| CTRI Number |
CTRI/2020/09/027873 [Registered on: 17/09/2020] Trial Registered Prospectively |
| Last Modified On: |
07/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative evaluation of two different treatment modalities for the treatment of gingival recession: A randomized clinical trial |
|
Scientific Title of Study
|
Comparative evaluation of root coverage procedure using coronally advanced flap with or without resorbable type I collagen membrane for treatment of Miller’s Class I or Class II gingival recession defects: A Randomized clinical trial.
|
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tejashvi Seth |
| Designation |
Post-graduate student |
| Affiliation |
post-graduate student at MGVs KBH Dental college and hospital |
| Address |
MGVs KBH DENTAL COLLEGE,
PANCHVATI, NASHIK
Nashik
MAHARASHTRA
422003
India |
| Phone |
|
| Fax |
|
| Email |
seth.tejashvi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Triveni Kale |
| Designation |
Professor |
| Affiliation |
Professor at MGVs KBH Dental college and hospital |
| Address |
MGVs KBH Dental College,
Panchvati, Near Mumbai-Agra road, Nashik
Nashik
MAHARASHTRA
422003
India |
| Phone |
|
| Fax |
|
| Email |
triv19792018@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tejashvi Seth |
| Designation |
Post-graduate student |
| Affiliation |
post-graduate student at MGVs KBH Dental college and hospital |
| Address |
MGVs KBH DENTAL COLLEGE,
PANCHVATI, NASHIK
Nashik
MAHARASHTRA
422003
India |
| Phone |
|
| Fax |
|
| Email |
seth.tejashvi@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGVs KBH Dental college and hospital |
|
|
Primary Sponsor
|
| Name |
MGVs KBH dental college and hospital |
| Address |
MGVs KBH dental college and hospital, panchvati,near mumbai-agra road,nashik. |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tejashvi Seth |
MGVs KBH Dental college and hospital |
301,302 department of periodontology.
Nashik
MAHARASHTRA |
9820436538
seth.tejashvi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGVs KBH DENTAL COLLEGE ETHICS COMITTEE |
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 |
root coverage procedure |
coronally advanced flap IN Miller’s Class I or Class II gingival recession defects will be conducted once only
|
| Comparator Agent |
ROOT coverage procedure |
coronally advanced flap with placement of resorbable type I collagen membrane in Miller’s Class I or Class II gingival recession defects will be done once only |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.Presence of gingival recession classified as Millers Class I or II recession defects in upper canines and premolars. Ability to maintain good oral hygiene. Absence of clinical signs of active periodontal disease. |
|
| ExclusionCriteria |
| Details |
Patients with known systemic disease.History of prolonged use of antibiotics.Pregnant and lactating women.History of tobacco use in any form. Gingival recession is associated with severe cervical caries. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Amount of root coverage |
To be evaluated at baseline, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
clinical attachment level gain
width of keratinized tissue |
To be evaluated at baseline, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
25/09/2020 |
| Date of Study Completion (India) |
15/01/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The rationale for using collagen membranes for guided tissue regeneration-based root coverage is that it is a natural material which is biocompatible with the host, its absorbable entity provides a scaffold for tissue repair while augmenting gingival tissue thickness via in vivo expansion, possessing a chemotactic function that encourages host cell migration and attachment, semipermeable allowing gas and nutrient exchange, such characteristics lead to promotion of clot formation, primary wound closure, better wound stability and healing, angiogenesis, and clot stability. We hypothesize that coronally advanced flap with resorbable type I collagen the membrane will positively affect the treatment outcomes of Miller’s Class I or Class II gingival recession defects. |