| CTRI Number |
CTRI/2023/05/052243 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Low Level Laser therapy after scalpel gingivectomy |
|
Scientific Title of Study
|
Wound Healing and Pain Assessment Following Low Level Laser Therapy After gingivectomy procedure: A Randomized Controlled Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kshipra kawadkar |
| Designation |
Post Graduate Student |
| Affiliation |
VYWS Dental College and Hospital |
| Address |
VYWS Dental College and Hospital Amravati Tapovan Wadali Road Amravati 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
9404693955 |
| Fax |
|
| Email |
kshipra.kawadkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Parwani |
| Designation |
HOD and Professor department of periodontology |
| Affiliation |
VYWS Dental College and Hospital |
| Address |
VYWS Dental College and Hospital Amravati Tapovan Wadali Road Amravati 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
9977132697 |
| Fax |
|
| Email |
simpar74@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kshipra kawadkar |
| Designation |
Post Graduate Student |
| Affiliation |
VYWS Dental College and Hospital |
| Address |
VYWS Dental College and Hospital Amravati Tapovan Wadali Road Amravati 444602
Amravati
MAHARASHTRA
444602
India |
| Phone |
9404693955 |
| Fax |
|
| Email |
kshipra.kawadkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| VYWS DENTAL COLLEGE AND HOPSITAL, AMRAVATI |
|
|
Primary Sponsor
|
| Name |
Dr Kshipra P Kawadkar |
| Address |
VYWS dental college and hopsital, tapovan camp, amravati-444602 |
| Type of Sponsor |
Other [self-sponsored] |
|
|
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 |
| KSHIPRA |
VYWS DENTAL COLLEGE |
DEPARTMENT OF PERIODONTOLOGY, ROOM NO 16, 1st FLOOR, VYWS DENTAL COLLEGE, AMRAVATI
Amravati
MAHARASHTRA |
9404693955
kshipra.kawadkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-VYWSDCHA |
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 |
Low level laser therapy after scalpel gingivectomy ( intervention group) |
to evaluate efficacy of laser in wound healing after scalpel gingivectomy on 1st,3rd, 15th and 1 month post-operatively |
| Comparator Agent |
Scalpel ginivectomy (control group) |
to evaluate efficacy of scalpel gingivectomy alone on 1st, 3rd, 15th and 1 month post-operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Cases indicated for gingivectomy procedure in maxillary and mandibular anterior region.
2) Inflammatory and non-inflammatory gingival enlargement excluding drug induced enlargements.
3) Patients with no systemic diseases and have no history of medication in last six months.
4) Participants having good oral hygiene.
5) Patient willing to participate in the research.
|
|
| ExclusionCriteria |
| Details |
1) Pregnancy
2) History of any drug usage affecting the periodontium for the past 6 months
3) Previous periodontal treatment for the last 6 months
4) Patient with bleeding disorders
5) Smoking
6) Teeth with untreated caries, endodontic lesions and grade II or more mobility
7) Subjects with Acute exacerbation of periodontitis, herpetic lesions and Necrotizing Ulcerative Periodontitis (NUG)
8) Uncooperative patients
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate pain response after scalpel gingivectomy and LLLT versus Scalpel gingivectomy alone.
2) To assess wound healing after scalpel gingivectomy and LLLT versus Scalpel gingivectomy alone.
3) To measure degree of keratinization after scalpel gingivectomy and LLLT versus Scalpel gingivectomy alone.
|
1st day, 3rd day, 15th day and 1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="13"
Sample Size from India="13"
Final Enrollment numbers achieved (Total)= "13"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/05/2023 |
| Date of Study Completion (India) |
21/07/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Low-level laser therapy (LLLT) focused on bio stimulation/biomodulation effect, at specific wavelength, leads to modification of cellular activities. Aim: This split-mouth study was used to assess effect of LLLT after scalpel gingivectomy, using diode laser on patient’s pain response; immediately after wearing off of local anesthetic effect; on first day followed by wound healing and degree of keratinization on third day, 15th day and after one month post-operatively. Materials and methods: Thirteen patients with twenty-six sites exhibiting gingival enlargement in maxillary and mandibular regions will be included. Following scalpel gingivectomy, diode laser with 980 nm wavelength at 3W power in pulsed non-contact mode at gingivectomy treatment function will be used. Test region tissues (randomly allotted by lottery method) will be lased 1-2 cm away from surgical wound on the day of gingivectomy. Surgical areas of control and test groups will be disclosed with methylene blue to visualize the areas where the epithelium was present. Results: LLLT�’applied sites will be compared statistically with control surgical sites in terms of Wong Bakers faces pain scale, Huang et al.’s wound healing index and degree of keratinization. |