| CTRI Number |
CTRI/2025/07/091201 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
03/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to see which method works better to lighten dark gums |
|
Scientific Title of Study
|
Evaluation of Mesotherapy and Diode Laser for Gingival Depigmentation: An Ambispective Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nirav Vyas |
| Designation |
Resident Doctor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
3rd Floor, Centre for Dental Education and Research, All India Institute of Medical Sciences, New Delhi, India
South West
DELHI
110029
India |
| Phone |
9409609302 |
| Fax |
|
| Email |
niravvyas@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita Chawla |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no 309 Department of Conservative Dentistry and
Endodontics 3rd floor Center for Dental Education and research
AIIMS - New Delhi
South West
DELHI
110029
India |
| Phone |
9871445522 |
| Fax |
|
| Email |
dr.amritachawla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrita Chawla |
| Designation |
Additional Professor |
| Affiliation |
All India Institute Of Medical Sciences,New Delhi |
| Address |
Room no 309 Department of Conservative Dentistry and
Endodontics 3rd floor Center for Dental Education and research
AIIMS - New Delhi
South West
DELHI
110029
India |
| Phone |
9871445522 |
| Fax |
|
| Email |
dr.amritachawla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics Center for Dental Education and
research All India Institute of Medical Sciences New Delhi - 110029 |
|
|
Primary Sponsor
|
| Name |
Center for Dental Education and Research |
| Address |
Department of Conservative Dentistry and Endodontics Center for
Dental Education and research All India Institute of Medical Sciences
New Delhi - 110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nirav Vyas |
All India Institute of Medical Sciences |
3rd floor, Department of Conservative Dentistry and Endodontics,
Centre for Dental Education and Research,
All India Institute of Medical Sciences (AIIMS),
New Delhi – 110029,
India
South West
DELHI |
9409609302
niravvyas@aiims.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physiological Gingival Hyperpigmentataion |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gingival depigmentation with mesotherapy |
Injection of Vitamin C (1000 mg), glutahione (1000 mg) and tranexamic acid (4mg/ml) into the pigmented gingival areas using an insulin syringe. The agent is administered intramucosally once per week for 3 weeks. Each session lasts approximately 15–20 minutes. |
| Comparator Agent |
Laser Depigmentation |
Application of diode laser (wavelength 810 nm, power 1.5 W, continuous mode) to the pigmented gingival areas under local anesthesia. The laser is used to peel off the superficial pigmented layers in a single session. The procedure takes approximately 15–20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either gender between the age range of 20-40 years
2. Physiological gingival pigmentation in anterior maxillary and mandibular region
3. DOPI score between 1-3
4. ASA grade 1 individuals |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in gingival pigmentation, measured using the Dummett Oral Pigmentation Index (DOPI)
Absence of repigmentation, assessed through clinical examination |
Absence of re-pigmentation at 3-month follow-up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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 Yet Recruiting |
| 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
|
Non-surgical approaches as well as surgical intervention have been proposed for the management of melanin pigmentation. The surgical approaches depend mainly on the de-epithelization of the target region. It could be performed utilizing various techniques as free gingival grafts, gingivectomy or de-epithelialization using bur abrasion, surgical blade, laser and cryosurgery. Laser especially diode laser was the most frequently used technique and showed better esthetic outcomes, less pain, faster healing and most important patients’ preference and satisfaction after treatment. However, lasers were associated with more recurrence at 6-month follow-up. Therefore, there is a need to other minimally invasive non-surgical therapeutic option in order to depigment such conditions. |