Effect of Carriere® Motion™ Appliance on Pharyngeal Airway DimensionsNCT04900077
Effect of Carriere® Motion™ Appliance on Airway Dimensions
A study testing Carriere® Motion™ Appliance in people with Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions and Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions, Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements
- What is being tested?
- Carriere® Motion™ Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 13 Jun 2019to 19 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Class II molar relationship.
- Full set of teeth from 1st molar to 1st molar.
- Age: between 12 and 20 years.
Who cannot join
- Craniofacial deformities.
- Previous orthodontic treatment.
- History of respiratory illness.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Carriere® Motion™ Appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carriere® Motion™ ApplianceDevice
class II malocclusion corrector
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | treated by Carriere® Motion™ Appliance Receives: Device: Carriere® Motion™ Appliance |
| control group | No intervention | no treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
cephalometric pharyngeal airway changes (linear cephalometric measurements in mm)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start13 Jun 2019
- Primary completion20 Jun 2021
- Study completion19 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Carriere® Motion™ Appliance on Pharyngeal Airway DimensionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Slaha Aljohani, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04900077
- Sponsor's protocol ID
- 022-01-19
- Other IDs
- 1532-165-1440
- Status last verified
- Mar 2022
- First submitted
- 5 May 2021
- Last updated
- 5 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions: A Prospective Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT04900077
- Acronym / sponsor ID
- 022-01-19
- Conditions
- Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions, Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 13 Jun 2019 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 19 Jan 2022 (actual)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: Carriere® Motion™ Appliancetreated by Carriere® Motion™ Appliance |
| control group | No intervention | –no treatment |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Class II molar relationship.
- Full set of teeth from 1st molar to 1st molar.
- Age: between 12 and 20 years.
Key exclusion criteria (3 listed)
- Craniofacial deformities.
- Previous orthodontic treatment.
- History of respiratory illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carriere® Motion™ Applianceclass II malocclusion corrector | Device | treatment group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carriere® Motion™ Appliance in people with Effect of Carriere® Motion™ Appliance on Pharyngeal Airway Dimensions and Effect of Carriere® Motion™ Appliance on Skeletal and Dental Measurements, run by King Abdulaziz University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2022.