| CTRI Number |
CTRI/2025/04/084025 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficiency in reducing gum pigmentation using microneedling and blade with and without Vitamin C |
|
Scientific Title of Study
|
Revolutionizing Gingival Depigmentation: Unveiling the Efficacy of Microneedling and Scalpel Technique with and without Topical Vitamin C – A Split-Mouth Clinical Trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ACDS/IEC/107/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAI PRIYA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Army College Of Dental Sciences |
| Address |
Room no 10, Department of Periodontics, PG clinic, Army College Of Dental Sciences Secunderabad Gabbilalpet Main Road Rajiv Swagruha ABHIMAAN Project
Chennapur -CRPF road
Army College Of Dental Sciences Secunderabad Gabbilalpet Main Road Rajiv Swagruha ABHIMAAN Project
Chennapur -CRPF road
Hyderabad
TELANGANA
500087
India |
| Phone |
09959964390 |
| Fax |
|
| Email |
saipriya.ck@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr, Sanjay Vasudevan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Army College Of Dental Sciences |
| Address |
Room no 10, Department of Peridontics, Army College Of Dental Sciences Secunderabad Gabbilalpet Main Road Rajiv Swagruha ABHIMAAN Project
Chennapur -CRPF road
Army College Of Dental Sciences Secunderabad Gabbilalpet Main Road Rajiv Swagruha ABHIMAAN Project
Chennapur -CRPF road
TELANGANA
500087
India |
| Phone |
9849062087 |
| Fax |
|
| Email |
drsanjayvasudevan2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
SAI PRIYA |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
Army College Of Dental Sciences |
| Address |
Room no 10, Department of Periodontics, PG clinic, Army College Of Dental Sciences Secunderabad Gabbilalpet Main Road Rajiv Swagruha ABHIMAAN Project
Chennapur -CRPF road
Army College Of Dental Sciences Secunderabad Gabbilalpet Main Road Rajiv Swagruha ABHIMAAN Project
Chennapur -CRPF road
TELANGANA
500083
India |
| Phone |
09959964390 |
| Fax |
|
| Email |
saipriya.ck@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SAI PRIYA |
| Address |
Army College Of Dental Sciences Secunderabad Gabbilalpet Main Road Rajiv Swagruha ABHIMAAN Project
Chennapur -CRPF road |
| 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 SAI PRIYA |
Army College of Dental Sciences |
Room no 10, Department of Periodontics, Pg Clinic
Hyderabad
TELANGANA |
09959964390
saipriya.ck@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ACDS Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hyperpigmentation of gums |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Depigmentation using dermapen device |
Depigmentation using dermapen device followed by topical application of vitamin c in 1st Quadrant.
Depigmentation using dermapen device only in 4th quadrant
|
| Comparator Agent |
Depigmentation using scalpel |
Depigmentation using scalpel followed by topical application of vitamin c in 2nd Quadrant.
Depigmentation using scalpel only in 3rd quadrant
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
With anterior melanin pigmentation ranging from mild to severe based on Dummets oral pigmentation index |
|
| ExclusionCriteria |
| Details |
Fully edentulous individuals. Pregnant and lactating women. Smokers, Patients who are under medications which affect the gingival color. Patients having any systemic condition that might induce or affect the melanin pigmentation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of pigmentation - can be accessed using Dummett oral pigmentation index and Hedin melanin index |
At baseline, 1 week, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Patient pain and wound itching scores by Visual analogue scale (VAS) and Verbal scale for wound itching respectively
|
after 7 days |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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)
|
10/04/2025 |
| 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 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
|
This study aims to compare the effects of four different treatment modalities for gingival pigmentation, using a split-mouth design where each patient’s four quadrants are assigned to distinct treatment groups: - Group A: Microneedling with Vitamin C
- Group B: Scalpel with Vitamin C
- Group C: Scalpel alone
- Group D: Microneedling alone
Patients are advised to avoid acidic or hot beverages for 24 hours post-treatment.
24 Hours Post-Treatment: Visual Analog Scale (VAS) for pain and verbal scale for wound itching are recorded.1 Week: Periodontal dressing is removed, and DOPI and HMI are re-recorded.1 Month & 3 Months: Follow-up visits are scheduled to assess and record DOPI and HMI scores. |