Evaluation Treatment Outcomes of Anterior Open Bite Treat... | NCT06147739

Studies
Evaluation Treatment Outcomes of Anterior Open Bite Treated by Temporary Anchorage Devices

NCT06147739

Sponsor

Faculty of Dental Medicine for Girls

Status

Unknown status

Last Update Posted

Nov 28, 2023Actual

Enrollment

10Estimated

Phase

Not Applicable

Conditions

Anterior Openbite Malocclusion

Interventions

Temporary Anchorage Devices

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

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

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

Aug 11, 2021Actual

Primary Completion Date

Dec 11, 2023Estimated

Completion Date

Dec 20, 2023Estimated

First Submitted Date

Nov 12, 2023

First Submission Date that Met QC Criteria

Nov 22, 2023

First Posted Date

Nov 28, 2023Actual

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 22, 2023

Last Update Posted Date

Nov 28, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Bayan Saaidi, Principal Investigator Dr. Baian Msaaid Saaidi, Faculty of Dental Medicine for GirlsPrincipal Investigator

Lead Sponsor

Faculty of Dental Medicine for GirlsOTHER_GOV

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

The present study will be performed to Evaluate the treatment outcome of anterior open bite by temporary anchorage device on buccal and palatal mini screws

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Name	Type	Description	Arm Group Labels	Other Names
Temporary Anchorage Devices	Other	intrusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
open bite closure	the change in amount of open bite detected by mm. which measured from the cast model and from cephalometric x ray.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients age range 13-18 years old.
Patients have anterior open bite.
Normal healthy patient.
Patient have healthy oral tissues.
Patient have class I or II jaw relationship.
Patient have complete set of permanent teeth except the wisdom tooth.

Exclusion Criteria:

Uncooperative patient and parents.
patient who had undergo previous orthodontic treatment.
Patient with class III jaw relationship.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

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