| CTRI Number |
CTRI/2025/05/086214 [Registered on: 02/05/2025] Trial Registered Prospectively |
| Last Modified On: |
01/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness and evaluation of outcome between two different techniques in managing gum recession - a clinical trial |
|
Scientific Title of Study
|
“A Comparative Evaluation of Tunneled Coronally
Advanced Flap(TCAF) and Double lateral Bridging Flap in the Management of RT1 Gingival re
cessions- A Randomized Clinical 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 |
Mohamed Thaha |
| Designation |
Post Graduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 25, 4th Floor, Department of Periodontics, Saveetha Dental College and Hospitals,162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, India.
Chennai
TAMIL NADU
600077
India |
| Phone |
08220694720 |
| Fax |
|
| Email |
mohamedthaha9991@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jaiganesh Ramamurthy |
| Designation |
Professor And Head of Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 25, 4th Floor, Department of Periodontics, Saveetha Dental College and Hospitals,162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, India.
Chennai
TAMIL NADU
600077
India |
| Phone |
9840443463 |
| Fax |
|
| Email |
jaiganeshr@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Jaiganesh Ramamurthy |
| Designation |
Professor And Head of Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 25, 4th Floor, Department of Periodontics, Saveetha Dental College and Hospitals,162, Poonamallee High Road, Velappanchavadi, Chennai, Tamil Nadu, India.
Chennai
TAMIL NADU
600077
India |
| Phone |
9840443463 |
| Fax |
|
| Email |
jaiganeshr@saveetha.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospitals |
| Address |
Saveetha Dental
college and Hospitals
162, Poonamallee High
Rd, Velappanchavadi,
Chennai, Tamil Nadu,
India-600077
Thiruvallur
TAMIL NADU
|
| 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 |
| Dr Jaiganesh Ramamurthy |
Saveetha Dental college and Hospitals |
Department of Periodontics, Clinic-25, 4th floor,
Saveetha Dental
college and Hospitals
162, Poonamallee High
Rd, Velappanchavadi,
Chennai, Tamil Nadu,
India-600077
Thiruvallur
TAMIL NADU
Chennai
TAMIL NADU |
08220694720
mohamedthaha9991@gmail.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: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Double Lateral Bridging flap technique |
Management of RT1 Gingival recession by Double lateral Bridging Flap Technique follow-up till 3 months |
| Intervention |
Tunneled Coronally advanced flap(TCAF) Technique |
Management of RT1 gingival recession by Tunneled coronally advanced flap(TCAF) follow-up till 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals with no active periodontal disease having RT1 gingival recession. |
|
| ExclusionCriteria |
| Details |
Periapical lesions, smokers, pregnant and lactating women, patients with systemic conditions, and existing periodontal disease. |
|
|
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 |
| Root coverage obtained, phenotype alterations, dental tooth hypersensitivity and Eesthetics |
Baseline, 1 week after intervention, 3 weeks after intervention, and after 3 months of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2025 |
| 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)
|
Not Yet Recruiting |
| 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
|
This randomized clinical trial aims to compare the clinical efficacy of the Traditional Coronally Advanced Flap (TCAF) and the Double Lateral Bridging Flap (DLBF) techniques in treating Recession Type 1 (RT1) gingival defects. A total of [insert sample size] patients presenting with isolated RT1 recessions will be randomly assigned to either the TCAF or DLBF treatment group. Clinical parameters, including recession depth, clinical attachment level, keratinized tissue width, and esthetic outcomes, will be recorded at baseline and at 3 and 6 months post-surgery. The primary objective is to assess the degree of root coverage, while secondary outcomes include patient satisfaction, esthetic score, and tissue stability. The study hypothesizes that DLBF may offer enhanced root coverage and superior esthetic outcomes compared to TCAF due to its dual blood supply and tissue preservation features. |