Measurement of Mandibular Radio Morphometric Indices in E... | NCT03714035

Studies
Measurement of Mandibular Radio Morphometric Indices in Egyptian Population at Different Ages

NCT03714035

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Oct 22, 2018Actual

Enrollment

360Estimated

Phase

Not provided

Conditions

Mandibular Fractures

Interventions

no intervention

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

ID	Type	Description	Link
FDCU	Other Identifier	faculty of dentistry

Status Module

Record Verification Date

Oct 2018

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

Oct 30, 2018Estimated

Primary Completion Date

Jun 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Oct 18, 2018

First Submission Date that Met QC Criteria

Oct 19, 2018

First Posted Date

Oct 22, 2018Actual

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

Oct 19, 2018

Last Update Posted Date

Oct 22, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hanaa Sayed Mansy, demonstrator at faculty of dentistry cairo university, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

this study aims to correlate mandibular indices and different ages in a sample of Egyptian population.

Detailed Description

this study is an observational cross sectional study to correlate the mandibular radiomorphometric indices with age in sample of egyptian population using CBCT scans at faculty of dentistry cairo university

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

360Estimated

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
panoramic mandibular index	ratio between the thickness of the mandible at the mental foramen area and the distance measured from the inferior border of the mental foramen to the inferior border of the mandible. The value of 0.3 will be considered as normal value while the lower value indicate abnormal inferior border thickness	2018-2020

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Egyptian individuals with different ages starting from 10 - 70 years.
Females and males of the mentioned ages.

Exclusion Criteria:

Individuals younger than 10 and older than 70 years old.
Presence of a large pathological lesions in the mandible at the areas intended for measurements.
Patients of severely resorbed mandibular bone.
Patients with any bony deformity at the inferior border of the mandible.
Patients with fracture at the areas to be examined.
Patients with evident radiographic asymmetry.
Patients with evident radiographic abnormality suggestive of systemic disease predisposing to osteoporosis.
Patients with current postoperative surgical defect healing at the areas intended for measurements.
Patients with mandibular reconstruction

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

a sample of egyptian population

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
hana mansy, PHD	Contact	01003266948		hana.manssy@dentistry.cu.edu.eg
yara helaly, PHD	Contact	01001929701		yara.helaly@dentistry.cu.edu.eg

Overall Officials

Name	Affiliation	Role
Dentistry Cairo, Univeristy	Ethical committee faculty if dentustry cairo unveristry	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of dentistry cairo univeristy		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008337	Mandibular Fractures

Ancestor Terms

ID	Term
D007572	Jaw Fractures
D008446	Maxillofacial Injuries
D005151	Facial Injuries
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided