Dental CariesNCT03598972
the Effect of Prenatal Vitamins on the Tooth Structure
An observational study of Dental Caries, run by Cairo University.
Trial summary
the effect of mother prenatal care on the teeth of the newborn children, if it affect the tooth structure or not Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- intervention
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2021to 15 Jul 2021
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy children within the normal period of teeth shedding
Who may be able to join
None listed.
Who cannot join
- teeth extracted due to caries or trauma teeth with hereditary anomalies ex: hypoplasia
About this study
Official title: the Effect of Prenatal Vitamins on the Children Teeth: Elementary Analysis
the effect of mother prenatal care on the teeth of the newborn children, if it affect the tooth structure or not
Read the detailed description
teeth lost due to normal shedding will be collected,it will be classified into mother that take pregnancy vitamins and mother that doesn't take pregnancy vitamins, the female will be from the same population and from the same city to make sure that the environmental condition are almost the same .teeth will be subjected to elementary analysis to determine the different ratio of different component and if there is any change between the two group
- Conditions
- Dental Caries
- Being tested
- intervention
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interventionOther
elementary analysis
| Study group | Role | What they receive |
|---|---|---|
| control | teeth of children of non vitamin taking mother Receives: Other: intervention | |
| intervention | children teeth of vitamin taking mother Receives: Other: intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
the different teeth minerals and component
analysis of exofilated teeth mineral ratio
Measured: 3months
Secondary outcomes (1)
caries index of chlidren
dmf index for every patient to count the total missed and decayed teeth
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start15 Jun 2021 (estimated)
- Primary completion15 Jul 2021 (estimated)
- Study completion15 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina mounir elkady, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598972
- Sponsor's protocol ID
- 57890
- Status last verified
- Mar 2020
- First submitted
- 16 Jul 2018
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effect of Prenatal Vitamins on the Children Teeth: Elementary Analysis
- ClinicalTrials.gov ID
- NCT03598972
- Acronym / sponsor ID
- 57890
- Conditions
- Dental Caries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Jun 2021 (estimated)
- Primary completion
- 15 Jul 2021 (estimated)
- Study completion
- 15 Jul 2021 (estimated)
- First posted
- 26 Jul 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.
the effect of mother prenatal care on the teeth of the newborn children, if it affect the tooth structure or not
Detailed description
teeth lost due to normal shedding will be collected,it will be classified into mother that take pregnancy vitamins and mother that doesn't take pregnancy vitamins, the female will be from the same population and from the same city to make sure that the environmental condition are almost the same .teeth will be subjected to elementary analysis to determine the different ratio of different component and if there is any change between the two group
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | – | Other: interventionteeth of children of non vitamin taking mother |
| intervention | – | Other: interventionchildren teeth of vitamin taking mother |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy children within the normal period of teeth shedding
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- teeth extracted due to caries or trauma teeth with hereditary anomalies ex: hypoplasia
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 |
|---|---|---|
| interventionelementary analysis | Other | control, intervention |
Primary outcome
the different teeth minerals and component
Time frame: 3months
analysis of exofilated teeth mineral ratio
1 secondary outcome
caries index of chlidren
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Dental Caries, 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 0 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 1 Apr 2020. 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?
the different teeth minerals and component (time frame: 3months). 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 1 Apr 2020.