| CTRI Number |
CTRI/2025/06/088594 [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
|
A Study to Compare Two Natural Healing Methods Injectable Platelet rich fibrin and Platelet rich fibrin membrane Used with Laser Treatment to Improve Dark Gums |
|
Scientific Title of Study
|
Clinical evaluation of Injectable Platelet rich fibrin and Platelet rich fibrin membrane in Laser assisted gingival depigmentation. - A Randomized Controlled 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 |
Riddhika kochar |
| Designation |
PG student |
| Affiliation |
Km shah dental college , sumandeep vidyapeeth university Vadodra |
| Address |
Room no- 7, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Room no- 7, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Vadodara
GUJARAT
391760
India |
| Phone |
08975953131 |
| Fax |
|
| Email |
riddhikakochar23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor in Department of Periodontology |
| Affiliation |
Km shah dental college , sumandeep vidyapeeth university Vadodra |
| Address |
Room no- 7, Department of periodontology, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Riddhika kochar |
| Designation |
Pg student |
| Affiliation |
Km shah dental college , sumandeep vidyapeeth university Vadodra |
| Address |
Room no- 7, Department of periodontology, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Vadodara
GUJARAT
391760
India |
| Phone |
08975953131 |
| Fax |
|
| Email |
riddhikakochar23@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM shah dental college and hospital, vadodara
state-Gujrat
country- India |
|
|
Primary Sponsor
|
| Name |
Riddhika kochar |
| Address |
Girdhar vastra bhandar, bazar chowk nachangaon, plot no 5 (pulgaon)
District- wardha, pincode- 442306 |
| 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 |
| DrRiddhika kochar |
KM Shah Dental College, Sumandeep Vidyapeeth University Vadodara |
Room no- 7, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Vadodara
GUJARAT |
08975953131
riddhikakochar23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable Platelet-Rich Fibrin |
Injectable platelet-rich fibrin (i-PRF) contains high levels of growth factors, leukocytes, and platelets, resulting in a gradual and prolonged release into the tissues.Therefore promoting vascularization, triggering the expression of collagen-1 mRNA, and altering growth factor |
| Comparator Agent |
Platelet-Rich Fibrin (PRF) membrane |
a second generation platelet concentrate first developed by Choukroun et al. as a membrane nonetheless could provide its innate wound healing properties and thus aid in faster epithelization |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1.Male and female with age range from 16 to 45 years old.
2.Systemically healthy patients.
3.Gingival hyperpigmentation on maxillary and mandibular labial keratinized gingiva score 3 (Dummett et al., 1964) |
|
| ExclusionCriteria |
| Details |
1.Pregnant and lactating women.
2.Gingival pigmentation associated with occupational hazards.
3.Patients with missing anterior teeth.
4.Patients with any metallic restoration related to anterior teeth or undergoing orthodontic treatment.
5.Smokers patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Healing index |
at 7th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Dummett-Gupta Oral Pigmentation Index (DOPI) |
baseline, 1 week and 1 month |
| Gingival biotype |
at baseline and after 1 month |
| Visual Analog Scale (VAS) |
at 3rd day and 7th day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
24/06/2025 |
| 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="0"
Months="6"
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
|
This study compares two types of platelet concentrates—Injectable Platelet-Rich Fibrin (i-PRF) and Platelet-Rich Fibrin (PRF) membrane—in patients undergoing laser-assisted gingival depigmentation. The aim is to evaluate and compare their effects on wound healing, patient comfort, and tissue regeneration following the procedure. Both biomaterials are derived from the patient’s own blood but differ in their consistency and application method. This comparative analysis will help determine which form of PRF provides better clinical outcomes in terms of healing and aesthetic improvement. |