Determination of Teeth Size in a Group of Egyptian Childr... | NCT03234829

Studies
Determination of Teeth Size in a Group of Egyptian Children. A Cross Sectional Study

NCT03234829

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 1, 2017Actual

Enrollment

270Estimated

Phase

Not provided

Conditions

Teeth Size in a Group of Egyptian Children

Interventions

Not provided

Countries

Egypt

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

Jul 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2017Estimated

Primary Completion Date

Dec 2017Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Jul 27, 2017

First Submission Date that Met QC Criteria

Jul 27, 2017

First Posted Date

Jul 31, 2017Actual

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 28, 2017

Last Update Posted Date

Aug 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Determination of The Combined Mesio-Distal Widths of The Permanent Mandibular Incisors and That of The Maxillary and Mandibular Canines and Premolars in a Group of Egyptian Children in Rural Areas of Sohag Governorate: A Cross Sectional Study

Detailed Description

Study Settings:

Students will be randomly selected from preparatory schools in rural areas of Sohag governorate, seated in the school lap or an empty classroom.
Clinical examination will be made in the daylight using disposable diagnostic sets (mirror, and explorer). No diagnostic radiographs will be taken.
Operator: Master degree's student in Pediatric Dentistry and Dental Public Health.
Full mouth alginate impression will be taken and study models will be poured within one hour with hard dental stone for each subject.
Mesio-distal widths of both maxillary and mandibular permanent incisors, canines, first and second premolars will be measured from the study models using digital caliper according to the method described by(Moorrees & Reed, 1964) by measuring the greatest distance between the contact points on the proximal surfaces holding the caliper parallel to both occlusal and vestibular surfaces of the tooth.

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

270Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The combined mesio-distal widths of the permanent mandibular incisors, the maxillary canines, mandibular canines and premolars.	using Digital Caliper the data will be recorded in Millimeter.	one weak

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are apparently medically free from any systemic disease.
Patients aged between 12-15 years.
Full set of fully erupted permanent dentition from left 1st permanent molar to right 1st permanent molar.
No apparent orthodontics problem.

Exclusion Criteria:

Patients with craniofacial developmental abnormality.
Any sensitivity or adverse reactions to any of used materials.
Patients who refused to participate in the study.
Teeth with severe malalignment or rotation.
Teeth with any inaccuracy caused by impression taking, pouring impressions with dental stone or any damage or breakage while the dental casts had been stored.
Teethwith notable wear, proximal decay, restorations, enamel hypoplasia or crown fracture.
Teeth with developmental anomalies such as microdont teeth, teeth with extra cusps or big talon cusps, or peg or conical shaped teeth.
Supernumerary or supplemental teeth (if present)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Students will be randomly selected using simple random sampling from preparatory schools in rural areas of Sohag governorate.

Sampling Method

Probability Sample

Name	Affiliation	Role
Eman S Elmasry, ass. prof	Cairo University	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Oral and Dental Medicine Faculity		Cairo		11553	Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27810383	Background	Shaweesh AI. Mesiodistal and faciolingual diameters of the permanent teeth in a Jordanian population. Arch Oral Biol. 2017 Jan;73:253-258. doi: 10.1016/j.archoralbio.2016.10.026. Epub 2016 Oct 26.