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Effect of Carriere® Motion™ Appliance on Airway Dimensions

NCT04900077 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2022-04-05

No results posted yet for this study

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

Interventions

DEVICE

Carriere® Motion™ Appliance

class II malocclusion corrector

Sponsors & Collaborators

  • King Abdulaziz University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-13
Primary Completion
2021-06-20
Completion
2022-01-19
FDA Device
Yes

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04900077 on ClinicalTrials.gov