| CTRI Number |
CTRI/2025/07/091569 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Treatment of gum recession using growth factor therapy |
|
Scientific Title of Study
|
Efficacy of recombinant human fibroblast growth factor impregnated scaffold in the management of isolated maxillary gingival recession - A randomised 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 |
DrSaravanan SP |
| Designation |
Assistant Professor |
| Affiliation |
Army Dental Centre Research Referral Delhi |
| Address |
Room No 205
First Floor
Dept of Periodontology
Army Dental Centre Research and Referral
Delhi India
Army Dental Centre Research and Referral
Delhi India
South
DELHI
110010
India |
| Phone |
9637110906 |
| Fax |
|
| Email |
saravananacademics@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSaravanan SP |
| Designation |
Assistant Professor |
| Affiliation |
Army Dental Centre Research Referral Delhi |
| Address |
Room No 205
First Floor
Dept of Periodontology
Army Dental Centre Research and Referral
Delhi India
Army Dental Centre Research and Referral
Delhi India
DELHI
110010
India |
| Phone |
9637110906 |
| Fax |
|
| Email |
saravananacademics@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSaravanan SP |
| Designation |
Assistant Professor |
| Affiliation |
Army Dental Centre Research Referral Delhi |
| Address |
Room No 205
First Floor
Dept of Periodontology
Army Dental Centre Research and Referral
Delhi India
Army Dental Centre Research and Referral
Delhi India
DELHI
110010
India |
| Phone |
9637110906 |
| Fax |
|
| Email |
saravananacademics@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Dental Centre Research and Referral
Dhaula Kuan
Delhi Cantonment
Delhi
110010 |
|
|
Primary Sponsor
|
| Name |
Indian Army |
| Address |
Director General Armed Forces Medical Services
Room A402
Block A
4th Floor
Africa Avenue
New Delhi
110023 |
| Type of Sponsor |
Government funding agency |
|
|
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 Saravanan SP |
Army Dental Centre Research and Referral |
Room No 205
First Floor
Dept of Periodontology
Delhi Cantonment
110010
South
DELHI |
9637110906
saravananacademics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army Dental centre |
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 |
| Comparator Agent |
Control |
Collagen scaffold with placebo impregnation will be used for management of isolated maxillary gingival recession in combination with coronally advanced flap will be performed and the patient will be followed up to 12 months |
| Intervention |
FGF group |
Recombinant human fibroblast growth factor impregnated collagen scaffold will be used as soft tissue substitute for treatment of isolated gingival recession in maxilla in combination with coronally advanced flap will be performed and the patient will be followed up to 12 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
RT1 type recession
Maxillary gingival recession
Isolated gingival recession
Thin soft tissue phenotype
FMBS less than 20
FMPS less than 20 |
|
| ExclusionCriteria |
| Details |
mokers
Tobacco users
Pregnancy
Lactating mothers
Not available for 24 months follow up
Unwilling for periodic recall every 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in recession height
Changes in recession width
Mean root coverage
Complete root coverage
Visual analog scale
Patient reported outcome measures |
Baseline, 3 Months, 6 Months, 9 Months, 12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction
Incidence of complications |
0,3,6,9,12 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="1"
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
|
Recombinant human fibroblast growth factor (rhFGF) has shown promising results in the treatment of isolated maxillary gingival recession defects. When used in conjunction with a coronally advanced flap or biomaterials like collagen membranes, rhFGF enhances angiogenesis, promotes fibroblast proliferation, and accelerates periodontal tissue regeneration. Clinical outcomes demonstrate improved root coverage, increased keratinized tissue width, and superior soft tissue aesthetics, making rhFGF a valuable adjunct in regenerative periodontal therapy for localized recession. However there is no single study available on this in India. Hence this clinical trial. |