NCT05902611

Brief Summary

The aim of the current study will be to explore the relationship between body mass index, dental eruption and dental caries prevalence in school Children.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,224

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 21, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

June 15, 2023

Status Verified

June 1, 2023

Enrollment Period

2.2 years

First QC Date

June 3, 2023

Last Update Submit

June 10, 2023

Conditions

Body Mass IndexDental CariesEruption

Outcome Measures

Primary Outcomes (1)

  • Body Mass Index using this equation: weight in kilograms divided by the square of height in meters

    2 years

Interventions

BMI determination, Eruption Time Assessment, Caries AssessmentBEHAVIORAL

BMI determination, Eruption Time Assessment, Caries Assessment

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The aim of this study is to find out the relationship between body mass index, dental eruption and dental caries in children aged 6 to 9 years, based on the previous study by Anu 2020 (15) who reported a correlation of -0.08 between body mass index and eruption status of permanent mandibular molar; a total sample size of 1224 will be sufficient with power 80 % and 5% significant level. The sample size was calculated by PASS 2008.

You may qualify if:

  • Parents and patients, acceptance and cooperation.
  • children between 6 and 9 years of age.

You may not qualify if:

  • Uncooperative child.
  • Children with systemic disease that can affect their cooperation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AlAzhar university

Cairo, Egypt

RECRUITING

Related Publications (1)

  • Sanchez-Perez L, Irigoyen ME, Zepeda M. Dental caries, tooth eruption timing and obesity: a longitudinal study in a group of Mexican schoolchildren. Acta Odontol Scand. 2010 Jan;68(1):57-64. doi: 10.3109/00016350903449367.

    PMID: 19958253BACKGROUND

Related Links

MeSH Terms

Conditions

Dental CariesExanthema

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Alaa Nabil Abbas, PHD

    Al-Azhar University

    STUDY CHAIR

Central Study Contacts

Mohamed Ahmed Hammad, Master

CONTACT

201061413777sword_fish33@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

June 3, 2023

First Posted

June 15, 2023

Study Start

April 21, 2021

Primary Completion

June 21, 2023

Study Completion

September 21, 2023

Last Updated

June 15, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)