Eruption Statues of Primary Teeth in LBW ChildrenNCT04343846
Eruption Status of Primary Teeth in Low Birth Weight Children in Comparison to Normal Birth Weight Childern
An observational study of Eruption Statues of Primary Teeth in LBW Children, run by Cairo University.
Trial summary
determine the status of eruption of primary teeth and physical growth in children aged from 6 to 36 months with low birth weight in comparison to normal birth weight Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Eruption Statues of Primary Teeth in LBW Children
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2020to 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: healthy children aged from 6 months to 36 months
Who may be able to join
- Healthy children.
- Children aged from 6 to 36 month.
Who cannot join
- Refusal of participation from the parents.
- Medically compromised children.
- Major illness.
- The child had special needs.
- Any systemic disease.
- Any congenital deformity that may affect teeth eruption.
About this study
Official title: Eruption Status of Primary Teeth and BMI in Low Birth Weight Children in Comparison to Normal Birth Weight Children
determine the status of eruption of primary teeth and physical growth in children aged from 6 to 36 months with low birth weight in comparison to normal birth weight
Read the detailed description
Timing of eruption of primary teeth is an urgent question for every mother especially in low birth weight children. Although, the timing of eruption of primary teeth and their sequence of eruption shown to be under the genetic control , pre-natal maternal conditions, early childhood metabolic and nutritional factors along with socioeconomic states have been associated with the timing of eruption of primary teeth.
Many factors may affect the timing of eruption. Literature showed that factors like gender, race and physical growth may influence emergence of tooth in child mouth but there is scarce information on Egyptian children .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group A | low birth weight children | |
| group B | normal birth weight children |
What is being measured
The primary outcome is the main question the study is designed to answer.
status of eruption of primary teeth
clinical examination
Measured: 1 year
Secondary outcomes (1)
child physical growth
weight in kilograms height in centimeter weight and height will be combined to report BMI in kg/m^2
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2020
- Study start1 Aug 2020 (estimated)
- Primary completion1 Jun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Eruption Statues of Primary Teeth in LBW ChildrenStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hadeer Magdy Sayed Mohamed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04343846
- Sponsor's protocol ID
- primary teeth eruption
- Status last verified
- Jan 2020
- First submitted
- 19 Feb 2020
- Last updated
- 15 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shaweesh AI, Al-Batayneh OB. Association of weight and height with timing of deciduous tooth emergence. Arch Oral Biol. 2018 Mar;87:168-171. doi: 10.1016/j.archoralbio.2017.12.030. Epub 2017 Dec 29.
PubMed 29304424Soliman NL, El-Zainy MA, Hassan RM, Aly RM. Relationship of deciduous teeth emergence with physical growth. Indian J Dent Res. 2012 Mar-Apr;23(2):236-40. doi: 10.4103/0970-9290.100433.
PubMed 22945716
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eruption Status of Primary Teeth and BMI in Low Birth Weight Children in Comparison to Normal Birth Weight Children
- ClinicalTrials.gov ID
- NCT04343846
- Acronym / sponsor ID
- primary teeth eruption
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 13 Apr 2020 (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.
determine the status of eruption of primary teeth and physical growth in children aged from 6 to 36 months with low birth weight in comparison to normal birth weight
Detailed description
Timing of eruption of primary teeth is an urgent question for every mother especially in low birth weight children. Although, the timing of eruption of primary teeth and their sequence of eruption shown to be under the genetic control , pre-natal maternal conditions, early childhood metabolic and nutritional factors along with socioeconomic states have been associated with the timing of eruption of primary teeth.
Many factors may affect the timing of eruption. Literature showed that factors like gender, race and physical growth may influence emergence of tooth in child mouth but there is scarce information on Egyptian children .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | – | –low birth weight children |
| group B | – | –normal birth weight children |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- healthy children aged from 6 months to 36 months
Key inclusion criteria (2 listed)
- Healthy children.
- Children aged from 6 to 36 month.
Key exclusion criteria (6 listed)
- Refusal of participation from the parents.
- Medically compromised children.
- Major illness.
- The child had special needs.
- Any systemic disease.
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
status of eruption of primary teeth
Time frame: 1 year
clinical examination
1 secondary outcome
child physical growth
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 29304424Shaweesh AI, Al-Batayneh OB. Association of weight and height with timing of deciduous tooth emergence. Arch Oral Biol. 2018 Mar;87:168-171. doi: 10.1016/j.archoralbio.2017.12.030. Epub 2017 Dec 29.
- Background: PubMed 22945716Soliman NL, El-Zainy MA, Hassan RM, Aly RM. Relationship of deciduous teeth emergence with physical growth. Indian J Dent Res. 2012 Mar-Apr;23(2):236-40. doi: 10.4103/0970-9290.100433.
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 Eruption Statues of Primary Teeth in LBW Children, 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 2 inclusion and 6 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 15 Jul 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?
status of eruption of primary teeth (time frame: 1 year). 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 NCT04343846, which also lists 2 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 15 Jul 2020.