Eruption Status of Primary Teeth in Low Birth Weight Chil... | NCT04343846

Studies
Eruption Status of Primary Teeth in Low Birth Weight Children in Comparison to Normal Birth Weight Childern

NCT04343846

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jul 15, 2020Actual

Enrollment

72Estimated

Phase

Not provided

Conditions

Eruption Statues of Primary Teeth in LBW Children

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2020Estimated

Primary Completion Date

Jun 1, 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Feb 19, 2020

First Submission Date that Met QC Criteria

Apr 9, 2020

First Posted Date

Apr 13, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2020

Last Update Posted Date

Jul 15, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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 .

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group A		low birth weight children
group B		normal birth weight children

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
status of eruption of primary teeth	clinical examination	1 year

Secondary Outcomes

Measure	Description	Time Frame
child physical growth	weight in kilograms height in centimeter weight and height will be combined to report BMI in kg/m^2	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy children.
Children aged from 6 to 36 month.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

healthy children aged from 6 months to 36 months

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29304424	Background	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.
22945716	Background	Soliman 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.