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CTRI Number  CTRI/2025/02/080441 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 31/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Biological
Medical Device
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A study on how to lighten dark spots on gums using microneedling with and without topically applied niacinamide, compared to the traditional scalpel method 
Scientific Title of Study   Gingival depigmentation using Microneedling technique with and without topical application of Niacinamide versus the conventional scalpel technique: A randomized controlled clinical trail 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sanjyoti Patil 
Designation  Post Graduate Resident 
Affiliation  Tatyasaheb Kore Dental College and Research Center, New Pargaon 
Address  Tatyasaheb Kore Dental College & Research Center, Vathar Kodoli Rd, Nave Pargaon, Maharashtra 416113

Kolhapur
MAHARASHTRA
416113
India 
Phone  8669525668  
Fax    
Email  sanjyotiworkmail@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhijeet Shete 
Designation  Head of Department of Periodontology 
Affiliation  Tatyasaheb Kore Dental College and Research Center, New Pargaon 
Address  Department of Periodontology Tatyasaheb Kore Dental College and Research Center, New Pargaon District- Kolhapur

Kolhapur
MAHARASHTRA
416113
India 
Phone  9325220496  
Fax    
Email  drabhijeetshete@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Abhijeet Shete 
Designation  Head of Department of Periodontology 
Affiliation  Tatyasaheb Kore Dental College and Research Center, New Pargaon 
Address  Department of Periodontology Tatyasaheb Kore Dental College and Research Center, New Pargaon District- Kolhapur

Kolhapur
MAHARASHTRA
416113
India 
Phone  9325220496  
Fax    
Email  drabhijeetshete@gmail.com  
 
Source of Monetary or Material Support  
Tatyasaheb Kore Dental College & Research Center, Vathar Kodoli Rd, Nave Pargaon, Maharashtra 416113 
 
Primary Sponsor  
Name  Sanjyoti Patil 
Address  Tatyasaheb Kore Dental College & Research Center, Vathar Kodoli Rd, Nave Pargaon, Maharashtra 416113 
Type of Sponsor  Other [Self] 
 
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 
Sanjyoti Patil  Tatyasaheb Kore Dental College & Research Center,New Pargaon  Department of Periodontology Tatyasaheb Kore Dental College & Research Center, Vathar Kodoli Rd, Nave Pargaon, Maharashtra 416113
Kolhapur
MAHARASHTRA 
8669525668

sanjyotiworkmail@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Tatyasaheb Kore Dental College & Research Center   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Use of the Conventional Scalpel Technique for reducing gingival pigmentation  To evaluate the effectiveness of the Microneedling (MN) technique with niacinamide, MN technique alone, and conventional scalpel technique of gingival depigmentation using Dummet Oral Pigmentation Index (DOPI) at baseline and after 2 weeks in hyperpigmented gingiva 
Intervention  Use of the Microneedling technique (MN) with topical application of niacinamide for reducing gingival pigmentation  To evaluate the effectiveness of the Microneedling (MN) technique with niacinamide, MN technique alone, and conventional scalpel technique of gingival depigmentation using Dummet Oral Pigmentation Index (DOPI) at baseline and after 2 weeks in hyperpigmented gingiva 
Intervention  Use of the Microneedling technique for reducing gingival pigmentation  To evaluate the effectiveness of the Microneedling (MN) technique with niacinamide, MN technique alone, and conventional scalpel technique of gingival depigmentation using Dummet Oral Pigmentation Index (DOPI) at baseline and after 2 weeks in hyperpigmented gingiva 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Individuals with physiologic melanin pigmentation on the anterior portion of the upper and lower gingiva.
Systemically healthy individuals.
Individuals of 16-45 years of age from both genders. 
 
ExclusionCriteria 
Details  Patients with habits of tobacco in any form, pan chewing etc.
Pregnant or lactating women.
Individuals with periodontal disease.
Patients who had previous depigmentation procedures done.
Patients who are allergic to niacinamide.
Patients on drugs that cause gingival pigmentation like antimalarial, oral contraceptives, ketoconazole etc.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The effect of using the MN technique along with and without topical application of niacinamide compared to the effect of conventional scalpel technique in reducing pigmentation in hyperpigmented gingiva.  4 months 
 
Secondary Outcome  
Outcome  TimePoints 
Whether microneedling technique with and
without topical niacinamide shows better post
operative healing as compared to conventional
scalpel technique.


 
4 months 
Whether microneedling technique with and
without topical niacinamide shows less post
operative pain as compared to conventional
scalpel technique. 
4 months 
 
Target Sample Size   Total Sample Size="15"
Sample Size from India="15" 
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 4 
Date of First Enrollment (India)   25/02/2025 
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="4"
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  
Gingival depigmentation is a periodontal plastic procedure aimed at the removal of melanocytic pigmentation, utilizing various methods such as surgical scraping and electrosurgery. Among these options, the microneedling (MN) technique has emerged as a minimally invasive approach that enhances collagen regeneration through the creation of micro-perforations in the tissue, facilitating improved penetration of topically applied therapeutic agents. 

Niacinamide, an amide derivative of vitamin B3, is recognized for its skin-lightening properties, particularly in the context of treating cutaneous pigmentation. Its mechanism of action involves the suppression of melanosome transfer from melanocytes to keratinocytes, thereby reducing pigmentation.

While numerous clinical investigations have evaluated the efficacy of the MN technique for pigmentation treatment and skin rejuvenation, there is a notable paucity of dental studies addressing its effects within the oral cavity. In light of this gap in the literature, the present study employs the MN technique for the treatment of gingival pigmentation in conjunction with the topical application of niacinamide as a depigmenting agent. This dual approach aims to assess the potential benefits of combining these methodologies in the context of oral pigmentation management.
 
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