| CTRI Number |
CTRI/2025/06/088632 [Registered on: 11/06/2025] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Microneedling technique versus Diode Laser for removal of pigmentation of gums |
|
Scientific Title of Study
|
Comparative evaluation of microneedling technique and diode laser in gingival depigmentation: A prospective randomized study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Natasha Singh |
| Designation |
Postgraduate student |
| Affiliation |
Manav Rachna International institute of Research and Studies |
| Address |
Room no 8, Third floor Department of Periodontology Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Suraj Kund Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9172166178 |
| Fax |
|
| Email |
angel.natasha1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Palwankar |
| Designation |
Professor and Head |
| Affiliation |
Manav Rachna Dental College SDS MRIIRS |
| Address |
Room no 8 Third floor Department of Periodontology Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Suraj Kund Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9891175112 |
| Fax |
|
| Email |
pooja.sds@mrei.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Natasha Singh |
| Designation |
Postgraduate student |
| Affiliation |
Manav Rachna Dental College SDS MRIIRS |
| Address |
Room no 8, Third floor Department of Periodontology Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Suraj Kund Badkhal Road
Faridabad
HARYANA
121004
India |
| Phone |
9172166178 |
| Fax |
|
| Email |
angel.natasha1998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Natasha Singh Postgraduate student
Department of periodontology Room no 8, Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Suraj Kund Badkhal Road Faridabad Haryana 121004 India |
|
|
Primary Sponsor
|
| Name |
Dr Natasha Singh Postgraduate student |
| Address |
Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Suraj Kund Badkhal Road Faridabad Haryana 121004 |
| 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 Natasha Singh |
Room 8 Department of Periodontology Manav Rachna Dental College SDS MRIIRS |
Room no 8 department of Periodontology Manav Rachna Dental College Sector 43 Delhi Suraj Kund Badkhal Road Faridabad 121004
Faridabad
HARYANA |
9172166178
angel.natasha1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manav Rachna Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
MELANIN PIGMENTATION |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Microneedling technique and Diode laser |
Once at baseline |
| Comparator Agent |
Microneedling technique versus Diode laser |
once at baseline |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Group 1 Microneedling
1 Periodontally healthy patient between 18 and 40 years
2 Patients with physiological melanin gingival pigmentation DOPI Index less than l
3 Patient with phenotype 2mm.
4Patient willing to maintain regular appointments and having good compliance
Group 2 Diode laser
1.Periodontally healthy patient between 18 and 40 years
2 Patients with physiological melanin gingival pigmentation DOPI Index less than 1
3 Patient with phenotype 2mm
4 Patient willing to maintain regular appointments and having good compliance |
|
| ExclusionCriteria |
| Details |
1 Systemically compromised patients or any medication that influence melanin pigmentation
2 Pregnant or lactating women
3 Smokers or tobacco chewers
4 Subjects undergone periodontal therapy in last 3 month
5. Subjects with Vitiligo |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Recurrence of pigmentation in
depigmentation when treated by
microneedling and diode laser. |
At 3 months, 6 months and 12 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| evaluation of pain using VAS scale |
24 hours and 7 days |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
25/06/2025 |
| 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="1"
Months="0"
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
|
Subjects with periodontally healthy status with physiological melanin gingival pigmentation (DOPI Index ≤ 1) with phenotype (2mm) will be selected and they undergo a depigmentation procedure either through microneedling or diode laser technique. The vas pain scale will be measured at 24 hours and 1 week. Recurrence of pigmentation will be assessed at 3, 6 ,12 months. in the subjects treated with Microneedling and Diode laser technique..
|