Effect of Carriere® Motion™ Appliance on Airway Dimensions

March 24, 2022 updated by: Slaha Aljohani, King Abdulaziz University

Short Term Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions: A Prospective Controlled Clinical Study

Objectives: to evaluate the effect of treatment with Carriere® Motion™ Appliance on pharyngeal airway, skeletal and dental dimensions using lateral cephalometric radiographs and to compare these changes with a control group.

Materials and Methods: a prospective controlled clinical study on 17 patients treated at King Abdulaziz university dental hospital, Jeddah, Saudi Arabia with a mean age of 15.25 ± 2.49 years with class II molar relationship (treatment group). They were treated with Carriere® Motion™ Appliance and initial and post treatment lateral cephalograms were taken to assess the effect of the appliance on the pharyngeal airway dimensions, skeletal and dental measurements. A matched sample of 18 untreated patients (with a mean age of 14.44 ± 2.25 years) acted as a control group. Independent sample T-test and paired T-tests were conducted. The significance level was set at P< 0.05.

Results: when the cephalometric changes associated with the treatment by Carriere® Motion™ Appliance were compared to the changes in the untreated control group, no significant differences were found between the groups in regard to the pharyngeal airway and the skeletal dimensions. The only significant difference between the two groups was in the proclination and the protrusion of the lower incisors. The treatment group showed significantly increased lower incisors proclination and protrusion (L1 to mand plane°= 3.38±2.6, L1-Apo= 0.99±1.45) compared to the control group (L1 to mand plane°=0.49±2.81, L1-Apo=0.39±1.86) (P<0.05).

Conclusion: treatment with Carriere® Motion™ Appliance does not have a significant effect on pharyngeal airway and skeletal dimensions. However, it significantly increases the lower incisors proclination and protrusion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • King Abdulaziz University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Class II molar relationship.
  • Full set of teeth from 1st molar to 1st molar.
  • Age: between 12 and 20 years.

Exclusion Criteria:

  • Craniofacial deformities.
  • Previous orthodontic treatment.
  • History of respiratory illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: treatment group
treated by Carriere® Motion™ Appliance
Device: Carriere® Motion™ Appliance
class II malocclusion corrector
No Intervention: control group
no treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cephalometric pharyngeal airway changes (linear cephalometric measurements in mm)
Time Frame: For the treatment group: when class I molar relationship achieved. For the control group: not more than 18 months interval between the two lateral cephalograms.
For the treatment group: when class I molar relationship achieved. For the control group: not more than 18 months interval between the two lateral cephalograms.

Secondary Outcome Measures

Outcome Measure
Time Frame
skeletal and dental cephalometric changes (linear and angular cephalometric measurements)
Time Frame: For the treatment group: when class I molar relationship achieved. For the control group: not more than 18 months interval between the two lateral cephalograms.
For the treatment group: when class I molar relationship achieved. For the control group: not more than 18 months interval between the two lateral cephalograms.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 13, 2019

Primary Completion (Actual)

June 20, 2021

Study Completion (Actual)

January 19, 2022

Study Registration Dates

First Submitted

May 5, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 25, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 24, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 022-01-19
  • 1532-165-1440 (Other Grant/Funding Number: King Abdulaziz University Research Grants)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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