NCT05249491

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 20, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
Last Updated

February 21, 2022

Status Verified

December 1, 2018

Enrollment Period

5 months

First QC Date

December 20, 2021

Last Update Submit

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

Diagnostic Test: Microbiological evaluation of dental plaques with children with or without black tooth stain

Group 2

Children without black tooth stain

Diagnostic Test: Microbiological evaluation of dental plaques with children with or without black tooth stain

Interventions

Evaluation of the etiological factors of black tooth stain according to the questionnaire

Also known as: Etiological factors of black tooth stain
Group 1Group 2

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (1)

Ege University

Izmir, 35040, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Dental plaque samples were collected from cases with black tooth stain and without black stain for microbiological procedures.

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Dilşah Çoğulu, Prof. Dr.

    Ege University, Izmir, Turkey

    STUDY DIRECTOR

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

Locations