| CTRI Number |
CTRI/2024/12/078057 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the risk and prevalence of malocclusion in primary dentition by using Baby-ROMA Index in 3–6-year-old children of Rajnandgaon District, Chhattisgarh: A Cross-Sectional Study |
|
Scientific Title of Study
|
Evaluation of risk of malocclusion in primary dentition by using Baby-ROMA (Risk Of Malocclusion Assessment Index) in 3–6-year-old children of Rajnandgaon District, Chhattisgarh: A Cross Sectional 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 Sanchita Dhote |
| Designation |
post graduate student |
| Affiliation |
Chhattisgarh Dental College and Research Institute, sundra, Rajnandgaon-491441 |
| Address |
Room no. 04, Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College and Research Institute,Sundra,Rajnandgaon
Room no. 04, Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College and Research Institute,Sundra,Rajnandgaon
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
09766510239 |
| Fax |
|
| Email |
sanchitadhote7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ANUSHKA DEOGHARE |
| Designation |
professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute, sundra, Rajnandgaon-491441 |
| Address |
Room no. 04, Department of Pedodontics and Preventive Dentistry,Chhattisgarh Dental College and Research Institute,Sundra,Rajnandgaon
Room no. 04, Department of Pedodontics and Preventive Dentistry, CHHATTISGARH DENTAL COLLEGE AND RESEARCH INSTITUTE,SUNDRA,RAJNANDGAON
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9893781119 |
| Fax |
|
| Email |
dranushkadeoghare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANUSHKA DEOGHARE |
| Designation |
professor |
| Affiliation |
Chhattisgarh Dental College and Research Institute, sundra, Rajnandgaon-491441 |
| Address |
Room no. 04, Department of Pedodontics and Preventive Dentistry,Chhattisgarh Dental College and Research Institute, Sundra, Rajnandgaon
Room no.04, Department of Pedodontics and Preventive Dentistry,CHHATTISGARH DENTAL COLLEGE AND RESEARCH INSTITUTE,SUNDRA,RAJNANDGAON
Rajnandgaon
CHHATTISGARH
491441
India |
| Phone |
9893781119 |
| Fax |
|
| Email |
dranushkadeoghare@gmail.com |
|
|
Source of Monetary or Material Support
|
| self, Department of Pedodontics and Preventive Dentistry, Chhattisgarh Dental College and Research Institute, Rajnandgaon, Chhattisgarh,India-491441 |
|
|
Primary Sponsor
|
| Name |
Dr Sanchita Dhote |
| Address |
Chhattisgarh Dental College and Research Institute, sundra, Rajnandgaon-491441 |
| Type of Sponsor |
Other [dental 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 Sanchita Dhote |
Chhattisgarh Dental College and Institute |
Room no. 04,Department of Pedodontics and Preventive Dentistry,Chhattisgarh Dental College and Research Institute,Sundra,Rajnandgaon-491441
Rajnandgaon
CHHATTISGARH |
09766510239
sanchitadhote7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Chhattisgarh Dental College and Research Institute,Rajnandgaon. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
childrens with primary dentition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group of 3-6 year.
2. Children with primary dentition.
3. Children who’s parents are ready to participate in the study.
4. Children who are residents of Chhattisgarh. |
|
| ExclusionCriteria |
| Details |
Non cooperative children.
Children with ongoing orthodontic treatment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of malocclusion by using baby ROMA Index in 3–6-year-old children of Rajnandgaon District, Chhattisgarh. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess preventive orthodontic treatment needs in 3–6-year-old children in Rajnandgaon District, Chhattisgarh. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="600"
Sample Size from India="600"
Final Enrollment numbers achieved (Total)= "600"
Final Enrollment numbers achieved (India)="600" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/12/2024 |
| Date of Study Completion (India) |
15/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
15/01/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
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)
|
Summary Orthodontic therapies during primary dentition play a crucial role in promoting oral health and preventing more complex treatments in permanent dentition. The unique features of primary dentition lay the foundation for proper eruption and alignment of permanent teeth. Preventive orthodontic therapies aim to encourage physiological development and avoid the progression of malocclusions, while interceptive treatments restore normal occlusion when malocclusion occurs. Early orthodontic interventions are particularly beneficial for correcting skeletal malocclusions in young children, offering more stable outcomes, reduced need for permanent teeth extractions, lower costs, decreased enamel hypoplasia and periodontal diseases, and higher parental satisfaction. Early treatment is especially recommended for space discrepancies caused by premature loss of primary teeth or crowding. Orthodontic treatment need indices, like the Orthodontic Index (OI) and the Index of Preventive and Interceptive Orthodontic Treatment Need (IPION), have limitations in addressing skeletal and functional problems or assessing malocclusion prevalence. To address these gaps, the baby ROMA Index was developed to target primary dentition, focusing on early diagnosis and treatment of malocclusions. A study is planned to assess the prevalence of malocclusion and the need for preventive orthodontic treatment in 3–6-year-old children in Rajnandgaon district, Chhattisgarh, using the baby ROMA Index. Study Details: - Aim: Assess the risk of malocclusion in primary dentition using the baby ROMA Index.
- Objectives:
- Primary: Determine the prevalence of malocclusion in 3–6-year-old children.
- Secondary: Evaluate preventive orthodontic treatment needs.
- Sample Design: Multistage stratified random sampling.
- Sample Size: 600 children aged 3–6 years from pre-primary schools in Rajnandgaon district.
- Inclusion Criteria: Children aged 3–6 years with primary dentition, residents of Chhattisgarh, and parental consent.
- Exclusion Criteria: Non-cooperative children and those undergoing orthodontic treatment.
|