| CTRI Number |
CTRI/2026/04/107553 [Registered on: 02/04/2026] Trial Registered Prospectively |
| Last Modified On: |
03/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of pain after single visit root canal treatment in Lase group and control group. |
|
Scientific Title of Study
|
EFFECT OF AN 810 NM DIODE LASER ON POST OPERATIVE PAIN
AFTER SINGLE-VISIT ROOT CANAL TREATMENT IN TEETH WITH
APICAL PERIODONTITIS: 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 |
Gargi Das |
| Designation |
PGT |
| Affiliation |
Awadh Dental College and hospital |
| Address |
Awadh Dental College And Hospital National Highway 18
Dept. of conservative dentistry and endodontics
Room no-3
Purbi Singhbhum
JHARKHAND
831012
India |
| Phone |
08250075919 |
| Fax |
|
| Email |
imgargidas@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swarupananda Bera |
| Designation |
Professor |
| Affiliation |
Awadh Dental College and hospital |
| Address |
Awadh Dental College And Hospital National Highway 18
Dept.of Conservative Dentistry and endodontics.
Purbi Singhbhum
JHARKHAND
831012
India |
| Phone |
08250075919 |
| Fax |
|
| Email |
drsnbera@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gargi Das |
| Designation |
PG student |
| Affiliation |
Awadh Dental College and hospital |
| Address |
Awadh Dental College And Hospital National Highway 18
Dept. of conservative dentistry and endodontics.
Room no-3
Purbi Singhbhum
JHARKHAND
831012
India |
| Phone |
08250075919 |
| Fax |
|
| Email |
imgargidas@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Awadh Dental College and Hospital |
| Address |
Jamshedpur
Jharkhand
Pin-831012 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 |
| Gargi Das |
Awadh Dental College and Hospital |
Dept of conservative Dentistry and endodontics
Room no-3
Purbi Singhbhum
JHARKHAND |
08250075919
imgargidas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Awadh Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K044||Acute apical periodontitis of pulpal origin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
810 nm diode laser |
apllied in root canal for 15 s after BMP |
| Comparator Agent |
Its Laser not drug |
810 nm diode laser in post operative pain.Pain persistence with laser group and placebo group ] |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
60 healthy patients who satisfied the requirements for inclusion were chosen. This study only included
patients with a PAI score of 3 and asymptomatic teeth. Radiographic and clinical investigations were
conducted in order to get a diagnosis. |
|
| ExclusionCriteria |
| Details |
The criteria for exclusion included using antibiotics within the previous month, having systemic disorders,
being pregnant or nursing, having traumatic occlusions, having other teeth that need root canal therapy,
teeth having root canal fillings, having calcified canals, having root resorption, having periodontal
involvement or sinus tracts |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Low pain on Laser group than placebo group |
1 week |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/05/2026 |
| Date of Study Completion (India) |
24/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Trying for publication |
|
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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 - 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 (Others) - collected in the XL sheet
- For how long will this data be available start date provided 02-01-2025 and end date provided 02-01-2026?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
Brief Summary
Modification(s)
|
This study was included 60 healthy patients with the need of endodontic treatment in their maxillary 1st premolar with periapical index score 3. After irrigation of each canal with 5.2% sodium hypochlorite canals were dried with paper points. ^0 patients were randomly divided into two groups. 1. Laser Group (n=30): An 810 nm diaode laser activated into canals 1mm short of the working length with 20ms Pulse duration for 15 s followed by 10 s lapse. This procedure was repeated thrice. 2. Placebo Group (n=30)= Laser tip was not activated. After that all root canals were obturated followed by post operative restoration with composite. Then patients were contacted over phone calls and asked about the pain and number analgesic was taken after 24h, 48h and 7d. Pain was scoring by Visual Analogue scale. Statistically Analysed by chi square test. |