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NCT04900077
Effect of Carriere® Motion™ Appliance on Airway Dimensions
NA trial testing Carriere® Motion™ Appliance in Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions in 42 participants. Completed in 19 January 2022.
20 June 2021
Quick facts
| Lead sponsor | King Abdulaziz University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 13 June 2019 |
| Primary completion | 20 June 2021 |
| Estimated completion | 19 January 2022 |
| Sites | 1 location across Saudi Arabia |
Drugs / interventions tested
- Carriere® Motion™ Appliance
Conditions studied
- Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions — all drugs for Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions →
- Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements — all drugs for Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements →
Sponsor
King Abdulaziz University
Who can join
Adults 12 to 20, any sex, with Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions or Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04900077
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04900077 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by King Abdulaziz University
- Last refreshed: 5 April 2022
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