| CTRI Number |
CTRI/2023/04/051873 [Registered on: 21/04/2023] Trial Registered Prospectively |
| Last Modified On: |
13/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Laser therapy to reduce post endodontic pain in primary teeth |
|
Scientific Title of Study
|
Evaluation of post endodontic pain and frequency of analgesic intake after low level laser therapy in patients with symptomatic irreversible pulpitis in primary molar: a double blind randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammed Salman Ali |
| Designation |
MDS Student |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room No 3, Department of Pedodontics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
9066454214 |
| Fax |
|
| Email |
salmanali458@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DEEPAK BM |
| Designation |
READER |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room No 3, Department of Pedodontics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
9844058600 |
| Fax |
|
| Email |
dr.deepakbm@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Mohammed Salman Ali |
| Designation |
MDS Student |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room No 3, Department of Pedodontics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA
577004
India |
| Phone |
9066454214 |
| Fax |
|
| Email |
salmanali458@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pedodontics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere - 577004
|
|
|
Primary Sponsor
|
| Name |
Mohammed Salman Ali |
| Address |
Room No 3, Department of Pedodontics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere |
| 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 |
| Mohammed Salman Ali |
Bapuji Dental College and Hospital |
Room No 3, Department of Pediatrics And Preventive Dentistry, Bapuji Dental College And Hospital, Davanagere
Davanagere
KARNATAKA |
9066454214
salmanali458@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD, BAPUJI DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional pulpectomy |
without laser irradiation |
| Intervention |
conventional pulpectomy with Low Level Laser Therapy |
Laser irradiation with single dose of 810 nm wavelength with power of 100 mW for 160 seconds |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
- symptomatic irreversible pulpitis in primary molars
- symptomatic pulpitis with spontaneous pain or lingered by cold or heat
- mobility less than 1 |
|
| ExclusionCriteria |
| Details |
- absence of bleeding after pulpal exposure (necrotic teeth)
- no responds to cold and heat test
- lidocaine hypersensitivity
- children who have taken antibiotic or analgesic before 6 hrs of treatment |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| evaluation of post endodontics pain and frequency of analgesic intake |
evaluation of post endodontics pain and frequency of analgesic intake at 24 hours and 48 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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
|
N/A |
|
Date of First Enrollment (India)
|
21/04/2023 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
no |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, parallel group, single centre trial comparing the post endodontic pain and frequency of analgesic intake after low level laser therapy in patients with symptomatic irreversible pulpitis in primary molars will be conducted at Bapuji Dental College and Hospital, Davangere, Karnataka, India. Single visit pulpectomy will be carried out for each individual followed which in intervention group low level laser therapy will be given and in control group no laser therapy will be given. Patients will be evaluate at 24 hours and 48 hours for post endodontic pain and frequency of analgesic intake. |