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CTRI Number  CTRI/2025/07/090171 [Registered on: 04/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   New Gum Recession Treatments Compared: Volume stable Collagen Matrix vs. PRF with Flap Surgery 
Scientific Title of Study   Comparative Evaluation of Volume Stable Collagen Matrix and Platelet Rich Fibrin Using Modified Coronally Advanced Flap Technique in The Management of Isolated Gingival Recession Defects – A Clinical Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAashlesha Sureshkumar Raut 
Designation  Postgraduate student 
Affiliation  Dr D Y Patil Dental College and Hospital  
Address  Department of Periodontology Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9823305299  
Fax    
Email  aashlesharaut6@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sharath K Shetty 
Designation  PG Guide and Head of Department  
Affiliation  Dr D Y Patil Dental College and Hospital  
Address  Department of Periodontology Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9823816016  
Fax    
Email  sharath.shetty@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  DrAashlesha Sureshkumar Raut 
Designation  Postgraduate student 
Affiliation  Dr D Y Patil Dental College and Hospital  
Address  Department of Periodontology Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune

Pune
MAHARASHTRA
411018
India 
Phone  9823305299  
Fax    
Email  aashlesharaut6@gmail.com  
 
Source of Monetary or Material Support  
Dr D.Y. Patil Dental College and Hospital Pimpri Pune 
 
Primary Sponsor  
Name  Dr Aashlesha Raut 
Address  Departemtn of Periodontology Dr D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune 411018 
Type of Sponsor  Other [SELF] 
 
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 Aashlesha Raut  Dr D Y Patil Dental College and Hospital  Department of Periodontology Dr. D Y Patil Dental College and Hospital Sant Tukaram Nagar Pimpri Pune
Pune
MAHARASHTRA 		 9823305299

aashlesharaut6@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and Recognition Committee under Faculty of Dentistry at Dr. D.Y Patil Vidyapeeth Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Platelet Rich Fibrin  Platelet Rich Fibrin membrane along with Modified Coronally Advaced Flap in treating isolate gingival recession  
Intervention  Volume stable collagen matrix   Volume-stable collagen matrix along with modified coronally advanced flap to treat isolated gingival recession. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group of 20 to 60 years
Presence of Cairo‘s Recession Type 1 defects in maxillary anterior and premolars region.
Presence of single tooth gingival recession sites bilaterally.
CEJ visible on the recessed teeth.
Presence of at least 1mm of residual keratinized tissue around target tooth.
Full mouth Plaque score less than 20 percent
Subjects with healthy or effectively treated periodontal conditions.
Patients willing to comply with all study related procedures.
Patients with adequate Platelet Count.  
 
ExclusionCriteria 
Details  Pregnant or Lactating women.
Tobacco in any form.
Presence of Recession in Mandibular teeth.
Patients with known history of any systemic diseases like hypertension diabetes HIV
bone metabolic disorders radiation therapy immunosuppressive therapy cancer.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Gingival Recession Depth, Clinical attachment level ,
Percentage of root coverage 		 Gingival recession depth and Clinical attachment level at baseline and 6 Months.
Percentage of root coverage at 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
gingival index (GI), plaque index (PI), probing depth (PD), keratinized tissue width (KTW), gingival thickness (GT), and the Root Coverage Esthetic Score (RES).  Baselien and 6 months 
 
Target Sample Size   Total Sample Size="10"
Sample Size from India="10" 
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   N/A 
Date of First Enrollment (India)   15/07/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aashlesharaut6@gmail.com].

  6. For how long will this data be available start date provided 06-04-2026 and end date provided 06-04-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aim: This study aimed to evaluate and compare the clinical efficacy of Volume Stable Collagen Matrix (VSCM) and Platelet-Rich Fibrin (PRF) using the Modified Coronally Advanced Flap (MCAF) in managing Isolated Gingival Recession Defects.

Methods: In this split-mouth interventional clinical study, 10 patients with Cairo’s RT1 single-tooth bilateral gingival recession is to be enrolled, and a total of 20 recession sites will be allocated to either the Test (VSCM + MCAF; n = 10 sites) and the contralateral site as Control (PRF + MCAF; n = 10 sites). Primary clinical parameters will be  assessed -  gingival recession depth , clinical attachment level , and percentage of root coverage. Secondary parameters included gingival index , plaque index , probing depth, keratinized tissue width , gingival thickness , and the Root Coverage Esthetic Score . All measurements will be recorded at baseline and 6 months postoperatively. Descriptive statistics were calculated for mean and standard deviation. Intragroup comparisons will be performed using paired t-tests, while intergroup comparisons will be analysed using unpaired t-tests. Statistical significance  set at p < 0.05 (two-tailed) with a 95% confidence interval.

 
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