| CTRI Number |
CTRI/2026/03/105598 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Healing, Pain and Recurrence of Gum Pigmentation After Surgical, Diode Laser and Microneedling Depigmentation Methods |
|
Scientific Title of Study
|
A COMPARATIVE ANALYSIS OF HEALING, REPIGMENTATION AND PAIN DURING GINGIVAL DEPIGMENTATION USING CONVENTIONAL SURGICAL METHOD, DIODE LASER AND MICRONEEDLING – 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 |
Kena Gajjar |
| Designation |
Post Graduate student |
| Affiliation |
College of Dental Science and Hospital, Amargadh |
| Address |
Shivdhara appatment, nr. Takteshwar temple, Bhavnagar
College of Dental Science and hospital, K.J. Mehta T.B. trust, Amargadh, Sihor, Bhavnagar, Gujarat 364210
Bhavnagar
GUJARAT
364001
India |
| Phone |
7227895224 |
| Fax |
|
| Email |
kenig2209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashok KP |
| Designation |
PG guide and Head of the Department |
| Affiliation |
College of Dental Science and hospital |
| Address |
College of Dental Science and hospital, K.J. Mehta T.B. trust, Amargadh
Bhavnagar
GUJARAT
364210
India |
| Phone |
7049754198 |
| Fax |
|
| Email |
drashokkp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashok KP |
| Designation |
PG guide and Head of the Department |
| Affiliation |
College of Dental Science and hospital |
| Address |
College of Dental Science and hospital, K.J. Mehta T.B. trust, Amargadh
GUJARAT
364210
India |
| Phone |
7049754198 |
| Fax |
|
| Email |
drashokkp@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Science and hospital, amargadh, Bhavnagar 364210 |
|
|
Primary Sponsor
|
| Name |
College of Dental Science and hospital |
| Address |
College of Dental Science and hospital, K.J Mehta trust, Amrgadh, Sihor, Bhavnagar 364210 |
| Type of Sponsor |
Private medical college |
|
|
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 Kena Gajjar |
CODS Amargadh |
Department of
Periodontics division P
IX-Perio College of
dental science and
hospital, K.J mehta
trust, Amargadh, Sihor,
Bhavnagar,
GUJARAT 364210
Bhavnagar
GUJARAT |
72278 95224
kenig2209@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Bimaxillary melanin hyperpigmentation |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Surgical method |
• In group 1 participant, after achieving local anesthesia, 15 no. BP blade will be used for scraping the gingival epithelium and a layer of connective tissue. |
| Intervention |
Diode LASER |
• In group 2 participant, after achieving local anesthesia, pigmented gingiva will be ablated by Diode LASER at wavelength of 450nm at 2 watt power in a continuous wave mode with a flexible fiber optic delivery system taking all precautions to safeguard the patient. |
| Intervention |
Microneedling |
• In group 3 participant, after achieving local anesthesia, microneedling will be done using Dermapen. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
•15 - 40 years age group
•Both Male and Female
•Periodontally healthy subjects
•Bimaxillary melanin hyperpigmentation in the facial aspects of anterior regions with moderate or heavy clinical pigmentation according to Dummett and Gupta index.
|
|
| ExclusionCriteria |
| Details |
•Systemically compromised Patients
•Patient with smoking habit
•Patient using drugs with potential to cause oral pigmentation
•Pregnant and lactating women
•Subjects with thin gingival biotype
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2026 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
15-40 years aged patients reporting to the Department of Periodontology at the College of Dental Science and hospital, Amargadh with bimaxillary melanin hyperpigmentation in the facial aspects of anterior regions will be considered inclusion criteria for the study. A total of 45 patients will be selected for the study to evaluate and compare the healing, repigmentation and pain during gingival depigmentation using conventional surgical method using scalpel, Diode LASER and microneedling. This study will be done to evaluate whether microneedling can be considered a better alternative for depigmentation over Diode LASER and conventional scalpel method.
|