NCT06197880

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2024

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 9, 2024

Status Verified

December 1, 2023

Enrollment Period

1.5 years

First QC Date

December 26, 2023

Last Update Submit

December 26, 2023

Conditions

Airway

Keywords

en-masse retraction airway morphology CBCT

Outcome Measures

Primary Outcomes (1)

  • assess the changes in the airway morphology

    measure the airway volume before and after treatment

    6 months

Study Arms (1)

Bimaxillary protrusion

EXPERIMENTAL

En masse retraction

Other: Anterior teeth retraction

Interventions

Anterior teeth retractionOTHER

En masse retraction of the upper and lower anterior segments using maximum anchorage

Bimaxillary protrusion

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Beni Suef University

Banī Suwayf, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 20677956BACKGROUND

  • 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.

    PMID: 21793712BACKGROUND

  • Chen Y, Hong L, Wang CL, Zhang SJ, Cao C, Wei F, Lv T, Zhang F, Liu DX. Effect of large incisor retraction on upper airway morphology in adult bimaxillary protrusion patients. Angle Orthod. 2012 Nov;82(6):964-70. doi: 10.2319/110211-675.1. Epub 2012 Mar 30.

    PMID: 22462464BACKGROUND

Study Officials

  • Rehab Khalil

    Faculty of Dentistry Beni Suef University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single-arm clinical trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Orthodontics

Study Record Dates

First Submitted

December 26, 2023

First Posted

January 9, 2024

Study Start

July 20, 2022

Primary Completion

January 15, 2024

Study Completion

February 1, 2024

Last Updated

January 9, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)