Effect of Carriere® Motion™ Appliance on Airway Dimensions

NCT04900077 | Completed DMC FDA Device

• 2 other identifiers: 022-01-191532-165-1440
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions; Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements

Outcome Measures

Primary Outcomes (1)

• cephalometric pharyngeal airway changes (linear cephalometric measurements in mm)

  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 Outcomes (1)

• skeletal and dental cephalometric changes (linear and angular cephalometric measurements)

  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.

Study Arms (2)

treatment group

EXPERIMENTAL

treated by Carriere® Motion™ Appliance

Device: Carriere® Motion™ Appliance

control group

NO INTERVENTION

no treatment

Interventions

Carriere® Motion™ Appliance DEVICE

class II malocclusion corrector

treatment group

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King Abdulaziz University

Jeddah, Saudi Arabia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Consultant of Orthodontics

Study Record Dates

• First Submitted: May 5, 2021
• First Posted: May 25, 2021
• Study Start: June 13, 2019
• Primary Completion: June 20, 2021
• Study Completion: January 19, 2022
• Last Updated: April 5, 2022

Record last verified: 2022-03

Locations

SA (1)