FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/03/083146 [Registered on: 24/03/2025] Trial Registered Prospectively
Last Modified On: 21/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical trial to study the effects of hyaluronic acid, i- PRF and combination of both on patients with thin periodontal phenotype  
Scientific Title of Study   Evaluation of efficacy of hyaluronic acid, i-PRF and combination of both through VISTA approach in the management of thin periodontal phenotype- A Randomized clinical trial ( RCT)  
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 Vinita Kothari 
Designation  Post graduate student 
Affiliation  Jawahar Medical Foundations Annasaheb Chaudaman Patil Memorial dental college, Dhule 
Address  Department of Periodontology, Room no.3, Annasaheb Chaudaman Patil Memorial dental college, sakri road, Dhule, tal.Dist- Dhule, Affiliated to MUHS Nashik.

Dhule
MAHARASHTRA
424001
India 
Phone  08975154333  
Fax    
Email  vinitakothari1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anuradha Bhatsange 
Designation  Professor 
Affiliation  Jawahar Medical Foundations Annasaheb Chaudaman Patil Memorial dental college, Dhule 
Address  Department of Periodontology, Room no.3, Annasaheb Chaudaman Patil Memorial dental college, sakri road, Dhule, tal.Dist- Dhule, Affiliated to MUHS Nashik.

Dhule
MAHARASHTRA
424001
India 
Phone  7020927361  
Fax    
Email  anujaps219@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anuradha Bhatsange 
Designation  Professor 
Affiliation  Jawahar Medical Foundations Annasaheb Chaudaman Patil Memorial dental college, Dhule 
Address  Department of Periodontology, Room no.3, Annasaheb Chaudaman Patil Memorial dental college, sakri road, Dhule, tal.Dist- Dhule, Affiliated to MUHS Nashik.

Dhule
MAHARASHTRA
424001
India 
Phone  7020927361  
Fax    
Email  anujaps219@gmail.com  
 
Source of Monetary or Material Support  
Jawahar Medical Foundations, Annasaheb Chaudaman Patil Memorial dental college, Department of Periodontology, room no 3, Sakri road, Dhule 424001 Maharashtra, India 
 
Primary Sponsor  
Name  Dr Vinita Kothari 
Address  Jawahar Medical Foundations, Annasaheb Chaudaman Patil Memorial dental college, Department of Periodontology, room no 3, Sakri road, Dhule 424001, Maharashtra, India 
Type of Sponsor  Other [Self] 
 
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 
Dr Vinita Kothari  Annasaheb Chudaman Patil Memorial dental college  Department of Periodontology, Room no.3, Annasaheb Chaudaman Patil Memorial dental college, sakri road, Dhule, tal.Dist- Dhule 424001, Maharashtra, India. Affiliated to MUHS Nashik.
Dhule
MAHARASHTRA 		 08975154333

vinitakothari1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JMFs ACPM dental college, Dhule Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: K055||Other periodontal diseases, (3) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyaluronic acid  1.5 % injectable hyaluronic acid 0.25 ml per site 
Intervention  i- PRF  Injectable PRF got by centrifuging 5 ml patients blood at 700 rpm for 4 minutes 
Intervention  i- PRF + 1.5% hyaluronic acid  Injectable PRF got by centrifuging 5 ml patients blood at 700 rpm for 4 minutes and 1.5% injectable Hyaluronic acid 0.25 ml per site 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Participants diagnosed with thin gingival phenotype. gingival thickness less than or equal to 1 mm
2 Participants willing to participate in the study 
 
ExclusionCriteria 
Details  1 Systemically compromised patients
2 Heavy smokers
3 Pregnant or lactating woman
4 Patients who have been previously undergone periodontal therapy
5 Patients with active orthodontic treatment
6 Aggressive or chronic periodontitis
7 Patients with known allergy to hyaluronic acid 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Hyaluronic acid, i-PRF and combination of both through VISTA approach on thin periodontal phenotype.  Gingival thickness, Keratinized tissue width at time points baseline, 1 month, 3 months and 6 months. Buccal bone thickness at time points baseline and six months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Hyaluronic acid through VISTA approach in the management of thin periodontal phenotype
To evaluate the efficacy of i-PRF through VISTA approach in the management of thin periodontal phenotype
To evaluate the efficacy of combination of hyaluronic acid and i-PRF through VISTA approach in the management of thin periodontal phenotype
 		 Gingival thickness, Keratinized tissue width, Plaque index, Gingival index, Bleeding on probing, Probing depth and Clinical attachment level time point-baseline, one month, three months and six months.
Buccal bone thickness at crest and at midbuccal level time point- baseline and 6 months 
 
Target Sample Size   Total Sample Size="69"
Sample Size from India="69" 
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 3/ Phase 4 
Date of First Enrollment (India)   02/04/2025 
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="4"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vinitakothari1998@gmail.com].

  6. For how long will this data be available start date provided 21-03-2025 and end date provided 21-06-2026?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary     This is a randomized clinical trial, which studies effects of  1.5% hyaluronic acid, i- PRF and combination of both on thin periodontal phenotype through VISTA approach for gingival thickness, keratinized tissue width and buccal bone thickness. The study evaluates primary hypothesis as is there difference in efficacy of hyaluronic acid, i-PRF and combination of both through VISTA approach in the management of thin periodontal phenotype in terms of gingival thickness, keratinized tissue width and buccal bone thickness.
  The primary outcome measures will be increase in gingival thickness, keratinized tissue width and buccal bone thickness. Improvement in gingival index, plaque index, bleeding on probing, probing pocket depth and clinical attachment levels will be secondary outcome that will be measured at baseline, one month, three months and six months. Buccal bone thickness will be measured at baseline and six months.
 
Close