| CTRI Number |
CTRI/2024/05/066705 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare the effectiveness of three different burs for caries removal in primary back tooth among children aged 4 to 8 years |
|
Scientific Title of Study
|
Comparative evaluation of effectiveness of ceramic burs, polymer burs with carbide burs for caries excavation in primary molars among children aged 4-8 years- A randomized clinical trial |
| 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 Aishwarya Arunkumar Patil |
| Designation |
Post Graduate Student |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences,
JNMC Campus, Nehru Nagar,
Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845585416 |
| Fax |
|
| Email |
aishwaryaarunpatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidyavathi H Patil |
| Designation |
Reader |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences,
JNMC Campus, Nehru Nagar,
Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9611835828 |
| Fax |
|
| Email |
nisarga_vhp@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Arunkumar Patil |
| Designation |
Post Graduate Student |
| Affiliation |
KLE VK Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences,
JNMC Campus, Nehru Nagar,
Belagavi-590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845585416 |
| Fax |
|
| Email |
aishwaryaarunpatil@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institue of Dental Sciences, Nehru Nagar, Belagavi |
|
|
Primary Sponsor
|
| Name |
Dr Aishwarya Arunkumar Patil |
| Address |
Department of Pediatric and Preventive Dentistry,
KAHERs KLE Vishwanath Katti Institute of Dental Sciences,
JNMC Campus, Nehru Nagar,
Belagavi-590010 |
| 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 Aishwarya Patil |
KLE VK Institute of Dental Sciences, Belagavi |
Department of Pediatric and Preventive Dentistry, Department No. 6, 1st Floor, KAHERs KLE Vishwanath Katti Institute of Dental Sciences,
JNMC Campus, Nehru Nagar,
Belagavi-590010
Belgaum
KARNATAKA |
9845585416
aishwaryaarunpatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
Evaluation of effectiveness of carbide burs for caries excavation will be done for 1 hour until entire caries excavation is completed in primary molars among children |
| Intervention |
Ceramic bur |
Evaluation of effectiveness of ceramic burs for caries excavation will be done for 1 hour until entire caries excavation is completed in primary molars among children |
| Intervention |
Polymer bur |
Evaluation of effectiveness of polymer burs for caries excavation will be done for 1 hour until entire caries excavation is completed in primary molars among children |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy children of age 4-8 years.
2. Mandibular primary molars which require class I restorations.
3. Caries involving dentin clinically and radiographically.
4. Carious tooth without any history of spontaneous pain. |
|
| ExclusionCriteria |
| Details |
1. Presence of any clinical/radiographic sign and symptom of pulpal and soft tissue pathology.
2. Grossly decayed teeth.
3. Children with negative (-) and definitely negative (--) behavior according to Frankl’s behavior rating scale.
4. Presence of developmental defects in primary molar.
5. Children with systemic conditions or special health care needs.
6. Children and/or Parents who are unwilling to participate in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time taken for caries excavation using ceramic burs, polymer burs and carbide burs |
Baseline and Post caries excavation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Caries removal efficacy score for caries excavation using ceramic burs, polymer burs & carbide burs |
Baseline & Post caries excavation |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| Date of Study Completion (India) |
31/12/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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
Modification(s)
|
The Principal Investigator will perform the procedure under
Standard Operating Protocols. The procedure will be carried out in 45 min for
each patient in all the three groups. Patients allocated to Group I will be
treated using Ceramic Bur, Group II using Polymer Bur and Group III will
be treated using Carbide Bur. The selected child will be made to sit
comfortably on the dental chair, the procedure will be completely explained to
the parent as well as the child by the Principal Investigator (PI). A case
history will be recorded for the present study so as to have a systematic and
methodological recording of all the observations and information. After
recording the preliminary information, clinical examination will be carried out
on a dental chair under standard operating protocol. The Principal
Investigator (PI) will assess the time taken by the caries excavating burs for
caries removal. A trained pediatric dentist will assess caries removal
efficacy of the burs using caries detecting dye and caries removal scoring
criteria. If caries is detected by the dye on the prepared cavity,
the caries will be excavated. Additional time taken by the bur for
caries excavation will be noted if caries is detected after the application of
caries detecting dye. Post caries excavation cavity will be restored using
Glass Ionomer restorative material. |