| CTRI Number |
CTRI/2025/08/092930 [Registered on: 12/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing How Well Different Dental Tools Work and How Comfortable They Feel for Kids Aged 6–8 During Cavity Treatment A Randomized Study |
|
Scientific Title of Study
|
Comparative evaluation of assessing caries removal efficiency and pain perception in 6-8 years old children using carbide bur, diamond burs, smart bur and ceramic bur: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 |
Kareena Singh |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital Debari Udaipur |
| Address |
Department of Pediatric and Preventive Dentistry room no 9 pacific dental college and hospital debari pacific dental college and hospital debari udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
9099125725 |
| Fax |
|
| Email |
dr.skareena099@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of Department PG Guide |
| Affiliation |
Pacific Dental College And Hospital Debari |
| Address |
Department of pediatric and preventive dentistry room no 9 pacific dental college and hospital debari Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
07340659914 |
| Fax |
|
| Email |
Pedodinesh2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrDinesh Rao |
| Designation |
Head of Department PG Guide |
| Affiliation |
Pacific Dental College And Hospital Debari |
| Address |
Department of paediatric and preventive dentistry room no.9 pacific dental college and hospital,debari, Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
07340659914 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of pediatric and preventive dentistry room no 9 Pacific Dental College And Hospital Debari Udaipur Rajasthan 313024 |
|
|
Primary Sponsor
|
| Name |
Kareena Singh |
| Address |
Department of pediatric dentistry room no 9 pacific dental college and hospital
pacific dental college and hospital debari Udaipur rajasthan 313024 |
| Type of Sponsor |
Other [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 |
| Dinesh Rao |
Pacific dental college and hospital debari udaipur |
Department of pediatric and preventive dentistry room no 9 Pacific Dental College and Hospital debari, Udaipur RAJASTHAN
Udaipur
RAJASTHAN |
9414158235
pedodinesh2003@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| pacific dental college and hospital, debari Udaipur |
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 |
| Comparator Agent |
Carbide bur
|
caries removal efficiency and pain perception of diamond bur, smart bur and ceramic bur will be compared with carbide bur
|
| Intervention |
carbide bur
diamond bur
smart bur
ceramic bus |
caries removal will be done with carbide bur, diamond bur, smart bur and ceramic bur and checked after the caries removal and pain perception will be checked with pain rating scales before and after the procedure |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative children aged between 6 to 8 years Frankl rating 3 or 4
Children with good physical and mental health without any history of systemic disease
Presence of at least one occlusal carious lesion involving dentinal caries without pulpal involvement in mandibular primary molars indicated for restorative treatment
Mandibular primary molars fulfilling international caries detection and assessment system code 4
Mandibular primary molars using radiographs fulfilling international caries classification and management system RB4 radiolucency reaching the middle one-third of dentin
|
|
| ExclusionCriteria |
| Details |
Non-cooperative children Frankl rating 1 or 2
Deep carious lesions with pulpal involvement
Teeth that have previous restorations or partially excavated caries in the same lesion
Children with cognitive impairments mental disabilities or special health care needs that affect their ability to undergo standard dental procedures
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Caries Removal Efficiency
Pain Perception
|
Caries Removal Efficiency
Pain Perception caries will be checked immediately after the procedure and pain will be checked before and after the procedure
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time Taken for Caries Removal
Childs Behavior
postoperative sensitivity |
time taken for caries removal from start of the procedure till the caries are excavated
childs behaviour before & after the procedure
postoperative sensitivity after 24hours of the procedure by taking follow up |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/08/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Dental caries is one of the most common chronic conditions affecting children globally, particularly between 6 to 8 years of age. Effective caries removal with minimal discomfort is essential in pediatric dentistry to ensure child cooperation and prevent dental fear. Conventional burs such as carbide and diamond are efficient but often cause pain and anxiety. Newer minimally invasive instruments like smart burs and ceramic burs offer promising alternatives by preserving healthy dentin and reducing pain. This randomized clinical trial aims to compare four types of burs—carbide, diamond, smart, and ceramic—in terms of caries removal efficiency and pain perception in 6–8-year-old children. Eighty cooperative children with occlusal dentinal caries in mandibular primary molars will be randomly assigned to one of the four groups. Pain will be assessed using the Wong-Baker FACES scale and FLACC scale, while clinical effectiveness will be evaluated using caries detection dye and a validated scoring system. The time taken for caries removal and the behavioral response (Frankl scale) will also be recorded. The study is designed to provide evidence-based recommendations for pediatric dentists in selecting child-friendly caries excavation methods that balance clinical efficiency with patient comfort. |