Prevalence of MLFA Types and MD in Egyptian Children With... | NCT04244903

Studies
Prevalence of MLFA Types and MD in Egyptian Children With Erupted Canines

NCT04244903

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Jun 2, 2022Actual

Enrollment

275Estimated

Phase

Not provided

Conditions

Destructive Attachment of Labial Frenum

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

Jun 2022

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

Jun 2022Estimated

Primary Completion Date

Jun 2022Estimated

Completion Date

Aug 2022Estimated

First Submitted Date

Jan 25, 2020

First Submission Date that Met QC Criteria

Jan 25, 2020

First Posted Date

Jan 28, 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

Jun 1, 2022

Last Update Posted Date

Jun 2, 2022Actual

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

Descriptive observational cross sectional study Outpatient at faculty of dentistry Cairo university pediatric dentistry department clinic with midline diastema and fully erupted canines will be examined and assess type of frenal attachment to see if correlation present or not

Detailed Description

Not provided

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

275Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Midline diastema	measuring diastema in millimeters using calibrated ruler	1 year

Secondary Outcomes

Measure	Description	Time Frame
Frenal attachment types	Direct visual method	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Systemically healthy children
Egyptian children with fully erupted canines
Patient presented for routine evaluation or treatment

Exclusion Criteria:

Children who exhibited congenital anomalies or orofacial defects
Children with previous trauma in frenal area which affect its morphology
Children have previous surgical intervention in labial frenum or in the maxillary anterior region.
Children have any syndromes or habits that affect the anterior maxillary region.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

13 Years

Standard Ages

Child

Study Population

This study will be conducted among Egyptian children with fully erupted canines, who regularly attend the outpatient clinic of pediatric dentistry department, Cairo University.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
33,saad ibn aby waqas street, faisal, giza	Contact	01014007249		Asmaa_saad@dentistry.cu.edu.eg
33,saad ibn aby waqas street, faisal, giza	Contact	01004541979		Wael.mustafa@dentistry.cu.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry Cairo University	Recruiting	Cairo	Giza Governorate		Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided