Etiology of Black Tooth Stain in Children
Evaluation of the Etiological Factors of Black Tooth Stain in Children
1 other identifier
observational
88
1 country
1
Brief Summary
The aim of the present study was to investigate the relationship between the presence of black tooth stain (BS) and dental caries incidence, dental plaque scores and to examine the colonization of Streptococcus mutans, Lactobacillus spp., Actinomyces spp. and Capnocytophaga spp. in dental plaque samples with or without BS. The socioeconomic status of the family, the oral hygiene and dietary habits of the children, medical and dental history of the children were also compared between two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedFirst Submitted
Initial submission to the registry
December 20, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2022
CompletedFebruary 21, 2022
December 1, 2018
5 months
December 20, 2021
February 10, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Salivary bacterial level
Sample collection from dental plaque
6 months
Secondary Outcomes (1)
Dental caries experience
6 months
Other Outcomes (1)
Etiological factors of black tooth stain
6 months
Study Arms (2)
Group 1
Children with black tooth stain
Group 2
Children without black tooth stain
Interventions
Evaluation of the etiological factors of black tooth stain according to the questionnaire
Eligibility Criteria
44 children with black tooth stain and 44 children without black tooth stain with the age 3-12 years old.
You may qualify if:
- Cooperative children with or without black tooth stain.
- Children aged between 3-12 years old.
You may not qualify if:
- Uncooperative children.
- Children who had taken antibiotic therapy within 3 months prior to the dental plaque sampling and children with any systemic disease were not included to the study.
- Children having oral disease (periodontitis, oral mucosal disease etc.)
- Children having autoimmune disease.
- Parents refuse to sign the consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ege Universitylead
Study Sites (1)
Ege University
Izmir, 35040, Turkey (Türkiye)
Biospecimen
Dental plaque samples were collected from cases with black tooth stain and without black stain for microbiological procedures.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dilşah Çoğulu, Prof. Dr.
Ege University, Izmir, Turkey
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
December 20, 2021
First Posted
February 21, 2022
Study Start
January 10, 2018
Primary Completion
June 10, 2018
Study Completion
December 10, 2018
Last Updated
February 21, 2022
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share