| CTRI Number |
CTRI/2025/05/087266 [Registered on: 21/05/2025] Trial Registered Prospectively |
| Last Modified On: |
21/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of gum recession areas using a modified tunnel technique with a surface gum piece versus inner gum layer. |
|
Scientific Title of Study
|
Treatment of multiple adjacent gingival recession by modified coronally advanced tunnel technique using subepithelial connective tissue graft versus de-epithelialized free gingival graft |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Deemed to be University |
| Address |
Dept of Periodontology,Room no. 7,MMCDSR,Mullana,Ambala,Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Deemed to be University |
| Address |
Dept of Periodontology,Room no. 7,MMCDSR,Mullana,Ambala,Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Surinder Sachdeva |
| Designation |
Professor and Head |
| Affiliation |
Maharishi Markandeshwar Deemed to be University |
| Address |
Dept of Periodontology,Room no. 7,MMCDSR,Mullana,Ambala,Haryana.
Ambala
HARYANA
133207
India |
| Phone |
8199980802 |
| Fax |
|
| Email |
sksperio@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sweta kumari |
| Address |
Room no 7, Department of Periodontology, MMCDSR, Mullana, Ambala,Haryana 133207 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Sweta Kumari |
Maharishi Markandeshwar College of Dental Science and Research |
Dept of Periodontology,Room no. 7,MMCDSR,Mullana,Ambala,Haryana.
Ambala
HARYANA |
9519619418
Swetavrudra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Maharishi Markandeswar Deemed to be University |
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 |
De-epithelialized connective tissue graft |
Recession coverage by modified coronally advanced tunnel technique using de-epithelialized free gingival graft. |
| Comparator Agent |
Sub epithelial connective tissue graft |
Recession coverage by modified coronally advanced tunnel technique using sub epithelial connective tissue graft |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age betweetn 18 to 60 years
2.No systemic disease that may affect wound healing.
3.Presence of multiple adjacent Miller class 1 and 2 buccal gingival recession defects.
4. Cooperative and motivated patients committed to oral hygiene. |
|
| ExclusionCriteria |
| Details |
1.Presence of Carious lesion or restoration in the cervicalarea of teeth.
2.Intake of medications which which impede periodontal tissue health health and healing.
3.Medical contraindications for periodontal surgical procedures.
4.Previous periodontal plastic surgery.
5.Smokers patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Treatment of Multiple adjacent gingival recession by Modified Coronally Advanced Tunnel Technique using de-epithelialized free gingival graft Versus sub epithelial connective tissue graft |
Baseline,1 month and 3months |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="1"
Months="0"
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
|
The purpose of the study is to treat the gingival recession by modified coronally advanced tunnel technique using de-epithelialized free gingival graft versus subepithelial connective tissue graft. There was no significant differences between the two treatment modalities. |