| CTRI Number |
CTRI/2025/09/094021 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Other (Specify) [Laser therapy ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of Laser assisted Ablative Versus Non-ablative Gingival Depigmentation: A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparative Evaluation of Laser assisted Ablative Versus Non-ablative Gingival Depigmentation : A Rabdomized 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 |
Shruti Singh |
| Designation |
JR 3 |
| Affiliation |
Saraswati Dental College and Hospital |
| Address |
233 A Saraswati Dental College
Lucknow
UTTAR PRADESH
-227105
India |
| Phone |
8707698 |
| Fax |
|
| Email |
shrutisingh22624@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Singh |
| Designation |
Post Graduate Student |
| Affiliation |
Saraswati Hospital & Research Centre |
| Address |
233 A Saraswati Dental College
604 B block, Shiva Apartment, Moti vihar Society, rawatpur crossing sarvodaya nagar, kanpur
Lucknow
UTTAR PRADESH
-227105
India |
| Phone |
8707698 |
| Fax |
|
| Email |
shrutisingh22624@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Singh |
| Designation |
JR 3 |
| Affiliation |
Saraswati Dental College and Hospital |
| Address |
233 A Saraswati Dental College
UTTAR PRADESH
-227105
India |
| Phone |
8707698 |
| Fax |
|
| Email |
shrutisingh22624@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saraswati Dental College & Hospital, Lucknow |
|
|
Primary Sponsor
|
| Name |
Saraswati Dental College & Research Centre |
| Address |
233 Faizabad road saraswati Dental College & Hospital Lucknow 227105 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Shruti singh |
233-A Faizabad road, Saraswati Dental College & Hospital, Lucknow |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shruti Singh |
Saraswati Dental College and Hospital |
Ayodhya Road Department of Periodontology
Room Number: 04
Lucknow
UTTAR PRADESH |
08707698123
shrutisingh22624@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
No systemic disease or condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laser assisted Ablative Gingival Depigmentation Procedure |
Laser assisted Ablative Gingival Depigmentation Procedure employed the use of 940 nm wavelength, power of 0.9 watt, in continuous wave mode with laser tip in contact with the tissue surface |
| Intervention |
Laser assisted Non-Ablative Gingival Depigmentation Procedure |
Laser assisted Non-Ablative Gingival Depigmentation Procedure employed the use of 445 nm wavelength, power of 0.9 watt, in continuous wave mode with laser tip in non-contact mode |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
18 to 35 years of age |
|
| ExclusionCriteria |
| Details |
1.The gingival hyperpigmentation that is secondary as a result of a systemic/ congenital condition/ disorder e.g. McCune Albright syndrome, Hutchinson Gilford Progeria Syndrome, Dyskeratosis congentia, Familial Progressive hyperpigmentation etc.
2. Participants with gingival hyperpigmentation due to the use of medications e. g. tetracycline.
3. Participants who were chronic smokers (self-reported)
4. Participants contraindicated for laser therapy (with phototoxicity, oral malignancy)
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinician reported outcomes (Dummet-Gupta oral pigmentation Index, Melanin Index, Gingival Pigmentation Index |
Baseline, 1 week, 1 month and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Patient Post Surgical Discomfort Score, Patient Satisfaction Score, Patient Esthetic Score |
Baseline, 1 week, 1 month and 3 month |
| Patient Post Surgical Discomfort Score (PPSDS), Patient Esthetic Score (PES), Patient Satisfaction Score (PSS) |
PPSDS- 24 hours after intervention
PES- Baseline, 1 week, 1 month and 3 months
PSS- 1 week, 1 month, 3 months. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/09/2025 |
| 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
|
The present split-mouth, prospective, single-centered, parallel group, non-placebo control, double- blinded (investigator and observer) simple randomized comparative clinical trial was conducted in the Department of Periodontology, Saraswati Dental College and Hospital, Lucknow, between April 2023 to December 2024. The study design and protocol were conducted in accordance with ethical principles laid down in Helsinki declaration 1998 revised 2013. After approval from Institutional Research and Development Committee (SDC/IRDC/2022/MDS/13) and Institutional Human Ethical Committee (SDC&H/IHEC/2022/MDS/13), all the participants were informed about the study and written informed consent were obtained from the patients in patient’s vernacular language. |