FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/08/093282 [Registered on: 19/08/2025] Trial Registered Prospectively
Last Modified On: 18/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of thin gums for preventing gum recession and loss of teeth by increasing gum thickness  
Scientific Title of Study   Gingival phenotypic modification using recombinant human fibroblast growth factor -2 impregnated scaffold - A randomised 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 Saravanan SP 
Designation  AssistantProfessor 
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

South
DELHI
110010
India 
Phone  9637110906  
Fax    
Email  saravananacademics@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Saravanan SP 
Designation  AssistantProfessor 
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


DELHI
110010
India 
Phone  9637110906  
Fax    
Email  saravananacademics@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Saravanan SP 
Designation  AssistantProfessor 
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


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  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Lt Col Saravanan SP  Army Dental Centre Research and Referral  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  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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   Autogenous connective tissue graft will be used as soft tissue graft for gingival phenotypic modification of thin gingival phenotype in patients undergoing fixed orthodontic therapy will be followed up to 12 months 
Intervention  Intervention  Recombinant human fibroblast growth factor impregnated collagen scaffold will be used as soft tissue substitute for gingival phenotypic modification of thin gingival phenotype in patients undergoing fixed orthodontic therapy will be followed up to 12 months 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Thin gingival phenotype
Mandibular anterior region with respect to central incisors
FMBS less than 20
FMPS less than 20 
 
ExclusionCriteria 
Details  Smokers
Tobacco users
Pregnancy
Lactating mothers
Not available for 12 months follow up Unwilling for periodic recall every 3 months 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Changes in gingival soft tissue height Changes in keratinised tissue 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)   15/10/2025 
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 incorporated into a collagen scaffold offers a biomimetic, cell-stimulating alternative to autogenous connective tissue graft for gingival soft tissue phenotype modification. While connective tissue graft remains the gold standard for increasing gingival thickness and keratinized tissue width due to its predictable integration and volume stability, it is associated with donor site morbidity and limited tissue availability. rhFGF collagen scaffolds eliminate the need for a second surgical site and actively promote fibroblast proliferation, angiogenesis, and extracellular matrix deposition, potentially achieving comparable gains in gingival thickness with reduced patient morbidity. However, long term clinical evidence is still more robust for connective tissue grafts and rhFGF collagen scaffolds are currently better positioned as minimally invasive regenerative adjuncts rather than full  replacements. Hence this clinical trial is planned to be conducted with this rationale and background.  
Close