| CTRI Number |
CTRI/2025/01/079128 [Registered on: 21/01/2025] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A Comparative study of using vitamin-c vs
conventional surgical technique in gingival depigmentation |
|
Scientific Title of Study
|
A Comparative evaluation of using vitamin-c by mesotherapy technique vs conventional surgical technique using scalpel in gingival depigmentation of physiologically hyperpigmented gingiva
|
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| FDS/DDU/EC/07/2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jinal Parmar |
| Designation |
Resident Docter |
| Affiliation |
Dharamsinh Desai University |
| Address |
Dharamsinh Desai University, Faculty Of Dental Science, Collage Road, Nadiad-387001, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
7016292613 |
| Fax |
|
| Email |
Khushbuparmar787@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vasumati Patel |
| Designation |
Head of the Department |
| Affiliation |
Dharamsinh Desai University |
| Address |
Dharamsinh Desai University, Faculty Of Dental Science, Collage Road, Nadiad-387001, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
8200210769 |
| Fax |
|
| Email |
pateldrvasu@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jinal Parmar |
| Designation |
Resident Docter |
| Affiliation |
Dharamsinh Desai University |
| Address |
Dharamsinh Desai University, Faculty Of Dental Science, Collage Road, Nadiad-387001, Gujarat
Kheda
GUJARAT
387001
India |
| Phone |
07016292613 |
| Fax |
|
| Email |
Khushbuparmar787@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dharamsinh Desai University, Faculty Of Dental Science,
Nadiad, Gujarat, India 387001 |
|
|
Primary Sponsor
|
| Name |
Dharamsinh desai University |
| Address |
Dharamsinh Desai University, Faculty Of Dental Science, Collage Road, Nadiad-387001, Gujarat |
| Type of Sponsor |
Research institution |
|
|
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 Jinal Parmar |
Dharamsinh Desai University |
Department of periodontology,
Faculty of dental science,
Dharamsinh Desai University, Collage Road, Nadiad-387001, Gujarat
Kheda
GUJARAT |
7016292613
Khushbuparmar787@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of Faculty of Dental Science Dharmsinh Desai University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Physiologic gingival hyperpigmentation related to aesthetic reion,
Patient exhibiting good oral hygiene |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Surgical technique |
Partial thickness incision involved the entire
hyperpigmented area on the keratinised gingival surface,
with the blade placed parallel to the long axis of the teeth |
| Intervention |
Vitamin C |
Vitamin c by insulin syringe 0.1ml at 2-3mm apart introduced into the respective gingival
tissues with the bevel facing in the upward direction. Tis
dose of Vitamin C was continued for four weeks, once per
week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Physiologic gingival hyperpigmentation related to aesthetic region are selected
Patients exhibiting good oral hygiene
|
|
| ExclusionCriteria |
| Details |
Any systemic disease associated with pathological hyperpigmentation or
improper delayed wound healing (uncontrolled diabetes, autoimmune diseases,
etc.)
Pregnant and lactating women
Smokers, tobacco users |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival Depigmentation by using vitamin c and conventional surgical technique |
AT 1,3,6months of follow up time period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
less reduction
in intensity of melanin pigmentation with the test group
compared to the control group |
1,3,6 months of follow up time period |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "24"
Final Enrollment numbers achieved (India)="24" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
23/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
23/08/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Based on the present investigation evaluating the effectiveness of vitamin c and the conventional surgical technique in gingival depigmentation following conclusions can be drawn. Result of present study may show statistically comparable outcomes can be achieved with both techniques. less reduction in intensity of melanin pigmentation with the test group compared to the control group. |