| CTRI Number |
CTRI/2026/03/105695 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Study of Gingival Depigmentation Using Injectable Glutathione, Vitamin C and Tranexamic Acid with and without Low-Level Laser Therapy |
|
Scientific Title of Study
|
Comparative Study of Gingival Depigmentation Using Injectable Glutathione, Vitamin C and Tranexamic Acid with and without Low-Level Laser Therapy: Randomized Controlled Clinical Trial |
| 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 MANALI SHASHIKANT WAGHMARE |
| Designation |
POST GRADUATE |
| Affiliation |
VYWS dental college and hospital |
| Address |
department of periodontology, room no. 16, VYWS dental college and hospital
tapovan- wadali road, srpf colony, amravati, maharashtra- 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
8369973910 |
| Fax |
|
| Email |
manaliwaghmare976@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SIMRAN R. PARWANI |
| Designation |
PROFESSOR AND HEAD OF THE DEPARTMENT |
| Affiliation |
VYWS dental college and hospital |
| Address |
department of periodontology, room no. 16, VYWS DENTAL COLLEGE AND HOSPITAL, AMRAVATI-444602
tapovan- wadali road, srpf colony, amravati, maharashtra- 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
9977132697 |
| Fax |
|
| Email |
simpar74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MANALI SHASHIKANT WAGHMARE |
| Designation |
POST GRADUATE |
| Affiliation |
VYWS dental college and hospital |
| Address |
department of periodontology, room no. 16, VYWS dental college and hospital
tapovan- wadali road, srpf colony, amravati, maharashtra- 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
8369973910 |
| Fax |
|
| Email |
manaliwaghmare976@gmail.com |
|
|
Source of Monetary or Material Support
|
| VYWS Dental College and Hospital, department of periodontology, tapovan-wadali road, amravati-444602 |
|
|
Primary Sponsor
|
| Name |
Dr Manali S Waghmare |
| Address |
VYWS Dental College and Hospital, department of periodontology, tapovan-wadali road, SRPF colony, amravati-444602 |
| Type of Sponsor |
Other [SELF SPONSERED] |
|
|
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 MANALI S WAGHMARE |
VYWS Dental college and Hospital |
Tapovan - Wadali road SRPF Colony, amravati-444602
Amravati
MAHARASHTRA |
8369973910
manaliwaghmare976@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VYWSDCHA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
gingival depigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group A |
1. Written informed consent will be obtained
2. Clinical evaluation and baseline pigmentation scoring will be done using Dummet’s Gingival Pigmentation Index.
3. Preparation of injectable solution (600mg Glutathione + 500mg Vit. C + 500mg Tranexamic acid) under aseptic conditions.
4. Extraoral scrubbing will be done.
5. Local infiltration anesthesia will be given in the selected maxillary and mandibular sextants.
6. Injectable solution (600mg Glutathione + 500mg Vit. C + 500mg Tranexamic acid into pigmented gingiva in both control and test group; thrice for three weeks consecutively.
7. Postoperative instructions will be given
8. Follow-up at one, three and six months will be done. |
| Intervention |
test group B |
1. Written informed consent will be obtained
2. Clinical evaluation and baseline pigmentation scoring will be done using Dummet’s Gingival Pigmentation Index.
3. Preparation of injectable solution (600mg Glutathione + 500mg Vit. C + 500mg Tranexamic acid) under aseptic conditions.
4. Extraoral scrubbing will be done.
5. Local infiltration anesthesia will be given in the selected maxillary and mandibular sextants.
6. In Group B, LLLT will be applied with diode laser post-injection for 20-60 seconds in continuous wave motion at 3.5 W power and 980nm wavelength in the region of gingival pigmentation.21
7. Postoperative instructions will be given
8. Follow-up at one, three and six months will be done.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
INCLUSION CRITERIA
1) Systemically healthy patients
2) Presence of gingival hyperpigmentation in maxillary and/ or mandibular sextants
3) Age 18–40 years
4) High esthetic concern
|
|
| ExclusionCriteria |
| Details |
EXCLUSION CRITERIA
1) Smokers
2) Pregnant or lactating women
3) Patients with systemic diseases affecting pigmentation
4) History of previous depigmentation treatment
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Dummet’s Gupta Gingival Pigmentation Index (1945)
|
BASELINE, one month, three months and six months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| healing index , VAS pain score |
baseline , one month, three months and six months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 2 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 is a comparative evaluation of injectable glutathione, vitamin C and tranexamic acid in gingival depigmentation with and without low level laser therapy- a randomized controlled clinical trial. parameters evaluated are dummet gupta oral pigmentation index, plaque ad gingival index, healing index. vitamin C is a potent antioxidant, tranexamic acid inhibits plasmin activity , glutathione converts eumelanin to pheomelanin and low level laser theray aids in healing , fibroblast proliferation and prevetns inflammation. however there is paucity of literature comparing the use of injectable lutathione, vitamin C and tranexamic acid with and without low level laser therpay in gingival depigmenation. therefore, our study aims at comparing the use of injectable glutahione, vitamin C and tranexamic acid with and without low level laser therapy in gingival depigmentation. |