| CTRI Number |
CTRI/2026/03/105350 [Registered on: 05/03/2026] Trial Registered Prospectively |
| Last Modified On: |
04/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand whether use of vitamin C is better than laser light for treatment of dark colour of gums in human. |
|
Scientific Title of Study
|
Comparative evaluation of gingival depigmentation using diode laser and microneedling with Vitamin C mesotherapy: A randomized 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 |
JUBY R P |
| Designation |
UG student- BDS |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
PMS College of Dental Science and Research,Golden Hill ,Venkode, Vattappara,Thiruvananthapuram 695028
Thiruvananthapuram KERALA 695028 India |
| Phone |
09074135440 |
| Fax |
|
| Email |
rpjuby@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DrAnanthalekshmi S S |
| Designation |
Reader |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Department of Periodontics, PMS College of Dental Science and Research,Golden Hill, Venkode, Vattappara,Thiruvananthapuram. 695028
Thiruvananthapuram KERALA 695028 India |
| Phone |
09497567049 |
| Fax |
|
| Email |
dr.lekshmianantha@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
DrAnanthalekshmi S S |
| Designation |
Reader |
| Affiliation |
PMS College of Dental Science and Research |
| Address |
Department of Periodontics, PMS College of Dental Science and Research, Golden Hill, Venkode, Vattappara,Thiruvananthapuram 695028
Thiruvananthapuram KERALA 695028 India |
| Phone |
09497567029 |
| Fax |
|
| Email |
dr.lekshmianantha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
KUHS UG Research Fellowship |
| Address |
KUHS, Kerala University of Health Sciences,
Medical College PO,Thrissur,Kerala 680596
Thrissur, Kerala, India
Pin 680 596 |
| Type of Sponsor |
Other [Study selected under UG research fellowship 2026] |
|
|
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 |
| DrAnanthalekshmi S S |
PMS college of dental science and research |
Department of Periodontics Thiruvananthapuram KERALA |
09497567049
dr.lekshmianantha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE PMS COLLEGE OF DENTAL SCIENCE AND RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy human volunteers who wants to under go depigmentation of gingiva |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diode laser for depigmentation of gingiva |
After applying local anaesthesia diode laser is used for depigmentation of gingiva.Review after 1 month,3 months and 6 months.
|
| Intervention |
vitamin C mesotherapy for depigmentation of gingiva |
Prior to the Microneedling procedure, topical local anesthesia spray will be administered. A Dermapen (Dr. Pen, Las Vegas, NV) device, and topical ascorbic acid powder (1,000 mg/mL) mixed with saline will be applied over the gingiva for 10 minutes.Four such appointments are given at an interval of 10 days.Review after 1 month,3 months and 6 months.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients with hyperpigmentation in the anterior gingiva. Patients are willing to get treated for gingival hyperpigmentation. Systemically healthy patients
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Diode laser over microneedling plus Vitamin C mesotherapy for gingival depigmentation |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
nil |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
16/03/2026 |
| 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="6" 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
|
A beautiful smiles is established by the harmonious relationship between the teeth and gingiva, i.e., the pink and white aesthetics. Gingival colour play a pivotal role in aesthetics, especially in patients with gummy smile. Gingival colour is governed by various factors such as, ethnicity, pregnancy, smoking, and drug intake.The gingival pigmentation is formed by melanoblasts, interlacing melanin granules between cells at the base of the gingival epithelium. The pigmentation degree differs depending on the melanoblastic interactions of each individual. Various validated procedures for gingival depigmentation (GD) include bur abrasion, scalpel scraping, cryotherapy, electrosurgery, and laser treatments.3 These methods are resective in nature ie entail the removal of the epithelial layer along with the underlying connective tissue to promote the regeneration of a new gingival epithelium devoid of melanin. More recently, non-resective methods such as non-ablative laser depigmentation, transepithelial depigmentation, and vitamin C–based mesotherapy have gained popularity. A study by Miao et al (2019) have shown that vitamin C inhibits tyrosinase activity in melanocytes by intracellular acidification. As tyrosinase is essential for the conversion of L-tyrosine to L dopa (a rate limiting step), its inhibition results in down regulation of melaninogenesis. Microneedling (MN) is a repetitive puncture technique recognized as a form of percutaneous collagen induction therapy. This process facilitates the penetration of topical medications across the stratum corneum layer. Diode laser ablation has been recognized as one of the most effective, comfortable and reliable techniques for gingival depigmentation. Objectives: To compare laser depigmentation using diode laser with microneedling technique in combination with vitamin C mesotherapy in the treatment of gingival pigmentation. |