| CTRI Number |
CTRI/2025/04/085380 [Registered on: 23/04/2025] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Comparison of two tools used to remove decay in primary teeth and to check how efficient the tool is and how much pain patient experiences during procedure. |
|
Scientific Title of Study
|
Comparative Evaluation of Caries Excavation Efficiency and Pain Perception of Patient Using CeraBur and Ultrasonic Oscillating Tips in Primary Molars: A Randomized Clinical 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 Mrunal Borawake |
| Designation |
Post-graduate student |
| Affiliation |
K. M. Shah Dental College and Hospital Vadodara |
| Address |
No.3 Department of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7378870704 |
| Fax |
|
| Email |
mrunalborawake@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonacha K S |
| Designation |
Professor |
| Affiliation |
K. M. Shah Dental College and Hospital Vadodara |
| Address |
No.3 Department of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9725036673 |
| Fax |
|
| Email |
poochi2263@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mrunal Borawake |
| Designation |
Post-graduate student |
| Affiliation |
K. M. Shah Dental College and Hospital Vadodara |
| Address |
No.3 Department of Pediatric and Preventive Dentistry K M Shah Dental College and Hospital Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
7378870704 |
| Fax |
|
| Email |
mrunalborawake@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Vadodara, 391760 |
|
|
Primary Sponsor
|
| Name |
Dr. Mrunal Borawake |
| Address |
K M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Vadodara,391760 |
| 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 Mrunal Borawake |
K M Shah Dental College and Hospital |
No 3, Department of Pediatric and Preventive Dentistry, K M Shah Dental College and Hospital, Vadodara
Vadodara
GUJARAT |
7378870704
mrunalborawake@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K025||Dental caries on pit and fissure surface, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CeraBur |
Ceramic bur utilized in slow speed handpiece under water coolant will be used for caries excavation and pain perception will be assessed. |
| Comparator Agent |
SB1 Tip |
SB1 ultrasonic oscillating tip attached to a scaler unit will be used for caries excavation and pain perception will be assessed |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants between 4-9 years of age will be included.
2. Participants who have occlusal carious lesions in atleast two primary molars and located contralaterally either in maxilla or mandible.
3. The teeth will be selected based on Mount and Hume classification number 1.2.
4. Participants whose parents will give written consent for the study.
5. Participants with Frankel’s behaviour rating scale 3 and 4
|
|
| ExclusionCriteria |
| Details |
1. Molars with one or more of the following clinical or radiological signs and symptoms: pulpal, periodontal, and soft tissue pathology in relation to involved teeth.
2. Non vital teeth.
3. Children with systemic disease and congenital abnormality.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Evaluation of pain perception of patients for caries removal while using CeraBur and Ultrasonic oscillating tip |
Pain assessment will be done using Modified Wong Baker Pain Rating Scale on the first visit and after 7 days of washout period, on the second visit same parameter as above will be assessed |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of time taken for caries removal while using CeraBur and Ultrasonic oscillating tip |
Time taken will be assessed using stopwatch from start of the procedure till infected dentin is removed |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
15/07/2025 |
| 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="1"
Months="6"
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
|
To
compare and evaluate caries excavation efficiency and pain perception of patients
while using CeraBur and Ultrasonic oscillating tip in primary molars.
OBJECTIVES:
1.
To assess and compare the caries removal efficiency of CeraBur
and Ultrasonic oscillating tip in primary molars.
2. To
assess and compare the pain perception of patients during caries excavation
while using CeraBur and Ultrasonic oscillating tip using Modified Wong
Baker’s pain rating scale. |