| CTRI Number |
CTRI/2025/07/091525 [Registered on: 23/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study of laser photobiomodulation synergy with lignocaine and tramadol to increase depth of anesthesia |
|
Scientific Title of Study
|
Laser photobiomodulation synergy with lignocaine and tramadol An In vivo study |
| 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 Shlesha Sheth |
| Designation |
Post Graduate Student |
| Affiliation |
Narsinhbhai Patel Dental college and hospital |
| Address |
S P Sahakar Vidhyadham Ambaji Gandhingar Link Road Near Kamana Char Rasta Visnagar Gujarat
Room No 5 department of conservative dentistry and endodontics Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University
Mahesana
GUJARAT
384315
INDIA
Mahesana
GUJARAT
384315
India |
| Phone |
9408951168 |
| Fax |
|
| Email |
sheth.shlesha09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and head |
| Affiliation |
Narsinhbhai Patel Dental college and hospital |
| Address |
room no 5 Department of Conservative Dentistry And Endodontics Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University
Visnagar
Gujarat
384315
INDIA
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kailash Attur |
| Designation |
Professor and head |
| Affiliation |
Narsinhbhai Patel Dental college and hospital |
| Address |
room no 5 Department of Conservative Dentistry And Endodontics Narsinhbhai Patel Dental College and Hospital Sankalchand Patel University
Visnagar
Gujarat
384315
INDIA
Mahesana
GUJARAT
384315
India |
| Phone |
9727752499 |
| Fax |
|
| Email |
atturkailash@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Conservative Dentistry and Endodontics Narsinhbhai Patel Dental College and Hospital visnagar
384315
mahesana
Gujarat
India |
|
|
Primary Sponsor
|
| Name |
Dr Shlesha Sheth |
| Address |
9, killol bungalows gayatri nagar society , nanakwada valsad 396001
Gujarat
India |
| 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 Shlesha Sheth |
Narsinhbhai Patel Dental college and hospital |
Room no 5 Department of Conservative dentistry and Endodontics Narsinhbhai Patel Dental College and Hospital Nootan Dental college Visnagar , Mehsana Gujarat
Mahesana
GUJARAT |
9408951168
sheth.shlesha09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Narsinhbhai Patel Dental College Visnagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
evaluate depth of anesthesia during the root canal treatment procedure only.(2 hours) |
with tramadol and lignocaine during the root canal treatment procedure only (2 hours) |
| Comparator Agent |
with and without laser photobiomodulation during the root canal treatment procedure only.(2 hours) |
to evaluate increase in anesthetic efficacy with laser photobiomodulationduring the root canal treatment procedure only.(2 hours) |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Vital Maxillary Molar requiring Root Canal Treatment.
Vitality Test : Positive or prolonged response (Using Cold test & Electric pulp test)
|
|
| ExclusionCriteria |
| Details |
Non-Vital teeth.
All other maxillary teeth.
Mandibular teeth.
Teeth with periapical lesion.
Patients allergic to lignocaine (local anesthetics).
Pregnant & lactating women.
Patients having habit of alcohol.
Those who have systemic diseases, immunocompromised conditions, psychiatric condition
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Photobiomodulation increases depth of anesthesia during access cavity preparation. |
Visual analogue scale(VAS) for pain perception recorded during dentin cutting (VAS 1) and at entry into the pulp (VAS 2). The patient’s response will be noted based on VAS score during dentin cutting, and during pulp dropping(assessment while ongoing root canal treatment within 2hours of anesthesia delivery) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Chances of achievement of Pulpal anesthesia increases when tramadol hydrochloride & lignocaine hydrochloride both are administered. |
Visual analogue scale(VAS) for pain perception recorded during dentin cutting (VAS 1) & at entry into the pulp (VAS 2). The patient’s response will be noted based on VAS score during dentin cutting, & during pulp dropping while ongoing root canal treatment only.( within 2 hours of anaesthesia delivery) |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
15/08/2025 |
| 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="8"
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
|
Total of 80 vital maxillary molar teeth requiring root canal treatment
All the teeth are allocated in 4 groups as per anesthesia and laser photobiomodulation Infiltration anesthesia will be given . Lignocaine(0.6ml) Tramadol(0.4ml) | Group 1 | Lignocaine plus Tramadol | | Group 2 | Lignocaine plus Photobiomodulation | | Group 3 | Tramadol plus Photobiomodulation | | Group 4 | Lignocaine plus Tramadol plus Photobiomodulation |
Endo access bur will be used for access cavity preparation and while performing the treatment for each group, the evaluation was repeated and the Visual Analog scale VAS recorded during dentin cutting VAS 1 and at entry into the pulp VAS 2. The patient’s response will be noted based on VAS score during dentin cutting, and during pulp dropping |