| CTRI Number |
CTRI/2024/06/068900 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying how laser treatment affects pain and healing after root canal treatment: A clinical trial |
|
Scientific Title of Study
|
Clinical Evaluation of the effect of Diode laser activated irrigation on post-operative pain and resolution of periapical lesion after endodontic therapy: 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 Palak J Gandhi |
| Designation |
PG student |
| Affiliation |
Government Dental College & Hospital, Jamnagar |
| Address |
203, second floor, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Jamnagar, Pathikashram Main Road, Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7303125128 |
| Fax |
|
| Email |
palakjg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Leena Jobanputra |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College & Hospital, Jamnagar |
| Address |
Department of Conservative Dentistry and Endodontics, Pathikashram Main road, Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9879503545 |
| Fax |
|
| Email |
lihiren@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Palak J Gandhi |
| Designation |
PG student |
| Affiliation |
Government Dental College & Hospital, Jamnagar |
| Address |
203, second floor, Department of Conservative Dentistry and Endodontics, Government Dental College and Hospital, Jamnagar, Pathikashram Main Road, Navagam, Jamnagar, Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
7303125128 |
| Fax |
|
| Email |
palakjg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Jamnagar, Pathikashram Main Road, Navagam, Jamnagar, Gujarat 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Palak J Gandhi |
| Address |
203, Second floor, Department of Conservative Dentistry & Endodontics, Government Dental college & Hospital, Jamnagar, Pathikashram Main road, Navagam, Jamnagar, Gujarat 361008 |
| 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 Palak J Gandhi |
Government Dental College and Hospital, Jamnagar |
203, second floor, Department of Conservative Dentistry and Endodontics
Jamnagar
GUJARAT |
7303125128
palakjg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, M.P. Shah Medical College and Guru Gobind Singh Hospital, Jamnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Irrigation protocol assisted with laser activation |
Immediately after full biomechanical preparation, laser activation of 3% sodium hypochlorite will be done using epic x biolase laser using 200 micrometer fibre laser tips |
| Comparator Agent |
Irrigation protocol without laser activation |
Immediately after complete biomechanical preparation, irrigation will be done using 3% sodium hypochlorite which will not be activated followed by saline and final rinse with EDTA liquid follwing which obturation will be done |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients between the age group of 18 – 60 years.
2. Physically and mentally healthy patients.
3. Maxillary and mandibular single-rooted teeth.
4. Clinically negative response or no tenderness on percussion.
5. No response on cold and EPT pulp sensibility testing.
6. Patients Diagnosed with symptomatic apical periodontitis.
7. Radiographically presence of periapical radiolucency of 2-4 mm size.
8. Patients who gave consent for treatment and follow-up.
9. Patients who were ready to participate in the study.
|
|
| ExclusionCriteria |
| Details |
systemically handicapped patients
multirooted teeth
wheeping canal
large periapical lesion
retreatment cases
patients taking antibiotics or immunosuppressive drugs six months before study
pregnancy or lactation
smoking or alcoholism |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of post operative pain and resolution of periapical lesion |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time required for the resolution of the lesion to interpret the effectiveness of the treatment |
1 year |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
15/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [palakjg@gmail.com].
- For how long will this data be available start date provided 10-11-2025 and end date provided 10-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Background: After any initiated root canal procedure, chances of pain are present which may last for 2-5 days post the treatment. Also, after effective appropriate root canal procedure, the periapical lesion should resolve over a period of time
Purpose: This randomized clinical trial aims to assess the effectiveness of laser assisted irrigation in the reduction of post operative pain and also in resolution of periapical lesion. By comparing outcomes with conventional method, we aim to identify the optimal approach for improving patient comfort and treatment success rate in endodontic practice. |