 
Date of First Enrollment (India)   20/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/02/2026 
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)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 20-06-2025 and end date provided 20-06-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   RESEARCH QUESTION 
Whether Subepithelial Connective Tissue Graft (SCTG), Advanced Platelet Rich Fibrin (A-PRF), and Collagen Matrix Derivative Membrane (CMDM) in conjunction with Coronally Advanced Flap (CAF) is effective and comparable for the treatment of gingival recession.

AIM & OBJECTIVES Aim 
To evaluate and compare the clinical effectiveness of Subepithelial Connective Tissue Graft (SCTG), Advanced Platelet Rich Fibrin (A-PRF), and Collagen Matrix Derivative Membrane (CMDM) as adjuncts to Coronally Advanced Flap (CAF) in the treatment of gingival recession. 
Objectives —
1. To evaluate clinically the efficacy of recession coverage using Subepithelial Connective Tissue Graft with Coronally Advanced Flap. 
2. To evaluate clinically the efficacy of recession coverage using Advanced Platelet Rich Fibrin with Coronally Advanced Flap. 
3. To evaluate clinically the efficacy of recession coverage using Collagen Matrix Derivative Membrane with Coronally Advanced Flap. 
4. To compare clinically the efficacy of Subepithelial Connective Tissue Graft, Advanced Platelet Rich fibrin, Collagen Matrix Derivative Membrane with Coronally Advanced Flap.
 
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