FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 samplingInclusion/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.

 
Close