| CTRI Number |
CTRI/2025/11/097410 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Treatments for Receding Gums: With and Without a Healing Membrane |
|
Scientific Title of Study
|
Mucosal Released–Coronally Advanced Flap With and Without Amniotic Membrane in Treating Multiple Gingival Recession Defects: A Split-Mouth 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 |
Dr Gitanjali P |
| Designation |
Post Graduate Student |
| Affiliation |
Manipal College of Dental College Mangalore |
| Address |
Room no 7 4th floor Manipal College of Dental Sciences Kasturba Medical College Lighthouse hill road Hampankatta Mangalore
KARNATAKA
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
7353196259 |
| Fax |
|
| Email |
gpoddar1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mranali K Shetty |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental College Mangalore |
| Address |
Room no 7 4th floor Manipal College of Dental Sciences Kasturba Medical College Lighthouse hill road Hampankatta Mangalore
KARNATAKA
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9611016900 |
| Fax |
|
| Email |
mranali.shetty@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mranali K Shetty |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Dental College Mangalore |
| Address |
Room no 7 4th floor Manipal College of Dental Sciences Kasturba Medical College Lighthouse hill road Hampankatta Mangalore
KARNATAKA
India
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9611016900 |
| Fax |
|
| Email |
mranali.shetty@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of dental Sciences, Affiliate of manipal academy of higher education, lighthouse hill road , hampankatta mangalore Karnataka. 575001 |
|
|
Primary Sponsor
|
| Name |
Gitanjali P |
| Address |
Department of Periodontology, Room no. 7, 4th floor, Manipal college of dental sciences, Kasturba Medical College, lighthouse hill road, Hampankatta, Mangalore. Karnataka 575001
|
| Type of Sponsor |
Other [Self] |
|
|
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 GITANJALI P |
Manipal College of Dental Sciences Mangalore |
Dept. Of Periodontology, room no. 7, 4th floor, Manipal College of Dental Sciences, light house hill road, hampankatta, Mangalore, Karnataka, 575001
Dakshina Kannada
KARNATAKA |
7353196259
gpoddar1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K089||Disorder of teeth and supporting structures, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MUCOSAL RELEASED CORONALLY ADVANCED FLAP WITH AMNION MEMBRANE. |
Oblique incision will be placed and then sulcular incision with respect to the recession tooth. split full split thickness flap will be elevated and then one horizontal incision will be given in vestibule region wrt to the recession tooth. The amnion membrane will be placed wrt to the surgical site. The flap will be pulled coronally and sling suture will be placed and periodontal pack should be placed . Patient will be recalled after 14 days days for follow up and next the pt. will be recalled on 3rd month and 6th month. |
| Intervention |
MUCOSAL RELEASED CORONALLY ADVANCED FLAP WITHOUT AMNION MEMBRANE. |
Oblique incision will be placed and then sulcular incision with respect to the recession tooth. split full split thickness flap will be elevated and then one horizontal incision will be given in vestibule region wrt to the recession tooth. The flap will be pulled coronally and sling suture will be placed and periodontal pack should be placed . Patient will be recalled after 14 days days for follow up and next the pt. will be recalled on 3rd month and 6th month. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 20-55 years, irrespective of gender
2. Patients who agree to participate in the study by signing the informed consent
3. Systemically healthy patients having Miller’s class 1 and 2 recessions bilaterally in at least 2 maxillary teeth.
4. Full Mouth plaque Score – less than 25%
|
|
| ExclusionCriteria |
| Details |
1. Patients with aggressive periodontitis.
2. Known allergy to any of the materials
3. Chronic smokers
4. Patients with hypertension, diabetes or any other systemic disorders which affect the
outcome of the treatment.
5. Patients with bleeding and coagulation disorders
6. Pregnant and lactating mothers.
7. Patients with para functional habits.
8. Patients undergoing orthodontic treatment
9. Immunocompromised individuals
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recession height (RH)
Clinical attachment level (CAL)
Width of keratinized tissue (WKT
|
1, 3, 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Gingival thickness (GT)
•Plaque index (PI)
•Gingival index (GI)
|
1, 3, 6 months |
|
|
Target Sample Size
|
Total Sample Size="9"
Sample Size from India="9"
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)
|
22/11/2025 |
| 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="6"
Days="6" |
|
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 clinical trial aims to evaluate the effectiveness of the Mucosal Released-Coronally Advanced Flap (MR-CAF) technique with and without amniotic membrane in the treatment of multiple gingival recession defects. The study follows a randomized, single-blinded, split-mouth clinical trial design over 6 months. A total of 9 patients will be enrolled, and clinical parameters such as recession height, clinical attachment level, and width of keratinized tissue will be measured at baseline, 3 months, and 6 months. The trial seeks to compare healing outcomes, root coverage effectiveness, and patient morbidity between the two treatment modalities |