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VITAMIN D GENE: Vit D Receptor Gene Polymorphism

Sponsor
Ajman University (Other)
Overall Status
Completed
CT.gov ID
NCT05931705
Collaborator
(none)
376
Enrollment
1
Location
12.5
Actual Duration (Months)
30.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire

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 Design

Study Type:
Observational
Actual Enrollment :
376 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Vit D Receptor Gene Polymorphism and Its Possible Association With Prevalence of Dental Caries
Actual Study Start Date :
Mar 1, 2022
Actual Primary Completion Date :
Jan 10, 2023
Actual Study Completion Date :
Mar 15, 2023

Arms and Interventions

Arm Intervention/Treatment
High risk

Other: questionnaire
questionnaire

Outcome Measures

Primary Outcome Measures

  1. DMFT scores [six months]

    Scores are 1 for dental caries present and 0 for dental caries absent

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Healthy individuals free of associated systemic conditions

  • Individuals not under any nutritional supplementation

Exclusion Criteria:

  • lactating mothers

  • smokers

  • menopausal women

Contacts and Locations

Locations

Site City State Country Postal Code
1 AB shetty Institute of dental sciences Mangaluru Karnataka India 009716

Sponsors and Collaborators

  • Ajman University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
sudhir rama varma, Clinical Assistant Professor, Ajman University
ClinicalTrials.gov Identifier:
NCT05931705
Other Study ID Numbers:
  • (NU/CEC/2020/0339).
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by sudhir rama varma, Clinical Assistant Professor, Ajman University
Vitamin D Gene Polymorphism
Dental Caries
Cathelicidins
Additional relevant MeSH terms:
Dental Caries

Study Results

No Results Posted as of Jul 5, 2023