| CTRI Number |
CTRI/2025/07/091703 [Registered on: 25/07/2025] Trial Registered Prospectively |
| Last Modified On: |
24/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Healing of gums after LASER depigmentation HYALURONIC ACID vs OZONATED OIL |
|
Scientific Title of Study
|
COMPARING THE EFFICACY OF 0.2 PERCENT HYALURONIC ACID GEL AND OZONATED OIL IN WOUND HEALING AFTER LASER-ASSISTED DEPIGMENTATION |
| 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 Fathima suharal |
| Designation |
Post graduate student |
| Affiliation |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh
Srikakulam
ANDHRA PRADESH
532401
India |
| Phone |
9392346929 |
| Fax |
|
| Email |
fathimasuharal@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANIL KUMAR |
| Designation |
Professor and head of the department |
| Affiliation |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh
Srikakulam
ANDHRA PRADESH
532401
India |
| Phone |
9989570600 |
| Fax |
|
| Email |
anilkanc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Fathima suharal |
| Designation |
Post graduate student |
| Affiliation |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh
Srikakulam
ANDHRA PRADESH
532401
India |
| Phone |
9392346929 |
| Fax |
|
| Email |
fathimasuharal@yahoo.com |
|
|
Source of Monetary or Material Support
|
| SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh 532401 , India |
|
|
Primary Sponsor
|
| Name |
Dr Fathima suharal |
| Address |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh 532401,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 Fathima suharal |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE,
Department of periodontology,
Chapuram, Srikakulam, Andhra Pradesh 532401
Srikakulam
ANDHRA PRADESH |
9392346929
fathimasuharal@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients with gingival pigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
HYALURONIC ACID GEL |
Patients received laser-assisted depigmentation with 0.2 percent hyaluronic acid gel, followed by evaluations on days 3 and 7. |
| Comparator Agent |
OZONATED OIL |
Patients received laser-assisted depigmentation with ozonated oil, followed by evaluations on days 3 and 7. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients aged between 20-55 years.
2 Systemically healthy patients.
3 Patients who met Dummet Pigementation index of score 2 and 3.
|
|
| ExclusionCriteria |
| Details |
1 Patients on antibiotics or anti-inflammatory medicines.
2 History of periodontal surgery within the last 6 months.
3 Women who are pregnant and lactating mothers.
4 Patients with adverse habits.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| wound healing, visual analog scale. |
day 3 and 7. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pigmentation |
baseline and 3 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
04/08/2025 |
| 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="0"
Months="3"
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
|
The current randomized split-mouth study consists of 25 systematically healthy patients. Patients will be chosen according to specified inclusion and exclusion criteria. Informed consent will be acquired from each patient, and subsequently, they are randomly assigned to one of two groups. Group I patients will receive laser depigmentation with 0.2 percent hyaluronic acid gel and group 2 will receive laser assisted depigmentation with ozonated oil.Initially scaling and root planning will be done followed by oral hygiene instructions. patients will be re evaluated after 1 week for optimum oral hygiene.Depigmentation will be performed using diode laser(800nm, 1W) under topical anesthesia, required amount of 0.2 percent hyaluronic acid gel and ozonated oil will be applied at de-epithelized area followed by periodontal dressing placement.The patients were recalled on the 3rd day and the periodontal pack was removed. - Pain was assessed using VAS score on days 3 & 7 day.
- Healing was assessed using Landry, Turnbull, and Howley wound healing index on days 3 & 7day.
- Pigmentation was assessed using Dummett Oral Pigmentation Index (DOPI), at Baseline & after 3 months.
|