| CTRI Number |
CTRI/2025/08/093190 [Registered on: 18/08/2025] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| 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 pyorrhoea associated bone loss around teeth using gel |
|
Scientific Title of Study
|
Efficacy of recombinant human fibroblast growth factor gel in the management of intrabony defects - A randomised controlled, double blinded, 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 |
Lt Col Saravanan 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
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 |
Lt Col Saravanan 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
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 |
Lt Col Saravanan 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
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 |
| DrSaravanan SP |
Army Dental Centre Research and Referra |
Room No 205 First Floor Dept of Periodontology Delhi Cantonment 110010 South
DELHI
South
DELHI |
9637110906
saravananacademics@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Army Dental Centre Research and Referral |
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 |
| Comparator Agent |
Control Group |
Placebo gel will be used as a biological agent for treatment of isolated intrabony defects in mandible combination with open flap debridement will be performed and the patient will be followed up to 12 months |
| Intervention |
Test group |
Recombinant human fibroblast growth factor gel will be used as a biological agent for treatment of isolated intrabony defects in mandible combination with open flap debridement will be performed and the patient will be followed up to 12 months |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
With single intrabony defect
In posterior mandible sites
Sufficient soft tissue height and thickness at the defect site
|
|
| ExclusionCriteria |
| Details |
Smokers
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 |
Radiographic bone fill
Reduction in pocket probing depth
Gain in clinical attachment level |
Baseline, 3 Months, 6 Months, 12 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Longevity of tooth survival
Reduction in mobility
Incidence of complications
Patient reported outcome measures |
Baseline, 3 Months, 6 Months, 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)
|
01/10/2025 |
| 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 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
|
Recombinant human fibroblast growth factor has demonstrated significant regenerative potential in the management of intrabony periodontal defects. By stimulating the proliferation of periodontal ligament cells, cementoblasts, and osteoblasts, rhFGF promotes the regeneration of key periodontal structures, including alveolar bone, cementum, and connective tissue attachment. Clinical studies have reported improved clinical attachment levels, reduced probing depths, and significant radiographic bone fill when rhFGF is used alone or in combination with scaffolds such as collagen or beta TCP. Its angiogenic and mitogenic properties make rhFGF a potent therapeutic agent for enhancing periodontal regeneration in intrabony defects. |