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CTRI Number  CTRI/2023/07/055307 [Registered on: 17/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Other 
Public Title of Study   Injectable 2% Hyaluronic acid vs i-PRF for reconstruction of lost interdental papilla. 
Scientific Title of Study   Comparative evaluation of 2% injectable Hyaluronic acid versus i-PRF for reconstruction of lost interdental papilla : A Randomized 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  MOHAMMED ASHIF K 
Designation  Post graduate student 
Affiliation  Yenepoya Dental College 
Address  Room no 7, 2nd floor , Department of Periodontology, Yenepoya Dental College, Yenepoya University, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9846580917  
Fax    
Email  23426@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr. Vinita A Boloor 
Designation  Additional Professor 
Affiliation  Yenepoya Dental College 
Address  Room no 7, 2nd floor , Department of Periodontology, Yenepoya Dental College, Yenepoya University, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9845114652  
Fax    
Email  drvinitaboloor@gmail.com  
 
Details of Contact Person
Public Query  
Name  MOHAMMED ASHIF K 
Designation  Post graduate student 
Affiliation  YENEPOYA DENTAL COLLEGE 
Address  Room no 7, 2nd floor , Department of Periodontology, Yenepoya Dental College, Yenepoya University, Mangalore

Dakshina Kannada
KARNATAKA
575018
India 
Phone  9846580917  
Fax    
Email  23426@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Department of Periodontology, Yenepoya Dental College, Yenepoya University.  
 
Primary Sponsor  
Name  Mohammed Ashif 
Address  Yenepoya Dental College, Deralakatte, Mangalore, Karnataka -575018 
Type of Sponsor  Other [Self funded] 
 
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 
Mohammed Ashif  Yenepoya Dental college and hospital, Yenepoya University,  Room No 7, 2nd floor, Department of Periodontology.
Dakshina Kannada
KARNATAKA 		 9846580917

23426@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Lost interdental papilla 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases, (2) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  2% Hyaluronic Acid Injection  Oral prophylaxis will be done. The area will be anaesthetised with a local infiltration Lignocaine hydrochloride and 2% adrenaline 1in 80,000 injection (XICAINE®). 0.2 ml of HA filler (20 mg/ml concentration) will be injected at the respective sites 2–3 mm apical to the coronal tip of papillae with a needle at a 45° angle. This procedure will be done once at the baseline. 
Intervention  i-PRF   Oral Prophylaxsis will be done. i-PRF will be prepared for each patient as follows: 10 ml of venous blood will be collected from the patient right before the intervention. Collected blood will be placed in a i-PRF tube without any added material or coagulant and centrifuged using Duo Quattro® at 700 rpm for 3 minutes. i-PRF will be transferred to a marked 27G insulin syringe. The area will be anasthetised with a local infiltration Lignocaine hydrochloride and 2% adrenaline 1in 80,000 injection (XICAINE®). i-PRF will be injected at the respective sites 2-3mm apical to the tip of papillae with a 27G insulin syringe. This procedure will be done once at the baseline. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Systemically healthy participants.
2.Class I or class II papilla according to Nordland and Tarnow’s Classification system for loss of papillary height.
3.Loe and Silness gingival index less than or equal to 1. 
 
ExclusionCriteria 
Details  1. Participants using any form of tobacco.
2. Pregnant or lactating females.
3. Participants who are already on anti-inflammatory or anti-bacterial drugs.
4. Participants using a drug which has influence in gingival growth.
5. Participants with midline diastema / loss of proximal contact.
6. Participants with untreated maxillary anterior caries, prosthesis and orthodontic appliances. 
 
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 
To assess the amount of papillary fill in the maxillary anterior region in the following groups of participants at the end of 3rd month,
Group 1 with 2% Hyaluronic Acid
Group 2 with i-PRF. 		 Baseline, at the end of 1 month and at the end of 3rd month. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of injectable platelet-rich fibrin (i-PRF) in the reconstruction of lost interdental papilla.  At baseline, end of 1st and 3rd month 
To compare the effectiveness of 2% HA and i-PRF in the reconstruction of lost interdental papilla.  At baseline, endo of 1st and 3rd month 
 
Target Sample Size   Total Sample Size="14"
Sample Size from India="14" 
Final Enrollment numbers achieved (Total)= "14"
Final Enrollment numbers achieved (India)="14" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/07/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 18/04/2025 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The interdental papilla is the gingival area that occupies the interproximal zone below the contact point between two adjacent teeth. In addition to having a positive effect on smile aesthetics, interdental papillae are important in preventing food impaction between teeth and contribute to improved phonetics.A deficient interdental papilla is known as the black triangle which can result from several factors, e.g. the age of the subject, the shape/size of teeth, the length of the proximal contact point, and the interproximal gingival thickness.

 

Different treatment options are often proposed to close an open gingival embrasure, such as orthodontics or restorative, surgical and prosthetic care. However these methods are known to be invasive and unpredictable. Therefore minimally invasive techniques like 2% HA and i-PRF has been found to be effective and also most frequently used for the reconstruction of the lost interdental papilla.

As the HA and the i-PRF share similar properties in terms of promoting periodontal regeneration, collagen synthesis, and wound healing[7]. This study aimed to evaluate and compare the effectiveness of 2% injectable hyaluronic acid and i-PRF in the reconstruction of lost interdental papilla.

This study will include 14 systemically healthy participants, who meet the selection criteria ,reporting to the Department of Periodontology. Ethical clearance will be obtained and all the participants will b e subjected to oral prophylaxis before the study begins. The participants will be randomly allotted into one of the two study groups.

â–ª Group 1: For injectable 2% HA treatment protocol.
â–ª Group 2: For i-PRF protocol.

Clinical parameters such as (contact point to papillary tip [CP-PT] will be recorded using UNC 15 probe and standardized photographs taken for ImageJ software analysis) will be recorded at baseline, at the end of 1st and 3rd month , using these parameters the papillary fill will be evaluated.

 
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