NCT05931705

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

11 months

First QC Date

June 14, 2023

Last Update Submit

July 1, 2023

Conditions

Vitamin D Status

Keywords

Vitamin D Gene PolymorphismDental CariesCathelicidins

Outcome Measures

Primary Outcomes (1)

  • DMFT scores

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

    six months

Study Arms (1)

High risk

Other: questionnaire

Interventions

questionnaireOTHER

questionnaire

High risk

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • lactating mothers
  • smokers
  • menopausal women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AB shetty Institute of dental sciences

Mangaluru, Karnataka, 009716, India

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

June 14, 2023

First Posted

July 5, 2023

Study Start

March 1, 2022

Primary Completion

January 10, 2023

Study Completion

March 15, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

Results

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations

IN(1)