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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05304247
Other study ID # prevalence of BS
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date May 31, 2023

Study information

Verified date June 2022
Source Cairo University
Contact menna H ali
Phone 01225030867
Email mennatallah.hesham@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 320
Est. completion date May 31, 2023
Est. primary completion date April 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 5 Years
Eligibility Inclusion Criteria: - • 3-5 years old preschool children - Children with primary dentition Exclusion Criteria: • Children whose parents refuse signing informed consent

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mennatallah Hesham Elsayed Mohamed Ali

References & Publications (5)

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. Review. — View Citation

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. — View Citation

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

França-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. — View Citation

Prskalo K, Klaric Sever E, Aleric I, Antonic Jelic T, Žaja 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. — View Citation

Outcome

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