Prevalence and Risk Factors of Black Tooth Stains

June 26, 2022 updated by: Mennatallah Hesham Elsayed Mohamed Ali

Prevalence and Risk Factors of Black Tooth Stains and Their Relation With Caries Experience in Primary Teeth of A Group of Preschool Children: A Cross-Sectional Study.

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

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Tooth discoloration is frequently seen by dental practitioners and is considered an aesthetic problem. There are two types of teeth discoloration; intrinsic discoloration which is related to intrinsic factors such as congenital and inherited conditions and extrinsic discoloration which occurs due to the formation of pigments on the enamel surface (Prskalo et al., 2017).

Black stain is a specific type of external tooth discoloration. It is clinically diagnosed as dark dots on the gingival third of the tooth that may coalesce and form a complete dark line following gingival contour or can also impregnate pits, fissures, and grooves (França-Pinto et al., 2012).

Black stains are a common finding in children and are seen equally in both genders (Zyła et al., 2015). When children's smiles do not fit the esthetic criteria, it can have negative social and psychological consequences causing embarrassing situations for the child, including school bullying. Their guardians may also be affected as people could judge it as bad oral health and question the care given to these children .(Fernando Pessoa, n.d.)

The etiology of black stains is multifactorial . Chromogenic anaerobic bacteria have been considered one of the etiological factors by their production of hydrogen sulfide that interacts with iron present in saliva and forms insoluble ferric sulfate which is the main component of these pigments (Elelmi et al., 2021).

Rational:

Although black stains have been considered a protective factor against caries, they are considered a common aesthetic problem. According to the systematic review of Asokan et al., 2020, there is conflicting data on the relation between tooth stains and dental caries as some studies showed a positive association between black stains and caries and other studies showed a negative association between them, and therefore, further studies are needed to completely understand the nature, risk factors of black stains and their relation with caries experience.

Study Type

Observational

Enrollment (Anticipated)

320

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: randa Y abdel gawad, PHD
  • Phone Number: 01222272010

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

3 years to 5 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

A Group of Egyptian Preschool Children

Description

Inclusion Criteria:

  • • 3-5 years old preschool children

    • Children with primary dentition

Exclusion Criteria:

• Children whose parents refuse signing informed consent

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of black tooth stains
Time Frame: base line
measurement method : clinical examination used to asses the prevalence of black stains . unit of measurement : binary ( yes , no ) .
base line

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factors of black tooth stains
Time Frame: base line
measurement method : questionnaire used to asses the risk factors of black stains . unit of measurement : binary questions ( yes , no ) .
base line
caries experience
Time Frame: base line
measurement method : dmf caries index used to asses the caries experience ,unit of measurement : scores .
base line

Collaborators and Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Anticipated)

January 1, 2023

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

February 12, 2022

First Submitted That Met QC Criteria

March 22, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • prevalence of BS

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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