Tooth DiscolorationNCT05249491
Etiology of Black Tooth Stain in Children
An observational study of Tooth Discoloration, run by Ege University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Tooth Discoloration
- What is being tested?
- Microbiological evaluation of dental plaques with children with or without black tooth stain
- How many people
- 88 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 10 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- Child
Study population: 44 children with black tooth stain and 44 children without black tooth stain with the age 3-12 years old.
Who may be able to join
- Cooperative children with or without black tooth stain.
- Children aged between 3-12 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Etiological Factors of Black Tooth Stain in Children
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.
Read the 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.
- Conditions
- Tooth Discoloration
- Being tested
- Microbiological evaluation of dental plaques with children with or without black tooth stain
- Medical subject headings
- Tooth Discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microbiological evaluation of dental plaques with children with or without black tooth stainDiagnostic test
Also called Etiological factors of black tooth stain
Evaluation of the etiological factors of black tooth stain according to the questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Children with black tooth stain Receives: Diagnostic Test: Microbiological evaluation of dental plaques with children with or without black tooth stain | |
| Group 2 | Children without black tooth stain Receives: Diagnostic Test: Microbiological evaluation of dental plaques with children with or without black tooth stain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary bacterial level
Sample collection from dental plaque
Measured: 6 months
Secondary outcomes (1)
Dental caries experience
The dental caries incidence of all patients were recorded according to the dfs, DMFS indices
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start10 Jan 2018
- Primary completion10 Jun 2018
- Study completion10 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth DiscolorationStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilsah Cogulu, Ege University
- Investigators
- Dilşah Çoğulu, Prof. Dr., Study director, Ege University, Izmir, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05249491
- Sponsor's protocol ID
- Ege U. Eth. Com.-17-4/18
- Status last verified
- Dec 2018
- First submitted
- 20 Dec 2021
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Etiological Factors of Black Tooth Stain in Children
- ClinicalTrials.gov ID
- NCT05249491
- Acronym / sponsor ID
- Ege U. Eth. Com.-17-4/18
- Conditions
- Tooth Discoloration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 10 Dec 2018 (actual)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: Microbiological evaluation of dental plaques with children with or without black tooth stainChildren with black tooth stain |
| Group 2 | – | Diagnostic Test: Microbiological evaluation of dental plaques with children with or without black tooth stainChildren without black tooth stain |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- 44 children with black tooth stain and 44 children without black tooth stain with the age 3-12 years old.
Key inclusion criteria (2 listed)
- Cooperative children with or without black tooth stain.
- Children aged between 3-12 years old.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microbiological evaluation of dental plaques with children with or without black tooth stainAlso: Etiological factors of black tooth stainEvaluation of the etiological factors of black tooth stain according to the questionnaire | Diagnostic test | Group 1, Group 2 |
Primary outcome
Salivary bacterial level
Time frame: 6 months
Sample collection from dental plaque
1 secondary outcome
Dental caries experience
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Tooth Discoloration
Not yet recruiting
Children Acceptance of AgNP Mouthwash Against Chlorhexidine 0.12% and Chlorhexidine .2% Mouthwashs
Teeth Staining, Numbness of the Tongue and Soft Tissue
Not yet recruiting
Comparative Evaluation of the Anti-Plaque and Anti-Gingivitis Effects of Nanobiofusion Gingival Gel (NBF), Placebo Gel, and Commercial Toothpaste
Gingivitis, Healthy Adult
Recruiting
Peroxide Versus Non-Peroxide In-Office Tooth Bleaching
Tooth Discoloration, Tooth Staining
Recruiting
A Study to Assess the Efficacy of an Experimental Mouthwash Used With a Marketed Whitening Toothpaste on Stain Build-up
Tooth Discoloration
Active, not recruitingObservational study
Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilşah Çoğulu, Prof. Dr. study director
Ege University, Izmir, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Discoloration, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary bacterial level (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.