Prevalence of Facial Asymmetry Among Orthodontic Patients | NCT04635319

Studies
Prevalence of Facial Asymmetry Among Orthodontic Patients

NCT04635319

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Nov 19, 2020Actual

Enrollment

132Estimated

Phase

Not provided

Conditions

Facial Asymmetry

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2020Estimated

Primary Completion Date

May 20, 2021Estimated

Completion Date

Dec 20, 2021Estimated

First Submitted Date

Nov 13, 2020

First Submission Date that Met QC Criteria

Nov 13, 2020

First Posted Date

Nov 19, 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

Nov 13, 2020

Last Update Posted Date

Nov 19, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed AbdAllah Zaki Elsayed, Mohamed Abdallah Zaki Elsayed, Cairo UniversityPrincipal Investigator

Lead Sponsor

Cairo UniversityOTHER

Collaborators

Not provided

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

To estimate the prevalence of facial asymmetry

Detailed Description

The objectives of the present study are:

To estimate the prevalence of facial asymmetry among Egyptian population, according to type, sex, and age.
To provide an insight into the key aspects to be taken into consideration while accomplishing an accurate diagnosis and formulation of rational integrated orthodontic-surgical treatment plan that considers correction of all aspects of the asymmetry.

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

132Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
18-40 years old of both sexes		patient from 18 to 40 years old seeking orthodontic treatment

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Type of facial asymmetry	chin deviation,deviation of the nasal pyramid and degree of occlusal plane cant and the relation between each type and existing malocclusion.	Just before the orthodontic treatment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

between 18-40 years old of both sexes who asked for orthodontic treatment

Exclusion Criteria:

• No previous orthodontic treatment.
- photographs of poor quality.
- Any hereditary diseases or syndromes such as Down's syndrome or cleidocranial dysostosis.
- Any disease of the jaw that might have affected the normal growth of permanent dentition.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Only patient's age between 18-40 years old of both sexes who asked for orthodontic treatment will be included in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Abdallah, Master	Contact	1068489227	0020	mohamed_zaki@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of dentistry Cairo university	Recruiting	Cairo			Egypt

Condition Browse Module

MeSH Terms

ID	Term
D005146	Facial Asymmetry

Ancestor Terms

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided