| CTRI Number |
CTRI/2024/04/065092 [Registered on: 02/04/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of occlusal force distribution using T-scanâ„¢ among children aged 5-10 years undergoing stainless steel crown placement by Conventional and Halls technique. |
|
Scientific Title of Study
|
Comparative evaluation of occlusal force distribution among children aged 5-10 years undergoing stainless steel crown placement by Conventional and Halls technique using T-scanâ„¢: A randomised 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 |
Krishna Kajave |
| Designation |
Post graduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC
Campus, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9663751557 |
| Fax |
|
| Email |
krishnakajave1923@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Niraj Gokhale |
| Designation |
Professor |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC
Campus, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9535551937 |
| Fax |
|
| Email |
neerajpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Krishna Kajave |
| Designation |
Post graduate student |
| Affiliation |
KAHERs KLE VK Institute of Dental Sciences |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, JNMC
Campus, Nehru Nagar, Belagavi, Karnataka.
Belgaum
KARNATAKA
590010
India |
| Phone |
9663751557 |
| Fax |
|
| Email |
neerajpedo@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHERS KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi, Karnataka 590010. |
|
|
Primary Sponsor
|
| Name |
Krishna Kajave |
| Address |
Department of Pediatric and Preventive Dentistry, KAHERs KLE VK Institute of Dental Sciences, Belagavi
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Krishna Kajave |
KAHERs KLE VK Institute of Dental Sciences, JNMC Campus, Nehru Nagar, Belagavi. |
Department no.06,
Department of Pediatric and
Preventive Dentistry.
Belgaum
KARNATAKA |
9663751557
krishnakajave1923@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RESEARCH AND ETHICS COMMITTE, KLE VK Institute of Dental Sciences, Belagavi, Karnataka. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K041||Necrosis of pulp, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional technique |
Evaluation of occlusal force distribution among children aged 5-10 years undergoing stainless steel crown placement by Conventional technique using T-scanâ„¢ pre-operatively, post-operatively and at 1 month follow up. |
| Intervention |
Halls technique |
Evaluation of occlusal force distribution among children aged 5-10 years undergoing stainless steel crown placement by Halls technique using T-scanâ„¢ pre-operatively, post-operatively and at 1 month follow up. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral primary mandibular molars those who have undergone pulpotomy or pulpectomy.
Unilateral primary mandibular molars having multi-surface caries involving enamel, dentin and not approaching pulp.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Occlusal bite force and occlusal force distribution |
Occlusal bite force and occlusal force distribution evaluation pre-operatively, post-operatively and at 1 month follow up. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
24/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
24/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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
|
Children who fulfill the inclusion criteria will be made to snit comfortably on the dental chair and the procedure to be done will be explained to the patient as well as the parent. Detailed case history will be recorded and written consent will be taken from the parents. Pre-operative recording of occlusal bite parameters will be done using alu wax and T-scan, following this crown placement procedure will be carried out depending on the group in which the participant is allotted. Post-operative and 1 month follow up recording of occlusal bite parameters will be done using alu wax and T-scan. |