Dental PlaqueNCT05304247
Prevalence and Risk Factors of Black Tooth Stains
An observational study of Dental Plaque, run by Mennatallah Hesham Elsayed Mohamed Ali.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- questionnaire and clinical examination
- How many people
- 320 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 May 2023
- 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 5 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A Group of Egyptian Preschool Children
Who may be able to join
- • 3-5 years old preschool children
- Children with primary dentition
Who cannot join
- Children whose parents refuse signing informed consent
Trial locations and contacts
No sites are listed yet.
randa Y abdel gawad, PHD contact
About this study
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.
To assess the prevalence of black tooth stains and their relation with caries experience in the primary dentition of 3-5-year-old children.
Read the 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.
- Conditions
- Dental Plaque
- Being tested
- questionnaire and clinical examination
- Keywords
- black stains
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire and clinical examinationOther
Prevalence and Risk Factors of Black Tooth Stains and Their Relation With Caries Experience in Primary Teeth of A Group of Preschool Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of black tooth stains
measurement method : clinical examination used to asses the prevalence of black stains . unit of measurement : binary ( yes , no ) .
Measured: base line
Secondary outcomes (2)
Risk factors of black tooth stains
measurement method : questionnaire used to asses the risk factors of black stains . unit of measurement : binary questions ( yes , no ) .
Measured: base line
caries experience
measurement method : dmf caries index used to asses the caries experience ,unit of measurement : scores .
Measured: base line
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Cross-sectional
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mennatallah Hesham Elsayed Mohamed Ali
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mennatallah Hesham Elsayed Mohamed Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304247
- Sponsor's protocol ID
- prevalence of BS
- Status last verified
- Jun 2022
- First submitted
- 12 Feb 2022
- Last updated
- 30 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32643037Franca-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.
PubMed 22488298Asokan 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.
PubMed 33753668Fernando Pessoa, U. (n.d.). Blanche Delcourt Chromogenic bacteria in the oral cavity and social impact in pediatric dentistry-A Literature Review
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.
PubMed 29120125
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05304247
- Acronym / sponsor ID
- prevalence of BS
- Conditions
- Dental Plaque
- Keywords
- black stains
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Mennatallah Hesham Elsayed Mohamed AliUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 31 Mar 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.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A Group of Egyptian Preschool Children
Key inclusion criteria (2 listed)
- • 3-5 years old preschool children
Key exclusion criteria (1 listed)
- Children whose parents refuse signing informed 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 |
|---|---|---|
| questionnaire and clinical examinationPrevalence and Risk Factors of Black Tooth Stains and Their Relation With Caries Experience in Primary Teeth of A Group of Preschool Children | Other | – |
Primary outcome
Prevalence of black tooth stains
Time frame: base line
measurement method : clinical examination used to asses the prevalence of black stains . unit of measurement : binary ( yes , no ) .
2 secondary outcomes
Risk factors of black tooth stains
Time frame: base line
caries experience
Time frame: base line
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2022.
- Background: PubMed 32643037Elelmi 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.
- Background: PubMed 22488298Franca-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.
- Background: PubMed 33753668Asokan 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.
- BackgroundFernando Pessoa, U. (n.d.). Blanche Delcourt Chromogenic bacteria in the oral cavity and social impact in pediatric dentistry-A Literature Review
- Background: PubMed 29120125Prskalo 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.
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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.
randa Y abdel gawad, PHD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Plaque, run by Mennatallah Hesham Elsayed Mohamed Ali.
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 1 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: status not confirmed, as of the sponsor's last update on 30 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact menna H ali (01225030867, mennatallah.hesham@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of black tooth stains (time frame: base line). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05304247, which also lists 5 linked publications.
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 30 Jun 2022.