| 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
|
|
|
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
|
|
|
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
|
|
|
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. |