| CTRI Number |
CTRI/2025/01/079467 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
24/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
A comparative evaluation between laser and electrocautery in gingivectomy procedure |
|
Scientific Title of Study
|
Gingivectomy Procedure- Laser Vs Electrocautery: 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. Aarya Pandit |
| Designation |
Resident (Periodontology) |
| Affiliation |
Dharmsinh Desai University |
| Address |
Department of Periodontology
Faculty of Dental Science, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
99727780110 |
| Fax |
|
| Email |
dr.abp21@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Vasumati Patel |
| Designation |
Professor, Head of Department |
| Affiliation |
Dharmsinh Desai University |
| Address |
Faculty of Dental Science, College Road, Nadiad
Faculty of Dental Science, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8200210769 |
| Fax |
|
| Email |
pateldrvasu@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Aarya Pandit |
| Designation |
Resident (Periodontology) |
| Affiliation |
Dharmsinh Desai University |
| Address |
Department of Periodontology
Faculty of Dental Science, College Road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
99727780110 |
| Fax |
|
| Email |
dr.abp21@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Science, College Road, Nadiad, Kheda, India, 387001 |
|
|
Primary Sponsor
|
| Name |
Dharmsinh Desai University |
| Address |
Faculty of Dental Science, College Road, Nadiad, Kheda, India, 387001 |
| Type of Sponsor |
Research institution 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 |
| Dr Aarya Pandit |
Dharmsinh Desai University |
Department of Periodontology, Faculty of Dental Science, College Road, Nadiad, Kheda,387001
Kheda
GUJARAT |
9727780110
dr.abp21@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 |
| Patients |
(1) ICD-10 Condition: K061||Gingival enlargement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ELECTROCAUTERY |
Using a 50 Hz radio frequency advanced cautery, the marked area will be excised. The area will be examined for any tissue tags or remnants. The application of electrocautery shall end once ideal crown height is achieved. Following this, periodontal dressing shall be given, and the patient shall be recalled for consequent scheduled follow ups at 3 days, 1 week, 2 week and 4 weeks. |
| Intervention |
Laser |
A 400-µm disposable tip, set to 0.8-1.5 watts, will be gently used in a paintbrush motion to remove the marked tissue and reveal enough tooth structure. The area will be carefully checked for any tissue remnants, which will be cleaned, and high-volume suction will be used to clear the laser plume and odor.
The application of intervention shall end once ideal crown height is achieved. Following this, periodontal dressing shall be given, and the patient shall be recalled for consequent scheduled follow ups at 3 days, 1 week, 2 week and 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in need of crown lengthening procedures for prosthetic or aesthetic concern
2.Patients having pseudo pockets.
3.Supra-bony pocket
4.Patients with gingival enlargements without bone loss.
5.Width of attached gingiva should be adequate.
6.Patients with good oral hygiene
7.Patients willing to participate in the study by giving written consent.
|
|
| ExclusionCriteria |
| Details |
1.Patients where elimination of pocket or crown lengthening requires access to
bone (osseous reduction).
2.Patients having uncontrolled systemic diseases where surgery is contraindicated
3. Pregnant and lactating women
4. Untreated periodontitis
5. Use of any drugs that might lead to gingival enlargement or that may affect
the outcome of the treatment. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival margin position, Probing depth, Healing index, |
Baseline, 1 Week, 2 Weeks, 4 Weeks.
Probing depth at baseline and 4 weeks only |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| GINGIVAL INDEX, PLAQUE INDEX, VERBAL ANALOGUE SCALE FOR PAIN AN DISCOMFORT |
BASELINE, 1 WEEK, 2 WEEKS, 4 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/02/2025 |
| Date of Study Completion (India) |
30/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.abp21@gmail.com].
- For how long will this data be available start date provided 20-09-2025 and end date provided 20-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study shall compare the effectiveness of diode laser and electrocautery for gingivectomy in patients with pseudo pockets and gingival enlargement. It will be conducted as a randomized, split-mouth clinical trial involving 30 patients who meet the specified inclusion criteria. Various clinical parameters, including probing depth, gingival margin position, plaque index, gingival index, healing index, and patient-reported pain and discomfort, will be evaluated at baseline and over follow-up periods. The research aims to identify which technique offers superior outcomes regarding healing, pain management, and overall patient experience. The findings will contribute to improving clinical decision-making, providing dentists with evidence-based recommendations for selecting the most suitable technique. This research has the potential to advance periodontal surgery by optimizing patient care, minimizing discomfort, and ensuring effective management of gingival enlargement. |