EruptionNCT03054571
Correlation Between Somatic Growth and Number of Erupted Deciduous Teeth
An observational study of Eruption, run by Cairo University.
Trial summary
This investigation seeks to build upon existing evidence that a relationship exists between body mass and timing and the number of erupted teeth. Read more about this study
- Who is it for?
- Ages 5 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Eruption
- How many people
- 91 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Apr 2017
- 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 5 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects will be selected according to the following inclusion and exclusion criteria: 1. Inclusion criteria: 1. Healthy infants aged 5-36 months. 2. Absence of medical and congenital diseases. 3. Full term infants. 4. Residents of Cairo governorate. 2. Exclusion criteria: Presence of natal and neonatal teeth.
Who may be able to join
- Healthy infants aged 5-36 months. 2-Absence of medical and congenital diseases. 3-Full term infants. 4-Residents of Cairo governorate.
Who cannot join
- Presence of natal and neonatal teeth.
Trial locations and contacts
No sites are listed yet.
About this study
This investigation seeks to build upon existing evidence that a relationship exists between body mass and timing and the number of erupted teeth.
Read the detailed description
Alteration in the order of teeth eruption denotes a disorder in normal development of the teeth, rather than delayed or accelerated growth. The more time deviation of teeth eruption from normal, the more possible the presence of a problem in development of teeth. For these reasons having a non-invasive tool such as body mass index to determine if development will be slower than average, could be helpful to the practitioner.
- Conditions
- Eruption
- Medical subject headings
- Exanthema
What is being measured
The primary outcome is the main question the study is designed to answer.
number of erupted teeth
the number of erupted erupted teeth will be counted if any part of the tooth appeared
Measured: around 2 months
Secondary outcomes (1)
body mass index
the index will be counted through the equation
Measured: around 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study startFeb 2017 (estimated)
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EruptionStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abdallah Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054571
- Sponsor's protocol ID
- DAhmed
- Status last verified
- Feb 2017
- First submitted
- 11 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: publishing through an national journal
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Somatic Growth and Number of Erupted Deciduous Teeth
- ClinicalTrials.gov ID
- NCT03054571
- Acronym / sponsor ID
- DAhmed
- Conditions
- Eruption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 15 Feb 2017 (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.
This investigation seeks to build upon existing evidence that a relationship exists between body mass and timing and the number of erupted teeth.
Detailed description
Alteration in the order of teeth eruption denotes a disorder in normal development of the teeth, rather than delayed or accelerated growth. The more time deviation of teeth eruption from normal, the more possible the presence of a problem in development of teeth. For these reasons having a non-invasive tool such as body mass index to determine if development will be slower than average, could be helpful to the practitioner.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 5 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects will be selected according to the following inclusion and exclusion criteria: 1. Inclusion criteria: 1. Healthy infants aged 5-36 months. 2. Absence of medical and congenital diseases. 3. Full term infants. 4. Residents of Cairo governorate. 2. Exclusion criteria: Presence of natal and neonatal teeth.
Key inclusion criteria (1 listed)
- Healthy infants aged 5-36 months. 2-Absence of medical and congenital diseases. 3-Full term infants. 4-Residents of Cairo governorate.
Key exclusion criteria (1 listed)
- Presence of natal and neonatal teeth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of erupted teeth
Time frame: around 2 months
the number of erupted erupted teeth will be counted if any part of the tooth appeared
1 secondary outcome
body mass index
Time frame: around 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided. publishing through an national journal
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Eruption, 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 1 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 23 Feb 2017. 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 dina abdallah, beclore degree (0120155321, dina.abdullah@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of erupted teeth (time frame: around 2 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 23 Feb 2017.