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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 
Details   
 
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.

 
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