| CTRI Number |
CTRI/2025/05/087983 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Gum Recession with Cervical Lesions: Comparing PRF Membrane and Connective Tissue Graft with Resin-Modified Glass Ionomer Restorations. |
|
Scientific Title of Study
|
Comparative Evaluation of the Treatment of Gingival Recession Associated with Non-Carious Cervical Lesion by Coronally Advanced Flap in Conjunction with Platelet-Rich Fibrin Membrane or Connective Tissue Graft after Resin Modified Glass Ionomer Restoration: A clinical study. |
| 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 Sakshi Vishal Kotecha |
| Designation |
Post-Graduate Student |
| Affiliation |
Sharad Pawar Dental College. |
| Address |
Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research, Sawangi.
Wardha
MAHARASHTRA
442001
India |
| Phone |
09075340044 |
| Fax |
|
| Email |
drsakshikotecha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Professor |
| Affiliation |
Sharad Pawar Dental College. |
| Address |
Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research, Sawangi.
Wardha
MAHARASHTRA
442001
India |
| Phone |
09960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sakshi Vishal Kotecha |
| Designation |
Post-Graduate Student |
| Affiliation |
Sharad Pawar Dental College. |
| Address |
Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research, Sawangi.
Wardha
MAHARASHTRA
442001
India |
| Phone |
09075340044 |
| Fax |
|
| Email |
drsakshikotecha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sharad Pawar Dental College. |
| Address |
Datta Meghe Institute of Higher Education and Research. |
| 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 Sakshi Kotecha |
Sharad Pawar Dental College. |
Department of Periodontics, Sharad Pawar Dental College, Datta Meghe Institue of Higher Education and Research, Sawangi, Wardha, Maharashtra-442001
Wardha
MAHARASHTRA |
09075340044
drsakshikotecha@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: K031||Abrasion of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Coronally Advanced Flap in Conjunction with Connective Tissue Graft. |
CTG will be placed over RmGIC, and the flap will be placed coronally and flap closure will be done by coronally advanced flap technique. |
| Intervention |
Coronally Advanced Flap in Conjunction with Platelet-Rich Fibrin Membrane. |
PRF membrane will be placed over RmGIC and flap closure will be done by coronally advanced flap technique. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients motivated to have the therapy and complete follow up.
2.Subjects who readily give informed consent for the study.
3.Patients with a minimum number of fifteen teeth.
4.Good physical and systemic health.
5.Positive for the presence of cervical lesions associated with multiple gingival recessions in different adjacent teeth
6.Miller Class I or Class II gingival recession defect associated with buccal NCCL Class B + step,
7.NCCL depth 1–2 mm,
8.Presence of more than 1 mm highly keratinized tissue apical to the root exposure, and presence of more than 0.8 mm-thick gingival tissue. |
|
| ExclusionCriteria |
| Details |
1.Patients who had systemic problems that would contraindicate for periodontal surgery,
2.Taking medications known to interfere with periodontal tissue health or healing,
3.Presence of non-vital teeth, caries or restorations on cervical areas, severe occlusal interferences and previous surgery in the area.
4.Pregnant ladies and lactating mothers.
5.Chronic alcoholics. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Combined defect height (CDH), Non-carious cervical lesion height (CLH) and Non-carious cervical lesion width (CLW). |
1 week, 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing Pocket Depth, Clinical Attachment Level. |
1 week, 1 month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
15/08/2025 |
| 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="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
|
Gingival recession is an apical shift of the gingival margin with exposure of the root surface. Various treatment modalities have been advocated for non-carious cervical lesion (NCCL) of which conventional glass-ionomer materials were proposed as restorative materials for NCCL lesions. Recently, resin-modified glass-ionomer cement (RmGIC) came into existence owing to its superior physical properties than conventional glass-ionomers. Platelets have a vital role in periodontal regeneration due to the presence of growth factors and cytokines which are essential for maturation of soft tissue and regeneration of bone. Coronally advanced flap (CAF) is the ideal surgical procedure in the presence of sufficient keratinized gingiva apical to the recession defect. Therefore, the aim of study is to evaluate and compare the treatment of Gingival Recession Associated with Non-Carious Cervical Lesion by Coronally Advanced Flap in Conjunction with Platelet-Rich Fibrin Membrane or Connective Tissue Graft After Resin Modified Glass Ionomer Restoration. Patient will be recalled at 1 week, 1 month and 3 months. Statistical analysis will be done after obtaining resulting data. |