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CTRI Number  CTRI/2025/11/097016 [Registered on: 07/11/2025] Trial Registered Prospectively
Last Modified On: 07/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to determine the effect of medicated gel in patients with enlarged gums treated using laser light gums treatment or gum surgery to enhance the healing  
Scientific Title of Study   Comparative evaluation of Hyaluronic acid gel and photobiomodulation therapy on healing after surgical and laser gingivectomy 
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 Atluri Himasri 
Designation  III BDS Student 
Affiliation  Vishnu Dental College 
Address  Room no:7, Block -2, Department of Periodontics, Vishnu Dental College Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9959151696  
Fax    
Email  himasri.atluri@vdc.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Anil kumar K 
Designation  Associate Professor 
Affiliation  Vishnu Dental College 
Address  Room no:7, Block -2, Department of Periodontics, Vishnu Dental College Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9677209549  
Fax    
Email  dranilkumar1979@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Anil kumar K 
Designation  Associate Professor 
Affiliation  Vishnu Dental College 
Address  Room no:7, Block -2, Department of Periodontics, Vishnu Dental College Bhimavaram

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9677209549  
Fax    
Email  dranilkumar1979@gmail.com  
 
Source of Monetary or Material Support  
Vishnu Dental College, Vishnupur, Bhimavaram-534202, West Godavari District, Andhra Pradesh, India 
 
Primary Sponsor  
Name  Dr Atluri Himasri 
Address  III BDS, Room no:7, Block: 2, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram-354202, West Godavari District, Andhra Pradesh, 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 Atluri Himasri  Vishnu Dental College  Room no:7, Block -2, Department of Periodontics, Vishnu Dental College, Vishnupur, Bhimavaram-534202, Andhra Pradesh, India
West Godavari
ANDHRA PRADESH 
9959151696

himasri.atluri@vdc.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Vishnu Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  1. presence of inflammatory gingival overgrowth requiring gingivectomy in anterior esthetic zone. 2. Healthy individuals 18-35 years. 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Laser gingivectomy  Laser gingivectomy will be done with 810nm diode laser, 1.5 to 2W power, 300 microns fiber tip for complete removal of gingival overgrowth followed by photobiomodulation (PBM) with 200mW for 60sec immediately after surgery, 3rd, 7th, and 14th day. After PBM, gingelly gel topical application will be done on 3rd, 7th and 14th days. 
Comparator Agent  Surgical gingivectomy  Surgical gingivectomy with complete removal of gingival overgrowth followed by photobiomodulation (PBM) with 200mW for 60sec immediately after surgery, 3rd, 7th, and 14th day. After PBM, gingelly gel topical application will be done on 3rd, 7th and 14th days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. Systemically healthy individuals aged between 18 to 45 years
2. Presence of inflammatory gingival overgrowth requiring gingivectomy in anterior esthetic zone
Good oral hygiene  
 
ExclusionCriteria 
Details  1. Smokers, preganant or lactating women
2. Systemic disease or medications affecting healing
3. History of periodontal therapy in the past 6 months 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Wound healing will be assessed using the LANDRY index   3, 7, 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment and compare postoperative pain using VAS score associated with both adjunctive treatments.
 
1, 3, 7 days 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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)   18/11/2025 
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="6"
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 - NO
Brief Summary  

Gingivectomy is a common periodontal surgical procedure used to remove excess gingival tissue and improve esthetics or access for restorative therapy. Traditionally performed using a scalpel (surgical gingivectomy), laser-assisted techniques have gained popularity due to their minimally invasive nature, better hemostasis, and reduced postoperative discomfort.

Wound healing following gingivectomy plays a critical role in patient recovery, influencing both functional outcomes and esthetic satisfaction. To enhance healing, various adjunctive therapies have been explored. Among them, hyaluronic acid (HA) gel, known for its anti-inflammatory, bacteriostatic, and tissue-regenerative properties, has shown promise. Additionally, photobiomodulation therapy (PBMT) — the use of low-level laser/light therapy — has been reported to accelerate wound healing, reduce pain, and modulate inflammation through cellular photostimulation.

Despite promising individual results, few clinical trials have directly compared the efficacy of HA gel and PBMT following both surgical and laser gingivectomy procedures. This study aims to fill this gap by evaluating and comparing the healing outcomes associated with these two adjunctive therapies across both surgical techniques.

Primary Objective:

To compare the efficacy of hyaluronic acid gel and photobiomodulation therapy in enhancing wound healing following surgical and laser gingivectomy.

Secondary Objectives:

• To assess and compare postoperative pain and inflammation associated with both adjunctive treatments.
• To evaluate the time required for complete epithelial healing post-gingivectomy.

 
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