Vit D Receptor Gene Polymorphism (VITAMIN D GENE)

July 1, 2023 updated by: sudhir rama varma, Ajman University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

376

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Karnataka
      • Mangaluru, Karnataka, India, 009716
        • AB shetty Institute of dental sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population included participants with active dental caries and associated wasting disease of the teeth due to caries

Description

Inclusion Criteria:

  • Healthy individuals free of associated systemic conditions
  • Individuals not under any nutritional supplementation

Exclusion Criteria:

  • lactating mothers
  • smokers
  • menopausal women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
High risk
Other: questionnaire
questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DMFT scores
Time Frame: six months
Scores are 1 for dental caries present and 0 for dental caries absent
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ajman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

January 10, 2023

Study Completion (Actual)

March 15, 2023

Study Registration Dates

First Submitted

June 14, 2023

First Submitted That Met QC Criteria

July 1, 2023

First Posted (Actual)

July 5, 2023

Study Record Updates

Last Update Posted (Actual)

July 5, 2023

Last Update Submitted That Met QC Criteria

July 1, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (NU/CEC/2020/0339).

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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