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CTRI Number  CTRI/2024/05/068033 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 28/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Exploring Nutritional Status and Its Link to Malocclusion and Dental Caries in Rural and Urban Children aged 6 -14 years. 
Scientific Title of Study   Assessment of Nutritional Status and its Relationship with Malocclusion and Dental caries in Rural and Urban Children Aged between 6-14 years. 
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 KONDREDDY PRABHANJANA SREE 
Designation  Post Graduate Student 
Affiliation  Sri Sai College of Dental Surgery, Vikarabad 
Address  Department of Pediatric and Preventive Dentistry, Room no - 9, 1-2-64/1 and 2, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad Hyderabad TELANGANA 501102 INDIA

Hyderabad
TELANGANA
501102
India 
Phone  9052441200  
Fax    
Email  prabha14sree@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SILLA SWARNA SWATHI 
Designation  PROFESSOR 
Affiliation  Sri Sai College of Dental Surgery, Vikarabad 
Address  Department of Pediatric and Preventive Dentistry, Room no - 9, 1-2-64/1 and 2, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad Hyderabad TELANGANA 501102 INDIA

Hyderabad
TELANGANA
501102
India 
Phone  9790215500  
Fax    
Email  swathi.swarna18@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr SILLA SWARNA SWATHI 
Designation  PROFESSOR 
Affiliation  Sri Sai College of Dental Surgery, Vikarabad 
Address  Department of Pediatric and Preventive Dentistry, Room no - 9 1-2-64/1 and 2, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad Hyderabad TELANGANA 501102 INDIA

Hyderabad
TELANGANA
501102
India 
Phone  9790215500  
Fax    
Email  swathi.swarna18@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr KONDREDDY PRABHANJANA SREE 
Address  Sri Sai College Of Dental Surgery Department of Pediatric and Preventive Dentistry, Room no - 9 1-2-64/1 and 2, Kothrepally, Opposite Shiv Sagar Lake, Vikarabad Hyderabad TELANGANA 501102 INDIA 
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 PRABHANJANA SREE  Sri Sai College of Dental Surgery, Vikarabad  Department of Pediatric and Preventive Dentistry, Room no - 9, 1-2-64/1 and 2, Kothrepally, opposite Shiv Sagar Lake, Vikarabad Hyderabad TELANGANA 501102 INDIA
Hyderabad
TELANGANA 
9052441200

prabha14sree@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE 2023-2024  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Systemically Healthy Children aged between 6 to 14 years of age 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children aged between 6-14 years
Children whose parents gave consent
 
 
ExclusionCriteria 
Details  Children with physical or mental disabilities
Children with systemic illness and craniofacial anomalies
Children undergoing orthodontic treatment or who underwent orthodontic treatment
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The present study is designed to assess the nutritional status and its correlation with malocclusion and dental caries in rural and urban children.  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="600"
Sample Size from India="600" 
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)   01/08/2024 
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="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  

Nutritional status plays a crucial role in the development and maintenance of oral health, with significant implications for the prevalence of malocclusion and dental caries in children. Adequate nutrition supports proper growth and development of craniofacial structures, influencing factors such as tooth eruption, jaw alignment, and facial symmetry. Malnutrition, characterized by deficiencies in essential nutrients, can disrupt these processes, leading to abnormalities in dental occlusion and alignment, contributing to malocclusion.Moreover, dietary habits directly impact the risk of dental caries development. High intake of fermentable carbohydrates, such as sugars and refined starches, promotes the growth of cariogenic bacteria in dental plaque, leading to acid production and subsequent enamel demineralization. Conversely, a diet rich in essential nutrients like calcium, phosphorus, and vitamins supports optimal enamel formation and remineralization, reducing the susceptibility to dental caries.The correlation between nutritional status, malocclusion, and dental caries underscores the importance of holistic approaches to oral health promotion. By promoting balanced nutrition and healthy dietary habits, oral health professionals can mitigate the risk factors associated with malocclusion and dental caries, ultimately improving the oral health and overall well-being of children.

 
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