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CTRI Number  CTRI/2024/10/076058 [Registered on: 29/10/2024] Trial Registered Prospectively
Last Modified On: 09/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Management of gum loss in adults using tissue obtained from roof of their mouth or tissue obtained from animals 
Scientific Title of Study   Comparative valuation of outcomes of xenogeneic pericardial collagen membrane enriched with injectable platelet rich fibrin(i-prf) and connective tissue graft in the treatment of gingival recession- A prospective clinical study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kiran choudhary 
Designation  first year postgraduate  
Affiliation  SRM dental college 
Address  Department of periodontology, SRM dental college, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600089
India 
Phone  9666966033  
Fax    
Email  kc4893@srmist.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Anupama Tadepalli  
Designation  Professor 
Affiliation  SRM dental college 
Address  Department of periodontology, SRM dental college, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600089
India 
Phone  9677065517  
Fax    
Email  anupamamds@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anupama Tadepalli  
Designation  Professor 
Affiliation  SRM dental college 
Address  Department of periodontology, SRM dental college, Bharathi Salai, Ramapuram, Chennai, Tamil Nadu

Chennai
TAMIL NADU
600089
India 
Phone  9677065517  
Fax    
Email  anupamamds@gmail.com  
 
Source of Monetary or Material Support  
SRM Dental college , Department of Periodontology , 3rd floor , Bharathi Salai , Ramapuram campus , Chennai , Tamil Nadu , India, 600089 
 
Primary Sponsor  
Name  kiran choudhary 
Address  1st yr MDS student, Department of Periodontology, SRM Dental college, Bharathi salai, Ramapuram campus, Chennai 600089 
Type of Sponsor  Other [Self funded ] 
 
Details of Secondary Sponsor  
Name  Address 
SRM Dental College  Department of Periodontology, SRM Dental college, Bharathi salai, Ramapuram campus, Chennai 600089 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrAnupama Tadepalli  SRM Dental college   Department of Periodontology, 3rd floor , SRM dental college , Bharathi salai, Ramapuram, Chennai,600089
Chennai
TAMIL NADU 		 9677065517

anupamamds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM DENTAL COLLEGE INSTITUTIONAL REVIEW BOARD  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  De-epithelialized free gingival graft group   The gingival recession sites will be treated using de-epithelized palatal tissue graft with coronally advanced flap(CAF)and follow-up will be done for 6months 
Intervention  Xenogeneic pericardial collagen membrane graft group   The gingival recession sites will be treated with xenogeneic pericardial collagen membrane(XCM) impregnated with injectable platelet rich fibrin(I-PRF) along with coronally advanced flap(CAF) and follow-up will be done for 6months. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Systemically healthy subjects with an age range of 25-50 years.
2. Individuals diagnosed with recession defects in maxillary anteriors and premolars that is the Cairo’s RT1, RT2 classes of recession
3. Sites with minimum depth of recession more or equal to 4mm
4. Isolated or multiple adjoining recession involving less or equal to 3 teeth. 
 
ExclusionCriteria 
Details  1. Sites with probing pocket depth ≥4mm.
2.Teeth with mobility and/or associated with trauma from occlusion.
3. Sites with dental caries and prosthetic restorations.
4.Patients who exhibit unacceptable oral hygiene compliance during/or after phase Ι therapy.
5.Smokers.
6.Pregnant and lactating women.
7.Patient known allergic response with xenogeneic derived substances.
8.Patients with known platelet disorders or using any medication that are known to interfere with platelet function.
9.Patients with systemic conditions or disease influencing the course of periodontal disease and therapy. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within XCM+i-PRF group.
2. To assess and compare the changes in the recession height (RH) from baseline to 6 months, within CAF+DFGG group.
3. To assess and compare the changes in the recession height from baseline to 6 months between XCM+i-PRF and CAF+DFGG groups. 		 baseline and 6months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess and compare the percentage of complete root coverage (CRC%) achieved at 6 months between XCM+i-PRF and CAF+DFGG group.
2. To assess and compare the patient perception regarding pain following the treatment modalities by using visual analogue scale score (VAS-P) 		 6months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/11/2024 
Date of Study Completion (India) 23/12/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Gingival recession is a prevalent  periodontal condition where the apical migration of gingival tissue causes exposure of the root surface and results in hypersensitivity, root caries , esthetic concerns to patients. The coronally advanced flap (CAF) along with connective tissue graft (CTG) is one of the most effective techniques for the management of Miller Class I and II recessions because it offers excellent esthetic results, highest root coverage. However, in patients with multiple gingival recession defects and having thin gingival phenotype, harvesting CTGs of adequate dimensions are clinically challenging due to the limited donor area. Recently the allogeneic or xenogeneic  membranes or matrices have been employed along with platelet concentrates to improve root coverage and as an alternative treatment protocol to CTG . In this study we are proposing to compare the efficacy of  combination of xenogeneic pericardial membrane and injectable platelet concentrate  with de-epithelized free gingival graft tissue along with coronally advanced flap in management of maxillary gingival recession.
 
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