| CTRI Number |
CTRI/2024/07/070017 [Registered on: 04/07/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
low level laser therapy on gums |
|
Scientific Title of Study
|
Comparison Of Soft Tissue Healing After Conventional Gingivectomy Procedure With And Without Low-Level Laser Therapy (LLLT) - 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. Ekta Anant Patil |
| Designation |
Post Graduate student |
| Affiliation |
Dr. G.D.POL. Foundation YMT Dental College and Hospital |
| Address |
1/A/16 Neelkanth Jyot Tilak Nagar Dombivli East
G.D.POL. Foundation YMT Dental College and Hospital Kharghar Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
421201
India |
| Phone |
9867742976 |
| Fax |
|
| Email |
patil.ekta16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Ekta Anant Patil |
| Designation |
Post Graduate student |
| Affiliation |
Dr. G.D.POL. Foundation YMT Dental College and Hospital |
| Address |
1/A/16 Neelkanth Jyot Tilak Nagar Dombivli East
Dr. G.D.POL. Foundation YMT Dental College and Hospital Kharghar Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
421201
India |
| Phone |
9867742976 |
| Fax |
|
| Email |
patil.ekta16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ekta Anant Patil |
| Designation |
Post Graduate student |
| Affiliation |
Dr. G.D.POL. Foundation YMT Dental College and Hospital |
| Address |
1/A/16 Neelkanth Jyot Tilak Nagar Dombivli East
Dr. G.D.POL. Foundation YMT Dental College and Hospital Kharghar Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA
421201
India |
| Phone |
9867742976 |
| Fax |
|
| Email |
patil.ekta16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. G.D.POL. Foundation YMT Dental College and Hospital Institutional area, sector 4, Kharghar, Navi Mumbai,Maharashtra,India 410210 |
|
|
Primary Sponsor
|
| Name |
Dr. Eta Anant Patil |
| Address |
A7-204 RUTU ENCLAVE ANANDNAGAR KASARVADAVLI GHODBUNDER ROAD THANE WEST , 400615 |
| 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 |
| Dr Rizwan Sanadi |
Dr. GD Pol Foundation YMT Dental college and Hospital |
Dr. GD Pol Foundation YMT Dental college and Hospital, Dept. no. 3,Department of Periodontology,Kharghar sector 4, Navi Mumbai
Mumbai (Suburban)
MAHARASHTRA |
9730858235
drriz28@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee YMT Dental College Kharghar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Gingivectomy |
Bleeding points will be marked on the external surface of the gingiva corresponding to the depth of the pseudopockets, at mesiobuccal, midbuccal and distobuccal surfaces using a pocket marker. The external bevel incision (continuous or discontinuous) will be placed apical to the marked bleeding points at approximately 45 degrees to the long axis of the tooth surface. The gingival tissue will be excised, so as to re-create the normal festooned pattern of the gingiva. |
| Intervention |
Low Level Laser Therapy |
The test sites will be irradiated with a diode laser using 1.00W output power, wavelength 810 nm (visible emission), continuous wave, and beam diameter of 2 mm and irradiation will be made in non-contact mode, scanning an area of about 1cm2 for 10 sec while holding the delivery tip perpendicular to the tissue surface. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy cooperative subjects,Age group of 15-45 years of either sex, presence of gingival overgrowth with or without presence of pseudopocket |
|
| ExclusionCriteria |
| Details |
Drug induced gingival enlargement, Pregnant and lactating women, Smokers and tobacco chewers.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of low-level laser therapy (LLLT) on soft tissue healing after conventional gingivectomy procedure. |
baseline 1 week 2 week 1month 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of low-level laser therapy (LLLT) on reduction in gingival inflammation, pain, discomfort & number of analgesics taken after conventional gingivectomy procedure. |
baseline 1 week 2 week 1month 3 months |
|
|
Target Sample Size
|
Total Sample Size="27"
Sample Size from India="27"
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 3 |
|
Date of First Enrollment (India)
|
10/07/2024 |
| 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="3"
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 the efficacy of low level laser therapy
for acceleration of healing post gingivectomy in patients.the sample size of 27
sites for cases and control each are taken.gingival enlargement is one of the
frequent features of gingival diseases. However due to their varied
presentations, the diagnosis of these entities becomes challenging for the
clinician. They can be categorized based on their etiopathogenesis, location,
size, extent, etc. A perfect diagnosis is critically important, since the
management of these lesions and prevention of their recurrence is completely
dependent on it. The follow up of patient at baseline 1 week 2 week 1month and
3 months is done |