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CTRI Number  CTRI/2026/04/108395 [Registered on: 15/04/2026] Trial Registered Prospectively
Last Modified On: 15/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to compare different methods for reducing black gums 
Scientific Title of Study   Efficacy of microneedling with hyaluronic acid and low level laser therapy in gingival depigmentation- 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  Dr Pragya Goel 
Designation  Post graduate Student 
Affiliation  Manav Rachna Dental College SDS MRIIRS 
Address  Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund Road Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  9880196589  
Fax    
Email  pragya.318@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nipun Dhalla 
Designation  Professor 
Affiliation  Manav Rachna Dental College SDS MRIIRS 
Address  Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund Road Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  9811052296  
Fax    
Email  nipundhalla.sds@mrei.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Nipun Dhalla 
Designation  Professor 
Affiliation  Manav Rachna Dental College SDS MRIIRS 
Address  Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund Road Faridabad Haryana

Faridabad
HARYANA
121004
India 
Phone  9811052296  
Fax    
Email  nipundhalla.sds@mrei.ac.in  
 
Source of Monetary or Material Support  
Dr Pragya Goel Postgraduate Student Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana 
 
Primary Sponsor  
Name  Dr Pragya Goel 
Address  Postgraduate Student Department of Periodontology Room No QT 25 26 Manav Rachna Dental College SDS MRIIRS Sector 43 Delhi Surajkund road Faridabad Haryana 
Type of Sponsor  Other [(self)] 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pragya Goel  Manav Rachna Dental College SDS MRIIRS  Department of Periodontology Room No QT 25 26 Sector 43 Delhi surajkund road Faridabad
Faridabad
HARYANA 		 9880196589

pragya.318@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Manav Rachna Dental College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically healthy patients  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low Level Laser Therapy, Microneedling and Hyaluronic acid Gel  Low level laser therapy will be done after microneedling and hyaluronic acid gel application. Clinical assessment will be performed using DOPI index at baseline,3 months and 6 months. Landrys healing index is to be taken at 1 week and 1 month and PIGAQ index at baseline and 3 months. Total duration of the study will be 6 months.  
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Systemically healthy patients
2.Presence of gingival melanin pigmentation in maxillary and mandibular region within the aesthetic zone
3.Patients willing to maintain regular appointments and having good compliance
 
 
ExclusionCriteria 
Details  1.Patients with poor oral hygiene and periodontal disease.
2.Uncontrolled systemic diseases affecting wound healing and blood dyscrasias
3.Pregnant and lactating females
4.Tobacco in all forms
5.Patients with hypersensitivity to Photo biomodulation (PBM) or Hyaluronic Acid (HA) gel
6.Patients with a history of use of medications known to induce oral pigmentation
7.Patients undergone periodontal therapy in last 3 months
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Recurrence of pigmentation in depigmentation when treated by microneedling and diode laser  At baseline, 3 months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate improvement and rate of repigmentation in gingiva post depigmentation.  At baseline, 3 months and 6 months 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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)   09/06/2026 
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="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  

Randomized clinical study aims to compare the efficacy of different treatment modalities for gingival depigmentation. Patients will be randomly allocated into three groups. The control group will receive diode laser treatment followed by low level laser therapy. The first test group will undergo microneedling followed by low level laser therapy. The second test group will receive microneedling with topical hyaluronic acid followed by low level laser therapy. All patients will undergo scaling and root planing prior to intervention. Clinical outcomes will be assessed using depigmentation index PIGAQ and healing index. The study aims to identify an effective and minimally invasive approach for gingival depigmentation.


 
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