- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249491
Etiology of Black Tooth Stain in Children
Evaluation of the Etiological Factors of Black Tooth Stain in Children
Study Overview
Status
Conditions
Detailed Description
A total of 1000 children aged 3-12 years who applied to the Department of Pedodontics, Faculty of Dentistry, Ege University for routine dental examination were enrolled the study. From these group, children with BS (n=44) were selected as the study group. With the same number of the study group, with the same age and same sex, children without BS (n=44) were categorized as the control group. The parents were interviewed based on a structured questionnaire including questions on the socioeconomic status of the family, the oral hygiene and dietary habits of the children, medical and dental history of the children. The presence and grading of BS, dental caries incidence and dental plaque index scores were recorded by the same pediatric dentist (G.İ.). Dental examinations of the children were conducted under natural light with the aid of a dental mirror and explorer. Dental caries scores were recorded according to WHO (World Health Organization) criteria using DMFT/DMFS (decay, missing, filled, tooth/surface in permanent teeth) and dmft/dmfs indices (decay, missing, filled, tooth/surface in primary teeth). All children were classified according to the DMFT/dmft scores; Group-1: caries active (dmft+DMFT≥1), Group-2: caries-free (dmft+DMFT=0). Dental plaque scores were recorded according to Silness & Löe index. The BS scores were classified according to Gasparetto et al. The plaque samples were dispersed in a vortex mixer to obtain a homogeneous suspension and cultivated on selective VCAT medium (Oxoid) for Capnocytophaga spp., mitis salivarius agar (Difco) with 15% sucrose (Difco) and 0.2 units/mL of bacitracin (Sigma, Sigma-Aldrich Co., St Louis, MO, USA) for S. mutans , MRS Agar was used for the isolation of lactobacilli spp. (ref) and Actinomyces Selective Agar was used for the isolation of Actinomyces spp.
All data were analyzed by SPPS 25.0 (SPSS Statistics for Windows, Armonk, NY: IBM Corp.). In the analysis of data, t test and Mann Whitney-U test were used for the comparison of the two groups. Categorical data were analyzed by Fisher's Exact Test and chi square test. For the significance level of the tests, p<0.05 and p<0.01 were accepted.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Izmir, Turkey, 35040
- Ege University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cooperative children with or without black tooth stain.
- Children aged between 3-12 years old.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Group 1
Children with black tooth stain
|
Evaluation of the etiological factors of black tooth stain according to the questionnaire
Other Names:
|
|
Group 2
Children without black tooth stain
|
Evaluation of the etiological factors of black tooth stain according to the questionnaire
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Salivary bacterial level
Time Frame: 6 months
|
Sample collection from dental plaque
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental caries experience
Time Frame: 6 months
|
The dental caries incidence of all patients were recorded according to the dfs, DMFS indices
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Etiological factors of black tooth stain
Time Frame: 6 months
|
The etiological factors of black tooth stain was determined according to the structured questionnaire
|
6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dilşah Çoğulu, Prof. Dr., Ege University, Izmir, Turkey
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ege U. Eth. Com.-17-4/18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tooth Discoloration
-
Al-Azhar UniversityNot yet recruiting
-
Cairo UniversityUnknownDiscoloration, Tooth
-
Cairo UniversityNot yet recruiting
-
Cairo UniversityNot yet recruiting
-
Cairo UniversityNot yet recruitingDiscoloration, Tooth | Abrasion
-
Cairo UniversityNot yet recruiting
-
Technische Universität DresdenCompletedDiscoloration of TeethGermany
-
Aristotle University Of ThessalonikiCompleted
-
Cairo UniversityChildren's Cancer Hospital Egypt 57357CompletedDiscoloration, Tooth | Secondary Caries | Fracture ToothEgypt
Clinical Trials on Microbiological evaluation of dental plaques with children with or without black tooth stain
-
University Hospital, MontpellierCompletedAttention Deficit Disorder | Emotional DysfunctionFrance
-
Damascus UniversityCompletedDental Plaque | Dental Care | Dental ProphylaxisSyrian Arab Republic
-
HaEmek Medical Center, IsraelCompletedGastrointestinal DiseasesIsrael
-
J.H. DeVriesRijnstate Hospital; Inreda Diabetic B.V.CompletedDiabetes Mellitus, Type 1Netherlands
-
Assistance Publique - Hôpitaux de ParisNot yet recruitingPancreatic Adenocarcinoma | Pancreatic Head CancerFrance
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV Infections | Opioid Use | Drug Use | Opioid-use DisorderUnited States
-
QuantumLeap Healthcare CollaborativeRecruitingBreast Cancer | Breast Neoplasms | Breast Tumors | HER2-positive Breast Cancer | Angiosarcoma | Locally Advanced Breast Cancer | HER2-negative Breast Cancer | TNBC - Triple-Negative Breast Cancer | Hormone Receptor Positive Tumor | Hormone Receptor Negative Tumor | Early-stage Breast CancerUnited States
-
Hospital Universitari de BellvitgeInstitut d'Investigació Biomèdica de Bellvitge; University of Barcelona; Hospital...Not yet recruitingObesity | Atypical Endometrial Hyperplasia | Endometrial Cancer | Endometrial Cancer Stage I | Obesity & Overweight | Endometrial Intraepithelial Neoplasia | Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I | BMI>40 | Obesity Grade III