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CTRI Number  CTRI/2025/08/092612 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Improving gum surgery results with Hyaluronic acid: A study on bone healing  
Scientific Title of Study   EFFICACY OF OPEN FLAP DEBRIDEMENT WITH 0.8% HYALURONIC ACID IN TREATMENT OF INTRABONY DEFECTS: A 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 Narayani Singh 
Designation  Postgraduate Student  
Affiliation   
Address  Room no.3, Department of Periodontology, Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road.

Moradabad
UTTAR PRADESH
244001
India 
Phone  8840559221  
Fax    
Email  narayanisingh1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anubha Nirwal  
Designation   
Affiliation   
Address  Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road.

Moradabad
UTTAR PRADESH
244001
India 
Phone    
Fax    
Email  anubhanirwalperio@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Narayani Singh 
Designation  Junior Resident 1  
Affiliation   
Address  Room no.3, Department of Periodontology, Kothiwal Dental College and Research Centre, Mora Mustaqueem, Kanth Road.

Moradabad
UTTAR PRADESH
244001
India 
Phone  8840559221  
Fax    
Email  narayanisingh1998@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Kothiwal dental college and research centre 
Address  Kothiwal dental college and research centre, Haridwar Road, Mohra Ki Milak, Moradabad, Uttar Pradesh 244001 
Type of Sponsor  Research institution and hospital 
 
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 Narayani Singh  Kothiwal Dental College and Research Centre  Room no.3, Department of Periodontology, Moradabad, Uttar Pradesh
Moradabad
UTTAR PRADESH 		 8840559221
-
narayanisingh1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KOTHIWAL DENTAL COLLEGE AND RESEARCH CENTRE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Poor oral health conditions exhibiting Vertical Bone Defects.  
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  0.8% Hyaluronic acid gel with open flap debridement in treating intrabony vertical defects.   Hyaluronic acid (0.8% concentration) gel syringes (Periobiologics LLP, Hyderabad, Telangana, India) with a molar mass between 1000 Da to 10 MDa. Duration- 45 minutes. 
Intervention  Open flap debridement in treating intrabony vertical defects.   Open flap debridement surgery will be performed at intrabony vertical defect sites. Duration- 45 minutes.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Probing pocket depth greater than or equal to 5 mm.
2. Clinical attachment loss greater than or equal to 3 mm.
3. Sites exhibiting evidence of intrabony defects of minimum 3 mm dimension as observed through Cone beam computed tomography (CBCT).  
 
ExclusionCriteria 
Details  1. Subjects who went through periodontal therapy within the previous year.
2. Subjects taking any medication which can influence the gingival response during healing.
3. Subject with any systemic disease affecting periodontium.
4. Pregnant women and lactating mothers.
5. Subjects with blood dyscrasia or bleeding disorder.
6. Smokers and tobacco chewers.
7. Subjects who cannot perform routine oral hygiene procedures or do not comply with oral hygiene instructions.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Probing pocket depth
2. Clinical attachment level
3. Early healing index
 		 1. Probing pocket depth at baseline, 3 months, 6 months
2. Clinical attachment level at baseline, 3 months, 6 months
3. Early healing index after 7 days
 
 
Secondary Outcome  
Outcome  TimePoints 
1. Intrabony defect bone fill and the crestal level of bone, using Cone beam computed tomography (CBCT).
To compare results obtained in test and control groups.  		 1. Intrabony defect bone fill and the crestal level of bone, using Cone beam computed tomography(CBCT) at baseline and 6 months.  
 
Target Sample Size   Total Sample Size="32"
Sample Size from India="32" 
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)   18/08/2025 
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="2"
Months="0"
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 - 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 [narayanisingh1998@gmail.com].

  6. For how long will this data be available start date provided 10-10-2025 and end date provided 12-12-2026?
    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 randomized controlled clinical trial aims to evaluate the efficacy of open flap debridement (OFD) with 0.8% hyaluronic acid (HA) in the treatment of periodontal intrabony defects. Thirty-two sites in patients with chronic periodontitis will be randomly assigned into two groups: Group A (OFD alone) and Group B (OFD with 0.8% HA). Clinical parameters like probing pocket depth (PPD), clinical attachment level (CAL), and early healing index (EHI), along with radiographic evaluation of bone fill and crestal bone level using cone-beam computed tomography (CBCT), will be recorded at baseline, 3 months, and 6 months. The study aims to determine whether adjunctive HA offers additional regenerative benefits over OFD alone.

Hyaluronic acid is a biocompatible, biodegradable glycosaminoglycan with proven wound healing, anti-inflammatory, and osteogenic properties. It has shown promising outcomes in periodontal regeneration by promoting soft tissue healing, enhancing angiogenesis, and facilitating bone regeneration. However, based on previous literature, this study expects superior clinical and radiographic outcomes in the HA group. This trial will help establish the adjunctive role of HA in regenerative periodontal surgery and may offer a minimally invasive, biomimetic approach for the management of periodontal intrabony defects. 
 
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