| CTRI Number |
CTRI/2025/01/079286 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
20/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Pain Relief Using Intra-Pulpal and Laser-Assisted Anesthesia in Single-Visit Root Canal Treatment for Mandibular Molars |
|
Scientific Title of Study
|
Comparing the Effects of Intra-pulpal and LASER-assisted Local Anesthesia on Intra and Postoperative Pain following Single visit Root Canal Treatment for Mandibular Molars with Symptomatic Irreversible Pulpitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Muthukumaran M |
| Designation |
postgraduate student |
| Affiliation |
CSI college of Dental Sciences and Research |
| Address |
Room No 6,CSI College of Dental Sciences and Research ,
Department of Conservative Dentistry and Endodontics,129 CMH
Compound ,East Veli Street,
Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
7339417885 |
| Fax |
|
| Email |
muthukumaran851997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of operative dentistry and endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room No 6,CSI College of Dental Sciences and Research ,
Department of Conservative Dentistry and Endodontics,129 CMH
Compound ,East Veli Street, Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr I Anand Sherwood |
| Designation |
HOD and Professor of operative dentistry and endodontics |
| Affiliation |
CSI College of Dental Sciences and Research |
| Address |
Room No 6,CSI College of Dental Sciences and Research ,
Department of Conservative Dentistry and Endodontics,129 CMH
Compound ,East Veli Street, Madurai
Madurai
TAMIL NADU
625001
India |
| Phone |
9443805150 |
| Fax |
|
| Email |
anand.sherwood@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 6,
Department of conservative dentistry and endodontics,
CSI College of Dental Sciences and Research,
129, CMH compound,
East veli street,
Old Kuyavar palayam road,
Madurai - 625001
Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Muthukumaran M |
| Address |
Room no 6 , Department of operative dentistry and endodontics ,CSI
College of dental sciences and research , 129 CMH Compound ,East
Veli Street ,Madurai 625001 |
| 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 |
| Muthukumaran M |
Muthukumaran M |
Room no. 6,
Department of conservative dentistry and endodontics,
CSI College of Dental Sciences and Research,
129, CMH compound,
East veli street,
Old Kuyavar palayam road,
Madurai - 625001
Tamilnadu, India
Madurai
TAMIL NADU |
7339417885
muthukumaran851997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee and Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diode laser |
single visit root canal treatment using diode laser anesthesia for 30 - 60 seconds approx. |
| Comparator Agent |
Intra-pulpal anaesthesia |
single visit root canal treatment using lignocaine with Adrenaline[ 1:80000]intra-pulpal anaesthesia for 30 - 60 seconds approx., |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Age between 13-70 years
Pain due to symptomatic irreversible pulpitis from carious mandibular first and second molar teeth requiring root canal treatment were evaluated as possible candidates for this study.
|
|
| ExclusionCriteria |
| Details |
Absence of pain upon gaining access to the pulp following local anesthetic administration
Teeth with poor periodontal or restorative prognosis
Patients not willing to participate in the post-operative recall evaluation
Any anatomic variation such as extra roots or root canals, C-shaped roots, and patients with a history of allergy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effectiveness of applying intrapulpal anesthesia and laser therapy directly to the pulp chamber in managing intra-operative pain following inferior alveolar nerve block in mandibular molar teeth with symptomatic irreversible pulpitis.
|
During root canal treatment procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate their post-operative pain levels following the use of intra-pulpal anesthesia & laser application in single-visit root canal treatment. |
24 hours, 48 hours following Single visit root canal treatment |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 - NO
|
|
Brief Summary
|
The present clinical evaluation was planned for comparing the efficacy of intrapulpal anaesthesia and diode laser assisted anaesthesia for single visit root canal treatment and monitoring the intraoperative and postoperative pain after single visit root canal treatment |