| 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
|
|
|
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
|
|
|
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. |