| CTRI Number |
CTRI/2025/06/089146 [Registered on: 19/06/2025] Trial Registered Prospectively |
| Last Modified On: |
18/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Wound healing in gum surgery |
|
Scientific Title of Study
|
Comparative evaluation of clinical outcomes , wound healing and post operative pain response to gingival depigmentation techniques- A randomised 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 |
Swet Nisha |
| Designation |
Associate Professor |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Department Of Periodontology,Division -Dentistry Banbishnupur
Medinipur
WEST BENGAL
721645
India |
| Phone |
09883916227 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swet Nisha |
| Designation |
Associate Professor |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Department Of Periodontology,Division -Dentistry Banbishnupur
WEST BENGAL
721645
India |
| Phone |
09883916227 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Swet Nisha |
| Designation |
Associate Professor |
| Affiliation |
Haldia Institute Of Dental Sciences and Research |
| Address |
Department Of Periodontology,Division -Dentistry Banbishnupur
WEST BENGAL
721645
India |
| Phone |
09883916227 |
| Fax |
|
| Email |
swetnisha1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Haldia Institute Of Dental Sciences and Research,Department Of Periodontology,Division -Dentistry Banbishnupur
Medinipur
WEST BENGAL
721645
India |
|
|
Primary Sponsor
|
| Name |
Swet Nisha |
| Address |
Haldia Institute Of Dental Sciences and Research,Department Of Periodontology,Division -Dentistry Banbishnupur
Medinipur
WEST BENGAL
721645
India |
| 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 |
| DrSwet Nisha |
Haldia Institute Of Dental Sciences and Research |
Department Of Periodontology,Division -Dentistry Banbishnupur
Medinipur
WEST BENGAL |
09883916227
swetnisha1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Haldia Institute Of Dental Sciences and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Electrocautery |
Gingival depigmentation with electrocautery method will be performed. Wound healing index will be assessed. |
| Comparator Agent |
Scalpel gingival depigmentation technique |
gingival depigmentation will be performed using scalpel method and early wound healing index will be measured |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Participants with esthetic concern of gingiva.
smokers |
|
| ExclusionCriteria |
| Details |
participants having systemic diseases like hypertension, diabetes mellitus
pregnant and lactating mother |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate effect scapel and electrocautery method in gingival wound healing. |
1 week,1 month,3 month,6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 4 |
|
Date of First Enrollment (India)
|
30/06/2025 |
| 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
|
Gingival Depigmentation are procedures of esthetic concern. The aim of the present study is to evaluate the efficacy of gingival depigmentation surgical techniques in terms of wound healing and pain management, |