Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth StainsNCT03563469
Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth
An observational study of Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth Stains, run by Cairo University.
Trial summary
Black stains (BS) are type of extrinsic discoloration of the tooth. It's characterized as dark lines or an incomplete coalescence of dark dots found mostly on cervical third of the crown. Most studies worldwide found that children with the black stained teeth have low caries prevalence. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth Stains
- What is being tested?
- Salivary bacterial and pH level
- Type of treatment
- Pill or oral medicine
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Sep 2019
- How long will I take part?
- 6 Months
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Egyptian children 4-6 years old with black stained teeth.
Who may be able to join
- Patients with black stained teeth who were reported to outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University ranging in age between 4-6 years.
- With primary dentition.
- Both sexes will be included.
- Cooperative children.
Who cannot join
- Having oral disease (such as peridotites, salivary gland disorder, and oral mucosal disease).
- Having autoimmune disease.
- Receiving any antibiotic treatment in the past three months.
- Parents refuse to sign the consent
About this study
Official title: Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth: A Cross Sectional Study
Black stains (BS) are type of extrinsic discoloration of the tooth. It's characterized as dark lines or an incomplete coalescence of dark dots found mostly on cervical third of the crown. Most studies worldwide found that children with the black stained teeth have low caries prevalence. A study on Brazilian population also suggested that black stains might be protective factor against development of dental caries. A study reported that chromogenic bacteria were proposed as etiological factor in production of black stains.The most common microbiological composition of BS was found to be Actinomycetes. Dental examination and saliva samples collection will be done for black stained teeth children of outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. This research adopts null hypothesis; it assumes that there is no effect on dental caries experience in children with black stained teeth.
- Being tested
- Salivary bacterial and pH level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salivary bacterial and pH levelOther
Also called Dental caries experience using dmft caries index
- Saliva sample will be collection ask the patient to stop eating and drinking for one hour before collecting the sample,(2) Give the patient distilled water and ask them to rinse their mouth well for 1 min,five minutes after this oral rinse, ask the patient to spit into 50ml sterile tube, collect 5ml of saliva and return to the laboratory within an hour.
- The dental caries of all patients will also be recorded using dental mirror and explorer. The caries experience will be recorded in diagnostic chart using the World Health Organization (WHO) criteria for deciduous teeth and dmft caries index.
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary bacterial level
salivary sample collection by passive drooling
Measured: 6 months
Secondary outcomes (2)
Dental caries experience
The dental caries of all patients will also be recorded using dental mirror and explorer. The caries experience will be recorded in diagnostic chart using the World Health Organization (WHO) criteria for deciduous teeth and dmft caries index
Measured: 6 months
Salivary pH level
salivary sample collection and measured by the pH meter
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 posted20 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth StainsStudies of the same condition, open and under way.
- More trials run by Cairo 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Nassef William Samuel, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03563469
- Sponsor's protocol ID
- CEBD-CU-2015-02-26
- Status last verified
- Jun 2018
- First submitted
- 9 Jun 2018
- Last updated
- 20 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Salivary Bacterial Level and Dental Caries Experience in a Group of Egyptian Children With Black Stained Teeth: A Cross Sectional Study
- ClinicalTrials.gov ID
- NCT03563469
- Acronym / sponsor ID
- CEBD-CU-2015-02-26
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 20 Jun 2018 (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.
Black stains (BS) are type of extrinsic discoloration of the tooth. It's characterized as dark lines or an incomplete coalescence of dark dots found mostly on cervical third of the crown. Most studies worldwide found that children with the black stained teeth have low caries prevalence. A study on Brazilian population also suggested that black stains might be protective factor against development of dental caries. A study reported that chromogenic bacteria were proposed as etiological factor in production of black stains.The most common microbiological composition of BS was found to be Actinomycetes. Dental examination and saliva samples collection will be done for black stained teeth children of outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University. This research adopts null hypothesis; it assumes that there is no effect on dental caries experience in children with black stained teeth.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Egyptian children 4-6 years old with black stained teeth.
Key inclusion criteria (4 listed)
- Patients with black stained teeth who were reported to outpatient clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University ranging in age between 4-6 years.
- With primary dentition.
- Both sexes will be included.
- Cooperative children.
Key exclusion criteria (4 listed)
- Having oral disease (such as peridotites, salivary gland disorder, and oral mucosal disease).
- Having autoimmune disease.
- Receiving any antibiotic treatment in the past three months.
- 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 |
|---|---|---|
| Salivary bacterial and pH levelAlso: Dental caries experience using dmft caries index1. Saliva sample will be collection ask the patient to stop eating and drinking for one hour before collecting the sample,(2) Give the patient distilled water and ask them to rinse their mouth well for 1 min,five minutes after this oral rinse, ask the patient to spit into 50ml sterile tube, collect 5ml of saliva and return to the laboratory within an hour. 2. The dental caries of all patients will also be recorded using dental mirror and explorer. The caries experience will be recorded in diagnostic chart using the World Health Organization (WHO) criteria for deciduous teeth and dmft caries index. | Other | – |
Primary outcome
Salivary bacterial level
Time frame: 6 months
salivary sample collection by passive drooling
2 secondary outcomes
Dental caries experience
Time frame: 6 months
Salivary pH level
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Black Stain Dental, Dental Black Stain, Black Stain*, Black Stains, Tooth Stains, run by Cairo University.
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 4 inclusion and 4 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 20 Jun 2018. 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?
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 20 Jun 2018.