| CTRI Number |
CTRI/2024/06/068478 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparison of bite force and body mass index before and after the needful dental treatment in children with multiple carious teeth |
|
Scientific Title of Study
|
Evaluation and correlation of full mouth oral rehabilitation on bite force and body mass index in early childhood caries patients: An in vivo 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 Rutuja Patil |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Paediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
09284208872 |
| Fax |
|
| Email |
rutupatil4498@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Khubchandani |
| Designation |
Associate Professor |
| Affiliation |
Datta meghe institute of Higher Education and Research |
| Address |
Department of Paediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Sawangi meghe , Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9403227618 |
| Fax |
|
| Email |
monika.khubchandani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Khubchandani |
| Designation |
Associate Professor |
| Affiliation |
Datta meghe institute of Higher Education and Research |
| Address |
Department of Paediatric and Preventive Dentistry, Sharad Pawar Dental College and Hospital, Sawangi meghe , Wardha
MAHARASHTRA
442001
India |
| Phone |
9403227618 |
| Fax |
|
| Email |
monika.khubchandani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education |
| Address |
Sawangi Meghe, Wardha |
| Type of Sponsor |
Private medical college |
|
|
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 Rutuja Patil |
Datta Meghe Institute of Higher Education and Research |
Third Floor 302 Department of Paediatrics and Preventive Dentistry, Sharad Pawar Dental College and Hospital,Sawangi Meghe
Wardha
MAHARASHTRA |
09284208872
rutupatil4498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Datta Meghe Higher Education and Research |
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 |
| Intervention |
Full mouth rehabilitation |
Pulpectomy, pulpotomy, restorations, crown placements and needful treatment will be done |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
Age of the child should be within the range of 4-6 years.
Child with primary dentition
Co-operative child with Frankel behaviour rating scale, definitely positive and positive.
Child with at least two opposing molars.
Children with good psychological and physical health.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Children with special health care needs.
Children with developmental dental anomalies.
Children with temporomandibular joint disorders.
Children with malocclusions.
Children with parafunctional habits.
Children with traumatic injuries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The bite force after completing oral rehabilitation of early childhood caries will be more than the bite force before any needful dental treatment and same for the body mass index as post treatment masticatory efficiency will be increased |
At baseline, immediately after treatment, after 1 week, 3 weeks and 6 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
25/07/2024 |
| 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="2"
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
|
Introduction:
Early
childhood caries (ECC) is a common condition affecting children, affecting
their development of phonetics, eating, aesthetics, and permanent teeth. Full
mouth rehabilitation is crucial for addressing immediate dental consequences
and long-term oral health. Rehabilitating bite force can help detect
stomatognathic system diseases and understand mandibular movements. Untreated
dental caries can lead to malnutrition, linear growth failure, and negative BMI.
Need of the study:
Bite force assessment in the full
mouth rehabilitation of early childhood caries will help in measuring
functionality, monitoring stability, finding issues early, ensuring treatment
effectiveness, and advising any necessary adjustments for the child’s best
dental health and so as to improve postoperative quality of life.
Aim:
The purpose of this present study is to analyse the
probable effects of full mouth oral rehabilitation of early childhood caries (ECC)
on bite forces at their maximum extent and on body mass index (BMI) in young
paediatric patients with primary dentition.
Materials and Methods:
This in-vivo study
will be performed in the Hospital in the “Department of Paediatric and
Preventive Dentistry†at “Sharad Pawar Dental College and Hospitalâ€
Maharashtra, India. In which maximum bite
force in young children aged 4-6 years using a Portable BITE FORCE MEASUREMENT
DEVICE (BYTE) will be measured at the central incisors, right and left molar
regions. Anthropometric measurements of height and weight will be taken using
scales, a portable stadiometer, and a calibrated electronic device. The child’s
body mass index (BMI) will be determined by calculating weight and height using
a known formula. Participants will undergo bite force measurements
and BMI measurements before and after dental treatment, with the difference
analyzed statistically. Anthropometric measurements will be taken
post-treatment, and the results will be compared before and after the
treatment. |