Vit D Receptor Gene Polymorphism

Vitamin D Status Clinical Trial

— VITAMIN D GENE  

Official title:

Vit D Receptor Gene Polymorphism and Its Possible Association With Prevalence of Dental Caries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05931705
• Other study ID #: (NU/CEC/2020/0339).
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: March 15, 2023

Study information

• Verified date: July 2023
• Source: Ajman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present cross-sectional observational study was conducted after the university ethical committee approved the research (NU/CEC/2020/0339). This study included 376 adults in the age group of 18-40Yrs. The patient information sheet briefed the study details and usage of salivary samples. Informed consent was obtained from participants. Healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded

Description:

The present cross-sectional observational study was conducted after the university ethical committee approved the research (NU/CEC/2020/0339). This study included 376 adults in the age group of 18-40Yrs. The patient information sheet briefed the study details and usage of salivary samples. Informed consent was obtained from participants. Healthy individuals free of associated systemic conditions, individuals not under any nutritional supplementation were included in the study, and lactating mothers, smokers, and menopausal women were excluded.

Further, the subjects were divided into active and caries-free based on caries experience. Two indexing methods were utilized to record the decay status, i.e., Decay, Missing, filled (DMFT) and Pulpal, Ulcerative, Fistula (PUFA) scores. Caries active group was further divided into a High-risk group (DMFT=< 10), Moderate risk (DMFT= 4-9), and Low risk (DMFT=1-3).

Questionnaire: Baseline information was gathered, including specifics on age, sex, height, weight, dietary preferences (non-veg/veg), and dental hygiene practices.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: March 15, 2023
• Est. primary completion date: January 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Healthy individuals free of associated systemic conditions

• Individuals not under any nutritional supplementation

Exclusion Criteria:

• lactating mothers

• smokers

• menopausal women

Related Conditions & MeSH terms

• Dental Caries
• Vitamin D Status

Intervention

Other:
• questionnaire
questionnaire

Locations

Country	Name	City	State
India	AB shetty Institute of dental sciences	Mangaluru	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Ajman University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DMFT scores	Scores are 1 for dental caries present and 0 for dental caries absent	six months