| CTRI Number |
CTRI/2026/01/101429 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
19/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of treating receding gums with or without a special collagen healing membrane |
|
Scientific Title of Study
|
Efficacy of Fibroblast Growth Factor-2 (Fgf-2) Impregnated Collagen Membrane as an adjunct to Coronally Advanced Flap in the treatment of Gingival Recession: A Randomized Controlled 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 Richa Singh |
| Designation |
Post graduate student |
| Affiliation |
Institute of Dental Studies and Technologies, |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar UP
Institute of Dental Studies and Technologies Kadrabad Modinagar UP
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
07251063788 |
| Fax |
|
| Email |
richasingh0299@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mansi Bansal |
| Designation |
Professor and Head |
| Affiliation |
Institute of Dental Studies and Technologies, |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar UP
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar UP
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9871655313 |
| Fax |
|
| Email |
drmansibansal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manish Khatri |
| Designation |
Professor |
| Affiliation |
Institute of Dental Studies and Technologies, |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar UP
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar UP
Ghaziabad
UTTAR PRADESH
201201
India |
| Phone |
9810720335 |
| Fax |
|
| Email |
drmanishkhatri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar UP |
|
|
Primary Sponsor
|
| Name |
Institute of Dental Studies Technologies |
| Address |
Department of Periodontology Institute of Dental Studies and Technologies Kadrabad Modinagar UP- 201201 |
| 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 Richa Singh |
Institute of Dental Studies and Technologies |
Institute of Dental Studies and Technologies, Department of Periodontology, Room number 7, NH-58, Delhi-Meerut Road,
Kadrabad, Modinagar, Uttar
Pradesh, India-201201 Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH |
7251063788
richasingh0299@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coronally advanced flap |
CAF (Coronally advanced flap) is a highly effective and versatile surgical technique which is known for its ability to achieve predictable and stable root coverage, making it a preferred option in both isolated and multiple Gingival recession cases. |
| Comparator Agent |
Coronally advanced flap with Fibroblast Growth Factor-2 (FGF-2) impregnated collagen membrane. |
FGF are a family of proteins that signal cells to perform a variety of functions, when FGF combined with collagen membrane have potential in the early healing phase by achieving predictable root coverage outcomes. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Patients having Cairo RT1/RT2 gingival recession defect.
Patients compliant to maintain good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
Patient having Habit of Smoking
Immunocompromised patients
Pregnant and Lactating women
Previously treated periodontal surgery in last 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
With the use of stentProbing Pocket Depth (PPD): [(FRP-BOP) -(FRP-GM)]
Clinical Attachment Level (CAL): [(FRP-BOP)- (FRP-CEJ)]
Gingival Recession (GR): [(FRP-GM)-(FRP-CEJ)]
Width of Keratinized Gingiva (KT): [(FRP-MGJ)-(FRP-GM)]
Without the use of stent-
1.Width of Recession (At CEJ) |
Baseline, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Root Coverage Esthetic Score (RES) and
percentage of Root Coverage. |
baseline and 6 months |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
30/01/2026 |
| 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="2"
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
|
This study
was conducted and compiled by Dr. Richa Singh, Dr. Mansi Bansal, Dr.
Manish Khatri, Dr Pratiksha Tripathi, Dr. Mohd. Rehan at
Department of Periodontology, Institute of Dental Studies
and Technologies, Kadrabad, Modinagar, Uttar Pradesh, India. The study is
a randomized control trial for comparison of coronally advanced flap
with and without Fibroblast Growth Factor-2 (FGF-2) impregnated collagen
membrane in treatment of gingival recession. |