| CTRI Number |
CTRI/2025/04/085024 [Registered on: 17/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Exploring How Poor Nutrition Affects Teeth Alignment in the Tribal Population of Melghat Region |
|
Scientific Title of Study
|
Association of Nutritional Deficiency with Malocclusion in Tribal Population of Melghat Region |
| 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 Bhakti Kalbande |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Room no.110, Department of Orthodontics and Dentofacial Orthopedics,Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
7972150022 |
| Fax |
|
| Email |
kalbandebhakti17@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bhakti Kalbande |
| Designation |
Professor and Head of Department |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Room no 110, Department of Orthodontics and Dentofacial Orthopedics, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
7972150022 |
| Fax |
|
| Email |
dr_usha_shenoy@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhakti Kalbande |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Room no. 110, Department of Orthodontics and Dentofacial Orthopedics,Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur
Nagpur MAHARASHTRA 440019 India |
| Phone |
7972150022 |
| Fax |
|
| Email |
dr_usha_shenoy@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur, India 440019 |
|
|
Primary Sponsor
|
| Name |
Dr Bhakti Kalbande |
| Address |
Room no.110, Department of Orthodontics and Dentofacial Orthopedics, Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Nagpur, India 440019 |
| 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 Bhakti Kalbande |
Ranjeet Deshmukh Dental College and Research Centre |
Roon no. 110, department of orthodontics and dentofacial orthopedics, RDDC & RC, DIGDOH HILLS, NAGPUR Nagpur MAHARASHTRA |
7972150022
kalbandebhakti17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VSPM RDDC NAGPUR |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
nutritional deficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: Participants aged between 15-18 years, as this is a critical period for assessing both malocclusion and nutritional status.
2. Tribal Population: Participants must belong to a recognized tribal community within the selected study area.
3. Informed Consent: Written informed consent from guardians
4. Residency: Participants must be permanent residents of the study area to ensure consistent dietary and environmental factors.
5. Health Condition: Participants must not have any severe systemic diseases or conditions that may interfere with the study’s focus on nutrition and oral health (e.g., chronic diseases that affect bone health, such as osteoporosis).
|
|
| ExclusionCriteria |
| Details |
1.Age Outside the Target Range: Individuals younger than 15 or older than 18 years will be excluded, as they fall outside the scope of the study.
2. Non-Tribal Population: Participants who do not belong to the tribal community being studied will be excluded.
3. Severe Oral Pathologies: Participants with severe oral health conditions that could confound the results (eg, severe periodontal disease, systemic conditions affecting the oral cavity, or those undergoing active orthodontic treatments) will be excluded.
4. Recent Nutritional Interventions: Participants who have undergone any recent medical or nutritional treatments (eg, supplements for malnutrition) within the last 6 months will be excluded, as they could introduce bias in assessing the relationship between nutrition and malocclusion.
5. Non-Cooperation: Participants who are unwilling to cooperate or do not complete the study protocol (eg, missing dental exams or failing to provide accurate dietary information) will be excluded from the final analysis. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the specific nutritional deficiencies (e.g., calcium, vitamin D, iron, b12, protein)
To evaluate the prevalence of malocclusion in tribal populations.
To assess the relationship between specific nutritional deficiencies and malocclusion.
|
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To raise awareness about the importance of proper nutrition in promoting oral health & preventing malocclusion in tribal populations.
To assess the overall nutritional status & its potential impact on oral health outcomes in tribal communities.
|
12 months |
|
|
Target Sample Size
|
Total Sample Size="185" Sample Size from India="185"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/05/2025 |
| 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
|
This study explores the association between nutritional deficiencies and malocclusion in tribal populations, with a specific focus on adolescents aged 15–18 years from the Melghat region. Malocclusion, a common dental issue, is especially prevalent in underserved tribal areas due to poor nutrition, limited healthcare access, and lack of awareness. The introduction outlines how deficiencies in key nutrients like calcium, vitamin D, iron, and B12 negatively affect dental and skeletal development, contributing to various forms of malocclusion such as crowding and bite issues. The primary research question investigates the relationship between these deficiencies and malocclusion prevalence. The literature review presents studies that have linked poor dietary intake and limited healthcare to higher malocclusion rates in tribal populations. However, most research to date lacks empirical data, focuses on general populations, or fails to explore specific nutrient-related correlations. This highlights a research gap that this study aims to fill.The aim of the study is to assess the relationship between specific nutritional deficiencies and malocclusion in Melghat’s tribal adolescents. Objectives include evaluating the prevalence of both nutritional deficiencies and malocclusion, as well as raising awareness and understanding their connection.Methodology, Design Cross-sectional study in collaboration with the Public Health Centre in Tembursonda, Sample 185 tribal adolescents 15–18 years, selected through convenience sampling, Inclusion/Exclusion Criteria Focuses on tribal status, age, residency, and health status to ensure reliable results.Nutritional Assessment (via blood tests): Iron, Calcium,Vitamin B12,Vitamin D. Malocclusion Assessment Based on Angle’s classification Class I, II, III and Dental Aesthetic Index.Trained dentists will assess additional traits like crowding, spacing, and bite issues. |