| CTRI Number |
CTRI/2024/08/071969 [Registered on: 06/08/2024] Trial Registered Prospectively |
| Last Modified On: |
05/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Conventional gingivectomy vs LASER gingivectomy |
|
Scientific Title of Study
|
Comparison of conventional vs LASER gingivectomy in the management of gingival enlargement: A clinical 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 |
Logalakxmi J K |
| Designation |
Post graduate |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Room no : 7 , Department of Periodontics , Karpaga Vinayaga Institute Of Dental Sciences, Chinnakulambakam , Chengalpet district.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9962229886 |
| Fax |
|
| Email |
dr.lohiniofficial@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Hemalatha R |
| Designation |
Professor |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
room no : 7 , department of periodontics , Karpaga vinayaga institute of dental sciences, chinnakulambakam , chengalpet district.
TAMIL NADU
603308
India |
| Phone |
9884970030 |
| Fax |
|
| Email |
hemaarun21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Logalakxmi JK |
| Designation |
Post graduate |
| Affiliation |
Karpaga Vinayaga Institute of Dental Sciences |
| Address |
Room no : 7 , Department of Periodontics , Karpaga Vinayaga Institute Of Dental sciences, Chinnakulambakam , Chengalpet district.
TAMIL NADU
603308
India |
| Phone |
9962229886 |
| Fax |
|
| Email |
dr.lohiniofficial@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no :7, Department ofperiodontics, Karpaga Vinayaga Institute Of Dental Sciences,Chinnakulambakam,chengalpet district, pin code: 603308 |
|
|
Primary Sponsor
|
| Name |
karpaga vinayaga institute of dental sciences |
| Address |
room no : 7 , department of periodontics , Karpaga vinayaga institute of dental sciences, chinnakulambakam , chengalpet district. |
| Type of Sponsor |
Other [Dental College and Hospital] |
|
|
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 |
| Logalakxmi J K |
Karpaga Vinayaga Institute of Dental sciences |
Room no : 7 , Department of Periodontics , Karpaga Vinayaga Institute of Dental Sciences, Chinnakulambakam , Chengalpet district.
Kancheepuram
TAMIL NADU |
9962229886
dr.lohiniofficial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K061||Gingival enlargement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
laser |
980nm wavelength diode laser |
| Comparator Agent |
SCALPERL AND LASER |
980nm wavelength diode laser in laser gingivectomy group and 15 size blade in scalpel gingivectomy group |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
age 20 to 45 years old both male and female |
|
| ExclusionCriteria |
| Details |
subjects with systemic diseases,drug induced gingival enlargement, age more than 45 years |
|
|
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
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain and discomfort score in the baseline as 1st day itself |
Pain and discomfort score in the baseline as 1st day itself |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| healing in 7th post operative day |
healing score in 7th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 objective of the study is to compare scalpel based procedure and laser based procedure(gingivectomy); to compare which group has less pain and discomfort and which group has faster healing period. |