| 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
|
|
|
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
|
|
|
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. |