| 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
|
|
|
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. |