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CTRI Number  CTRI/2025/04/085597 [Registered on: 24/04/2025] Trial Registered Prospectively
Last Modified On: 11/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Gum reconstruction by using injectable hyaluronic acid 
Scientific Title of Study   Evaluation of efficacy of injectable hyaluronic acid in reconstruction of interdental papilla 
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 Parveen Dahiya 
Designation  Professor 
Affiliation  Department of Periodontics and Implantology Himachal Institute of Dental Sciences , Paonta Sahib 
Address  Department of Periodontics and Implantology room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh

Sirmaur
HIMACHAL PRADESH
173025
India 
Phone  9857373300  
Fax    
Email  parveen_132@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Parveen Dahiya 
Designation  Professor 
Affiliation  Department of Periodontics and Implantology Himachal Institute of Dental Sciences , Paonta Sahib 
Address  Department of Periodontics and Implantology room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh

Sirmaur
HIMACHAL PRADESH
173025
India 
Phone  9857373300  
Fax    
Email  parveen_132@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Parveen Dahiya 
Designation  Professor 
Affiliation  Department of Periodontics and Implantology Himachal Institute of Dental Sciences , Paonta Sahib 
Address  Department of Periodontics and Implantology room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh

Sirmaur
HIMACHAL PRADESH
173025
India 
Phone  9857373300  
Fax    
Email  parveen_132@yahoo.com  
 
Source of Monetary or Material Support  
Department of Periodontics and Implantology room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh District-Sirmaur Pin code 173025 
 
Primary Sponsor  
Name  Parveen Dahiya 
Address  Department of Periodontics and Implantology room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh District- Sirmaur Pin code 173025 
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 Sagarika Surya  Himachal institute of dental sciences, paonta sahib  Department of Periodontics and Implantology room no 4 Himachal Institute of Dental Sciences Paonta Sahib Himachal Pradesh District- Sirmaur Pin code 173025
Sirmaur
HIMACHAL PRADESH 		 8077762039

sagarika.surya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
HIDS Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontal Condition 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Distilled water  Distilled water 
Intervention  Hyaluronic Acid  Sodium Hyaluronate E.P 20mg/2ml Excipients: Sodium Chloride, monobasic sodium phosphate dihydrate, Dibasic sodium phosphate dodecahydrate, Water for injections q.s to 2 ml 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Non-smoking patient.
Had at least one site with interdental papilla recession in the anterior region of the maxillary and mandibular jaws.
No active periodontal diseases and good oral hygiene. 
 
ExclusionCriteria 
Details  If patient have spacing or crowding between the teeth to be treated, abnormal tooth shape, systemic diseases such as diabetes mellitus, hypertension or conditions that alter the outcome of periodontal therapy.
Pregnant and lactating women and tobacco users excluded. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
inter-papillary regeneration  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
subject perspective towards esthetic zone  3 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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   N/A 
Date of First Enrollment (India)   15/05/2025 
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="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
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  

This study will investigate the effect of hyaluronic acid gel injections on interdental papilla without comparing it to other treatments. The effectiveness will be evaluated over a three-month period by measuring the reduction in black triangle height using photographic analysis. Hyaluronic acid, a nonimmunogenic substance, activates cellular processes such as migration, proliferation, and gene expression. A larger sample size than previous studies will be used, with treatment indicated when the bone crest-to-contact point distance exceeds 5 mm, as recommended by Norland and Tarnow 1998. All participants will receive full-mouth scaling and polishing one week before treatment to ensure tissue healing and reduce inflammation. Local anesthesia will be applied at the mucogingival junction before hyaluronic acid  injection to avoid interference with hyaluronic acid and reduce tissue punctures. A second hyaluronic acid injection will be administered after three weeks to reinforce the initial effect, based on manufacturer guidelines and previous studies. A follow-up evaluation will be conducted three months after the initial injection.

 
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