Clinical trial NCT05304247: Prevalence and Risk Factors of Black Tooth Stains
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Plaque
Keywords: black stains
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 320
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: A Group of Egyptian Preschool Children

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.

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.

Eligibility criteria: Inclusion Criteria:

* • 3-5 years old preschool children

  * Children with primary dentition

Exclusion Criteria:

• Children whose parents refuse signing informed consent

Primary outcomes:
measure: Prevalence of black tooth stains
timeFrame: base line
Secondary outcomes:
measure: Risk factors of black tooth stains
timeFrame: base line
measure: caries experience
timeFrame: base line
Other outcomes:
Locations:
Study officials:
References:
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.
citation: 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.
citation: 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.
citation: Fernando Pessoa, U. (n.d.). Blanche Delcourt Chromogenic bacteria in the oral cavity and social impact in pediatric dentistry-A Literature Review
citation: 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.