Prevalence and Risk Factors of Black Tooth Stains

Sponsor
Mennatallah Hesham Elsayed Mohamed Ali (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05304247
Collaborator
(none)
320
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionnaire and clinical examination

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 Design

Study Type:
Observational
Anticipated Enrollment :
320 participants
Observational Model:
Case-Crossover
Time Perspective:
Cross-Sectional
Official Title:
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.
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 31, 2023

Outcome Measures

Primary Outcome Measures

  1. Prevalence of black tooth stains [base line]

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

Secondary Outcome Measures

  1. Risk factors of black tooth stains [base line]

    measurement method : questionnaire used to asses the risk factors of black stains . unit of measurement : binary questions ( yes , no ) .

  2. caries experience [base line]

    measurement method : dmf caries index used to asses the caries experience ,unit of measurement : scores .

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Years to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • • 3-5 years old preschool children

  • Children with primary dentition

Exclusion Criteria:

• Children whose parents refuse signing informed consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mennatallah Hesham Elsayed Mohamed Ali

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mennatallah Hesham Elsayed Mohamed Ali, Principal investigator, Cairo University
ClinicalTrials.gov Identifier:
NCT05304247
Other Study ID Numbers:
  • prevalence of BS
First Posted:
Mar 31, 2022
Last Update Posted:
Jun 30, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mennatallah Hesham Elsayed Mohamed Ali, Principal investigator, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 30, 2022