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CTRI Number  CTRI/2024/07/071448 [Registered on: 29/07/2024] Trial Registered Prospectively
Last Modified On: 14/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study of the treatment outcomes of a cell seeded collagen matrix in patients with gingival/gum recession. 
Scientific Title of Study   A comparative clinical evaluation of the treatment outcomes of an autologus fibroblast seeded volume stable collagen matrix vs volume stable collagen matrix alone in class I and class II gingival recession defects. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Devapriyan S 
Designation  Post Graduate student  
Affiliation  Ragas Dental College and Hospital 
Address  Department of Periodontics,Room number: 6 Ragas Dental College and Hospital #2/102,East Coast Road,Uthandi,Chennai-119.

Chennai
TAMIL NADU
600119
India 
Phone  9629969587  
Fax    
Email  drdevapriyan1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Swarna Alamelu  
Designation  Professor  
Affiliation  Ragas Dental College and Hospital 
Address  Department of Periodontics Room number: 6 Ragas Dental College and Hospital #2/102,East Coast Road,Uthandi,Chennai-119.

Chennai
TAMIL NADU
600119
India 
Phone  9176681845  
Fax    
Email  swarna_alamelu@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Shivakumar 
Designation  Professor  
Affiliation  Ragas Dental College and Hospital 
Address  Department of Periodontics Room number: 6 Ragas Dental College and Hospital #2/102,East Coast Road,Uthandi,Chennai-119.

Chennai
TAMIL NADU
600119
India 
Phone  9840479181  
Fax    
Email  shivabaskaran@rediffmail.com  
 
Source of Monetary or Material Support  
Ragas dental college and hospital,2/102,east coast road ,uthandi,chennai-600119.india 
 
Primary Sponsor  
Name  Dr Devapriyan S Ragas dental college and hospital 
Address  Ragas dental college and hospital 2/102,east coast road,uthandi,Chennai-119  
Type of Sponsor  Other [Private Dental College and Hospital ] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Sivaram G  Ragas dental college and hospital #2/102,East Coast Road,Uthandi,Chennai-119. 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrDevapriyan S  Ragas Dental College and Hospital  Room Number 6, Deartment of Periodontics, 2/102,East coast road,uthandi,chennai-119
Chennai
TAMIL NADU 
9629969587

drdevapriyan1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICS COMMITTEE ,RAGAS DENTAL COLLEGE AND HOSPITAL,UTHANDI,CHENNAI-119  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Coronally advanced flap with Auotlogous Fibroblast Seeded volume stable collagen matrix   Comparator - Treatment of Class I and Class II Gingival Recession by coronally advanced flap procedure with two types of collagen matrix Control - Volume stable collagen matrix(fibro gide), comparator agent - Autologous fibroblast-seeded volume stable collagen matrix(fibro gide), The baseline values of the recession are recorded RD-recession depth,RW-recession width ,WKT-Width of Keratinized TissueK,T-Keratinized Tissue Thickness,PD-Probing Depth,CAL-Clinical Attachment Level treatment is carried out in a split mouth design with one site receiving the control and the recession on the contralateral site receiving the test material. Post intervention, values are recorded at duration 1, 3 and 6 months 
Intervention  Coronaly Advanced Flap with volume stable collagen matrix   Intervention - Treatment of Class I and Class II Gingival Recession by coronally advanced flap procedure with two types of collagen matrix Control - Volume stable collagen matrix(fibro gide) The baseline values of the recession are recorded RD-recession depth,RW-recession width ,WKT-Width of Keratinized TissueK,T-Keratinized Tissue Thickness,PD-Probing Depth,CAL-Clinical Attachment Level treatment is carried out in a split mouth design with one site receiving the control and the recession on the contralateral site receiving the test material. Post intervention, values are recorded at duration 1, 3 and 6 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  18 to 40 years of age
Systemically healthy patient
Patients having Class I/II gingival recession
Patients exhibiting good oral hygiene
 
 
ExclusionCriteria 
Details  Smokers.
Pregnant and Lactating women.
Medically compromised patients.
Patients with known history of allergy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
complete root coverage (CRC)
RD-recession depth
RW-recession width 
Base line
1 month
3 month
6 month 
 
Secondary Outcome  
Outcome  TimePoints 
WKT-Width of Keratinized Tissue
KT-Keratinized Tissue Thickness
PD-Probing Depth
CAL-Clinical Attachment Level 
Base line
1 month
3 month
6 month 
 
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)   15/08/2024 
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="9"
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 - NO
Brief Summary  

Gingival recession is defined as exposure of the root surface or the apical shift of the gingival margin from the cemento-enamel junction( CEJ) with a multifactorial etiology, leading to hypersensitivity. Gingival fibroblasts are known to play a critical role in periodontal wound healing and regeneration. The  autogenous connective tissue graft (CTG) is considered as the gold standard in the  management of gingival  recession, but the associated donor site morbidity hinders its widespread  applicability. Since then, allogenic and xenogenic collagen matrices have found its way in the repertoire of various periodontal treatment modalities for gingival management. The purpose of this trial is to study the clinical efficacy of one such volume stable collagen matrix (Fibro-Gide)which  is of xenogenic in origin, resorbable  and specifically designed for soft-tissue regeneration. It is made of reconstituted collagen and undergoes smart chemical cross-linking to improve its volume stability while maintaining a good biocompatibility. The study also aims to study and compare the above matrix with autologous fibroblast seeded on to it in the treatment of class I class II gingival recession defects, wherein the fibroblasts are known to  have an  important role in the  regeneration of periodontal ligament along with the  volume stable collagen matrix ( Fibro-Gide) which further supports angiogenesis, formation of new connective tissue and stability of the collagen network in the surrounding soft-tissue.


 
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