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CTRI Number  CTRI/2025/01/079520 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized Factorial Trial 
Public Title of Study   Evaluation of Effectiveness of Injectable Platelet-Rich Fibrin and 2% Hyaluronic Acid Gel for Non-Surgical Interdental Papilla Reconstruction 
Scientific Title of Study   EFFICACY AND COMPARATIVE EVALUTION OF INJECTABLE PLATELET RICH FIBRIN AND 2% HYALURONIC ACID GEL IN INTERDENTAL PAPILLA RECONSTRUCTION USING NON-SURGICAL APPROACH 
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 Nisha Parikh 
Designation  Resident Doctor (Periodontology) 
Affiliation  Dharmsinh Desai University 
Address  Department of Periodontology, Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad, Gujarat 387001

Kheda
GUJARAT
387001
India 
Phone  9978654932  
Fax    
Email  nishakekinparikh@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vasumati Patel 
Designation  Head of the Department 
Affiliation  Dharmsinh Desai University 
Address  Department of Periodontology, Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad, Gujarat 387001

Kheda
GUJARAT
387001
India 
Phone  8200210769  
Fax    
Email  pateldrvasu@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Dr Nisha Parikh 
Designation  Resident Doctor (Periodontology) 
Affiliation  Dharmsinh Desai University 
Address  Department of Periodontology, Faculty Of Dental Science, Dharmsinh Desai University, College Road, Nadiad, Gujarat 387001

Kheda
GUJARAT
387001
India 
Phone  9978654932  
Fax    
Email  nishakekinparikh@gmail.com  
 
Source of Monetary or Material Support  
Dharmsinh Desai University, Faculty of Dental Science, College Road, Nadiad, Gujarat 387001 
 
Primary Sponsor  
Name  Dharmsinh Desai University 
Address  Dharmsinh Desai University, Faculty of Dental Science, College Road, Nadiad, Gujarat 387001 
Type of Sponsor  Research institution 
 
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 Nisha Parikh  Dharmsinh Desai University  Department of Periodontology, Faculty Of Dental Science, College Road, Nadiad, Gujarat 387001
Kheda
GUJARAT 		 09978654932

nishakekinparikh@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Faculty of Dental Science, Dharmsinh Desai University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyaluronic Acid Gel (HA Gel)  Once adequate anaesthesia will be obtained the deficient papilla will be injected with 2% HA gel (HYADENT BG)® using a prefilled insulin syringe. The needle will be inserted 2-3 mm apical to the tip of the interdental papilla and directed coronally with an angulation of 45° to the long axis of the tooth, and the bevel directed apically. Then, the papilla will be lightly moulded in an incisal direction for 1 minute using gauze.  
Comparator Agent  Injectable Platelet Rich Fibrin (i-prf)  Injectable Platelet Rich Fibrin (i-prf) will be prepared using Choukrouns method. Obtained i-PRF will be filled in the insulin syringes which becomes ready to use at the desired site. Once adequate anesthesia will be obtained the needle of the insulin syringe filled with i-prf will be inserted 2–3 mm apical to the Papilla Tip directed coronally making an angle of 45° to the long axis of the tooth with its bevel facing apically. Post injection, the papilla will be gently massaged in an incisal direction, for a minute using a gauze piece.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Healthy subjects with both genders having age more than 18 years;
2. Patient complaint of food lodgment or esthetic consciousness for open gingival embrasure;
3. Presence of at least one site with Class 1 or Class 2 recession (according to Norland and Tarnow’s classification system) of the papilla in the maxillary and mandibular anterior region;
4. Patients having adequate zone of attached gingiva at the selected region; and
5. Patient having minimal probing depth (less than equal to 3 mm) at the deficient papillary sites.
 
 
ExclusionCriteria 
Details  1. Teeth with caries, proximal restorations on the cervical (buccal or proximal) region, fixed prosthesis or orthodontic appliances;
2. Teeth with open contacts, interdental spacing, crowding, proclination, rotation, or alveolar bone loss;
3. Patients with active periodontal diseases and poor oral hygiene;
4. Patients having gingival recession on the labial surface of the teeth adjacent to the open embrasure;
5. Patients under orthodontic treatment or had orthodontic treatment in the past six months;
6. Patients with high frenum attachment;
7. Patients with history of allergic reactions, pregnant or breastfeeding females, smokers and alcoholics;
8. Patients having bleeding disorders;
9. Patients with medical conditions that may affect periodontal healing or regeneration.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Papillary fill, Height of Interdental papilla (Nordland and Tarnow’s classification), Papillae Index Score (PIS) – (Nemcovsky’s classification), Clinical Measurement: CP-PT Distance (Distance from the Contact Point to Papillary Tip).  Baseline, 1 month and 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival index, Probing depth, Verbal analogue scale for pain and discomfort   Baseline, 1 month and 3 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   20/02/2025 
Date of Study Completion (India) 30/05/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 30/05/2025 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  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 [nishakekinparikh@gmail.com].

  6. For how long will this data be available start date provided 20-09-2025 and end date provided 20-09-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study shall compare the effectiveness of Hyaluronic Acid Gel and Injectable Platelet Rich Fibrin for nonsurgical interdental papilla reconstruction in individuals with loss of interdental papilla. It will be conducted as a randomized, split mouth clinical trial involving 30 sites with loss of interdental papilla who meet the specified inclusion criteria. Various clinical parameters, including Papillary Fill, Height of Interdental Papilla (Norland and Tarnow’s Classification), Papilla Index Score (Nemcovsky’s classification), CP-PT Distance (Distance from the Contact Point to Papillary Tip), Gingival Index, Probing Depth, Verbal Analogue Scale for Pain and Discomfort, will be evaluated at baseline and over follow-up periods. The research aims to identify which material  offers superior outcomes regarding Papillary Fill, and Healing. The findings will contribute to improving clinical decision making, providing dentists with evidence based recommendations for selecting the most suitable material. This research has the potential to advance interdental papilla reconstruction using nonsurgical approach by optimizing patient care, minimizing discomfort, and ensuring papillary fill for sites with interdental papilla loss. 
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