| CTRI Number |
CTRI/2024/03/063988 [Registered on: 12/03/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The use of human self generated material obtained from drawing blood versus animal derived substitute material that is available in the market in the treatment of receding gums using a technique involving to pouch the material by creating a tunnel in the gums. |
|
Scientific Title of Study
|
Clinical efficacy of autogenic versus xenogenic substitute as an adjunct to pouch and tunnel technique for the management of multiple RT l gingival recession - a randomised control 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 |
Arvina Rajasekar |
| Designation |
Professor |
| Affiliation |
Saveetha dental college and hospital, SIMATS UNIVERSITY |
| Address |
Department of peridontology,
Clinic 25, 4th floor,
No. 162, Poonamallee High Road,
Vellapanchavadi, Chennai 600077
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9486442309 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arvina Rajasekar |
| Designation |
Professor |
| Affiliation |
Saveetha dental college and hospital, SIMATS UNIVERSITY |
| Address |
Department of peridontology,
Clinic 25, 4th floor,
No. 162, Poonamallee High Road,
Vellapanchavadi, Chennai 600077
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9486442309 |
| Fax |
|
| Email |
arvinar.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Nivedha Nedumaran |
| Designation |
Post graduate |
| Affiliation |
Saveetha dental college and hospital, SIMATS UNIVERSITY |
| Address |
Saveetha dental college and hospital
Department of peridontology,
Clinic 25, 4th floor,
No. 162, Poonamallee High Road,
Vellapanchavadi, Chennai 600077
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9600177122 |
| Fax |
|
| Email |
152205003.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospital, SIMATS UNIVERSITY
clinic 25, 4th floor, No 162, Poonamallee High Road, vellapanchavadi, Chennai 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha dental college and hospital |
| Address |
Saveetha dental college and hospital
Department of periodontology
Clinic 25, 4th floor,
162, Poonamallee High Road, vellapanchavadi, Chennai 600077 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nivedha N |
Department of periodontology
Clinc 25, 4th floor,
No 162, Poonamallee High Road ,
Vellapanchavadi Chennai 600077 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nivedha N |
Saveetha Dental college and hospital |
Department of periodontology,
Clinic 25, 4th floor,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai 600077
Kancheepuram
TAMIL NADU |
9600177122
152205003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental college - Institutional human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Fibro-Gide material with pouch and tunnel technique |
Commercially available Xenogenic material (FIBRO-GIDE) used for recession management using tunnel and pouch techniques at the time of surgical intervention after baseline evaluation and follow up after 3 months and 6months |
| Intervention |
Platelet rich fibrin (PRF) with pouch and tunnel technique |
Autologous platelet rich concentrates ( PRF)used for recession management using pouch and tunnel technique at the time of surgical intervention after baseline evaluation with follow up after 3 months and 6months. |
| Comparator Agent |
Pouch and tunnel technique |
Use of tunneling technique to advance the flap at the time of surgical intervention after baseline evaluation and follow up after 3months and 6months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 patients with RT I gingival recession present
2 teeth with visible cementoenamel junction.
3 subjects were at least 20 years old.
4 participants with periodontal health.
5 General health status - ASA I Or ASA II ( AMERICAN SOCIETY OF ANESTHESIOLOGISTS) |
|
| ExclusionCriteria |
| Details |
1 smokers
2 subjects with cervical caries.
3 probing depth more than 4mm
4 subjects with history of periodontal therapy
5 pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque index
Probing depth
Clinical attachment level
Keratinised tissue gain
Gingival thickness
Recession width
Recession height
Mean root coverage
|
Baseline
3months
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recession esthetic score |
Baseline
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 2 |
|
Date of First Enrollment (India)
|
21/03/2024 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 the apical migration of the free gingival margin. This is related to be an esthetic concern among the individuals. This study aims to compare the autogenous materials like platelet rich fibrin( PRF) and the xenogenic material like ( FIBROGUIDE) using tunnel and pouch technique for the management of RTI defects. |