Dental MalocclusionNCT05094973
Predictability of Distalization and Derotation of the Carriere Motion Appliance.
A study testing Carriere Motion Appliance® in people with Dental Malocclusion, run by University of Salamanca at 1 site in Spain.
Trial summary
To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® (CMA) by using a repeatable and reproducible measurement digital technique. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Dental Malocclusion
- 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
- 15 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2020to 20 Mar 2021
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Growing patients
- Late mixed dentition or permanent dentition
- Fully erupted definitive molars
- No history of previous orthodontic treatment
- Complete pre- and post-treatment records (digital study models)
- Dental Class II relationship.
Who cannot join
- Permanent dentition
- Adults
- Dental Class I, III
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictability of Distalization and Derotation of the Carriere Motion Appliance. A Clinical Study
To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® (CMA) by using a repeatable and reproducible measurement digital technique.
Read the detailed description
15 patients with Class II molar and canine relationship were submitted to orthodontic treatment with CMA. All patients were exposed preoperatively (STL1) and postoperatively (STL2) to a digital impression and afterwards were uploaded into a specific cephalometric software to allow the automatic mesh networks alignment of the STL digital files. Subsequently, the distal tooth displacement of upper canines and first upper molars and also the derotation angle of first upper molars were measured. The repeatability and reproducibility were analyzed by Gage R\&R statistical analysis.
- Conditions
- Dental Malocclusion
- Being tested
- Carriere Motion Appliance®
- Keywords
- Class II malocclusion, Carriere Motion Appliance, Distalization, Derotation
- Medical subject headings
- Malocclusion, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carriere Motion Appliance®Device
To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® in a period of 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Canine and molar distalization and molar derotation | Experimental | Evaluating the canine and molar distalization and molar derotation in dental Class II patients who where submitted to Carriere Motion Appliance® for a mean of 4 months. Receives: Device: Carriere Motion Appliance® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Canine Distalization
1.193 mm
Measured: 4 months
Mean Molar Distalization
1.34 mm
Measured: 4 months
Mean Molar Derotation
6.333º
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start20 Nov 2020
- Primary completion20 Nov 2020
- Study completion20 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental MalocclusionStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study included 15 patients with Class II molar relationship and Class II canine relationship treated using Carriere Motion Appliance®.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Salamanca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldara Rosalía Nercellas Rodríguez, University of Salamanca
- Investigators
- Aldara Nercellas Rodríguez, Principal investigator, University of Salamanca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094973
- Sponsor's protocol ID
- UniversidadSalamanca
- Status last verified
- Oct 2021
- First submitted
- 28 Sep 2021
- Last updated
- 26 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictability of Distalization and Derotation of the Carriere Motion Appliance. A Clinical Study
- ClinicalTrials.gov ID
- NCT05094973
- Acronym / sponsor ID
- UniversidadSalamanca
- Conditions
- Dental Malocclusion
- Keywords
- Class II malocclusion, Carriere Motion Appliance, Distalization, Derotation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of SalamancaUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 20 Nov 2020 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 26 Oct 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.
To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® (CMA) by using a repeatable and reproducible measurement digital technique.
Detailed description
15 patients with Class II molar and canine relationship were submitted to orthodontic treatment with CMA. All patients were exposed preoperatively (STL1) and postoperatively (STL2) to a digital impression and afterwards were uploaded into a specific cephalometric software to allow the automatic mesh networks alignment of the STL digital files. Subsequently, the distal tooth displacement of upper canines and first upper molars and also the derotation angle of first upper molars were measured. The repeatability and reproducibility were analyzed by Gage R\&R statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study included 15 patients with Class II molar relationship and Class II canine relationship treated using Carriere Motion Appliance®.
| Arm | Type | Receives |
|---|---|---|
| Canine and molar distalization and molar derotation | Experimental | Device: Carriere Motion Appliance®Evaluating the canine and molar distalization and molar derotation in dental Class II patients who where submitted to Carriere Motion Appliance® for a mean of 4 months. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Growing patients
- Late mixed dentition or permanent dentition
- Fully erupted definitive molars
- No history of previous orthodontic treatment
- Complete pre- and post-treatment records (digital study models)
Key exclusion criteria (3 listed)
- Permanent dentition
- Adults
- Dental Class I, III
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 Appliance®To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® in a period of 4 months. | Device | Canine and molar distalization and molar derotation |
Primary outcome
Mean Canine Distalization
Time frame: 4 months
1.193 mm
Mean Molar Distalization
Time frame: 4 months
1.34 mm
Mean Molar Derotation
Time frame: 4 months
6.333º
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 26 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Dental Malocclusion
Enrolling by invitation
Discision as Acceleration Method in Canine Retraction in Orthodontics With Aligner and Fixed Appliances in Young Adults a Split Mouth Study
Bimaxillary Protrusion, Class II Div 1 Malocclusion
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction
Not yet recruiting
Timing, Trajectories and Prediction in Severe Dental Crowding: The Create SPACE (cSPACE)
Crowding of Teeth, Malocclusion; Displaced Teeth
Recruiting
FM Technique in Orthodontic Clear Aligner Therapy: A Single-Arm Clinical Study
Malocclusion
Not yet recruiting
Treatment of Mandibular Overjet in Children With Maxillary Retrognathism
Maxillary Retrognathism, Children
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.
Aldara Nercellas Rodríguez principal investigator
University of Salamanca
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 Dental Malocclusion, run by University of Salamanca at 1 site in Spain.
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 6 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 26 Oct 2021. 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 Spain. 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?
Mean Canine Distalization (time frame: 4 months). The study lists 3 primary outcomes in all. 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 26 Oct 2021.