NCT05304247

Brief Summary

To assess the prevalence of black tooth stains and their relation with caries experience in the primary dentition of 3-5-year-old children.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

February 12, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 31, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

4 months

First QC Date

February 12, 2022

Last Update Submit

June 26, 2022

Conditions

Keywords

black stains

Outcome Measures

Primary Outcomes (1)

  • Prevalence of black tooth stains

    measurement method : clinical examination used to asses the prevalence of black stains . unit of measurement : binary ( yes , no ) .

    base line

Secondary Outcomes (2)

  • Risk factors of black tooth stains

    base line

  • caries experience

    base line

Interventions

Prevalence and Risk Factors of Black Tooth Stains and Their Relation With Caries Experience in Primary Teeth of A Group of Preschool Children

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

A Group of Egyptian Preschool Children

You may qualify if:

  • 3-5 years old preschool children
  • Children with primary dentition

You may not qualify if:

  • Children whose parents refuse signing informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Elelmi Y, Mabrouk R, Masmoudi F, Baaziz A, Maatouk F, Ghedira H. Black stain and dental caries in primary teeth of Tunisian preschool children. Eur Arch Paediatr Dent. 2021 Apr;22(2):235-240. doi: 10.1007/s40368-020-00549-3. Epub 2020 Jul 8.

    PMID: 32643037BACKGROUND
  • Franca-Pinto CC, Cenci MS, Correa MB, Romano AR, Peres MA, Peres KG, Matijasevich A, Santos IS, Barros AJ, Demarco FF. Association between black stains and dental caries in primary teeth: findings from a Brazilian population-based birth cohort. Caries Res. 2012;46(2):170-6. doi: 10.1159/000337280. Epub 2012 Apr 6.

    PMID: 22488298BACKGROUND
  • Asokan S, Varshini KR, Geetha Priya PR, Vijayasankari V. Association between black stains and early childhood caries - A systematic review. Indian J Dent Res. 2020 Nov-Dec;31(6):957-962. doi: 10.4103/ijdr.IJDR_327_20.

    PMID: 33753668BACKGROUND
  • Fernando Pessoa, U. (n.d.). Blanche Delcourt Chromogenic bacteria in the oral cavity and social impact in pediatric dentistry-A Literature Review

    BACKGROUND
  • Prskalo K, Klaric Sever E, Aleric I, Antonic Jelic T, Zaja I. Risk Factors Associated with Black Tooth Stain. Acta Clin Croat. 2017 Mar;56(1):28-35. doi: 10.20471/acc.2017.56.01.05.

    PMID: 29120125BACKGROUND

MeSH Terms

Conditions

Dental Plaque

Interventions

Surveys and QuestionnairesRestraint, Physical

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

randa Y abdel gawad, PHD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 12, 2022

First Posted

March 31, 2022

Study Start

January 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

June 30, 2022

Record last verified: 2022-06