| CTRI Number |
CTRI/2025/09/094917 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
16/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Local Spray( Vitamin C and Glutathione) Application and Laser for the treatment of Dark gums: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparative Analysis of Topical Glutathione and Ascorbic Acid vs. Laser Therapy for Gingival Depigmentation: A Randomized Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Donepudi Sripragna |
| Designation |
Post graduate |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Periodontology, room no. 5, Narayana Dental college and Hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9490690619 |
| Fax |
|
| Email |
sripragnadonepudi97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sreenivas Nagarakanti |
| Designation |
Professor and Head of the Department |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Periodontology, room no. 5, Narayana Dental college and Hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreenivas Nagarakanti |
| Designation |
Professor and Head of the Department |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Periodontology, room no. 5, Narayana Dental college and Hospital, Chinthareddypalem, Nellore
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Donepudi Sripragna Department of Periodontology, room no. 5, Narayana Dental college and Hospital, Chinthareddypalem, Nellore 524003 |
|
|
Primary Sponsor
|
| Name |
Donepudi Sripragna |
| Address |
Department of Periodontology, room no. 5, Narayana Dental college and Hospital, Chinthareddypalem, Nellore 524003 |
| 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 Donepudi Sripragna |
Narayana Dental College and Hospital |
Department of Periodontology, Room no. 5, Narayana Dental College and Hospital, Chinthareddypalem, Nellore 524003
Nellore
ANDHRA PRADESH |
9490690619
sripragnadonepudi97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee IEC,NDCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
physiologic melanin pigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Glutathione and Ascorbic acid spray |
A topical spray containing glutathione and ascorbic acid (ETHIGLO Spray, ETHICARE REMEDIES, Glutathione 50mg/ml, Vitamin C 20mg/ml). |
| Comparator Agent |
LASER depigmentation |
Hyperpigmented gingiva is depigmented using diode laser with a wavelength of 810–980 nm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals
Participants above 18 years
Participants with physiologic melanin pigmentation
Healthy gingival tissues without active Periodontal disease
Participants with aesthetic concern
|
|
| ExclusionCriteria |
| Details |
Pathological pigmentation of gingiva
Clinically evident gingivitis
Known allergic to glutathione and vitamin C
Using tobacco in any form
History of depigmentation procedures
Pregnant and lactating women
Systemic conditions and drugs affecting pigmentation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dummett oral pigmentation index(DOPI) Gingival pigmentation index(GPI) |
4, 12 and 24 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient satisfaction and acceptance questionnaire
Recurrence |
4,12 and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
04/12/2025 |
| 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="1"
Months="0"
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
|
Aim: To evaluate and compare efficacy of topical application of Glutathione combined with vitamin C versus laser therapy in the treatment of gingival depigmentation.
All the participants will be explained about the aim and procedure along with written informed consent for their participation before the commencement of study.
This study is a randomized clinical trial, conducted in healthy individuals with hyperpigmented gingiva, the study duration is 12months in which clinical parameters will be recorded at 4, 12 and 24 weeks.
This study will be performed in accordance with Helsinki declaration of 1975, as revised in 2013.
The clinical parameters assessed are: 1. Dummett oral pigmentation index 2. Gingival pigmentation index 3. Plaque index 4. Modified sulcular bleeding index
Initially, scaling will be done to ensure a plaque free operating site. After informing the procedure of depigmentation in detail, a written consent will be obtained from the patient. Before the procedure, the participants will be divided into Group A and Group B.
Group A: Laser Therapy Gingival depigmentation will be performed using a diode laser with a wavelength of 810–980 nm. The procedure will involve local anesthesia (Topical Spray-Lidocaine 15% w/w) followed by the laser ablation of the pigmented epithelium. A single session will be conducted, lasting approximately 15–30 minutes, depending on the extent of pigmentation. Postoperative care instructions will include avoiding spicy or hot foods and using an antiseptic mouthwash.
Group B: Topical Treatment (Glutathione + Ascorbic Acid) A topical spray containing glutathione and ascorbic acid (ETHIGLO Spray, ETHICARE REMEDIES, Glutathione 50mg/ml, Vitamin C 20mg/ml). The spray will be applied by a clinician for the first time to demonstrate how to be applied by the participant thereafter to the pigmented gingival areas twice a day for 4 weeks. Participants will be instructed to avoid rinsing, eating, drinking, or brushing their teeth for 30 minutes’ post-application.
Post operative instructions will be given to the patients and patients are asked to report back incase of any discomfort. All the participants will be recalled after 4, 12 and 24 weeks. |