Airway Morphology After En-masse Retraction in Bimaxillar... | NCT06197880

Studies
Airway Morphology After En-masse Retraction in Bimaxillary Protrusion Patients

NCT06197880

Sponsor

Beni-Suef University

Status

Unknown status

Last Update Posted

Jan 9, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Airway

Interventions

Anterior teeth retraction

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 20, 2022Actual

Primary Completion Date

Jan 15, 2024Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Dec 26, 2023

First Submission Date that Met QC Criteria

Dec 26, 2023

First Posted Date

Jan 9, 2024Actual

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

Dec 26, 2023

Last Update Posted Date

Jan 9, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rehab Abd El Razek Abd El Aziz Khalil, Lecturer of Orthodontics, Beni-Suef UniversityPrincipal Investigator

Lead Sponsor

Beni-Suef 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

This study aims to three-dimensionally assess the changes in the airway morphology after anterior segment retraction using maximum anchorage.

Detailed Description

Participants were recruited from the Faculty of Dentistry, Beni-Suef University. All subjects were informed of the treatment procedures and signed a consent form.

Methodology:

The patients were treated by using fixed appliance and extraction of four first premolars. Maximum anchorage was obtained by using miniscrews that were inserted between the maxillary first molars and second premolars. En masse retraction of the upper and lower anterior segments was carried out by using NiTi closed coil springs.

Cone beam computed tomography (CBCT) will be obtained before (T0) and after en masse retraction (T1). CBCT will be used for three-dimensional evaluation of the changes of the airway morphology after en masse retraction of the upper and lower anterior segments with maximum anchorage.

The results will be obtained and statistically evaluated.

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bimaxillary protrusion	Experimental	En masse retraction	Other: Anterior teeth retraction

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anterior teeth retraction	Other	En masse retraction of the upper and lower anterior segments using maximum anchorage	Bimaxillary protrusion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
assess the changes in the airway morphology	measure the airway volume before and after treatment	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Class I bimaxillary protrusion requiring extraction of four first premolars and en masse retraction of the anterior segments.
Age: 18 - 35 years old.
Fair oral hygiene.

Exclusion Criteria:

Active periodontal disease.
Systemic diseases or medications that alter bone metabolism.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rehab Khalil	Faculty of Dentistry Beni Suef University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry Beni Suef University		Banī Suwayf			Egypt

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20677956	Background	Valiathan M, El H, Hans MG, Palomo MJ. Effects of extraction versus non-extraction treatment on oropharyngeal airway volume. Angle Orthod. 2010 Nov;80(6):1068-74. doi: 10.2319/010810-19.1.
21793712	Background	Wang Q, Jia P, Anderson NK, Wang L, Lin J. Changes of pharyngeal airway size and hyoid bone position following orthodontic treatment of Class I bimaxillary protrusion. Angle Orthod. 2012 Jan;82(1):115-21. doi: 10.2319/011011-13.1. Epub 2011 Jul 27.