Predictability of Distalization and Derotation of the Carriere Motion Appliance.

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.

Study Overview

• Status: Completed
• Conditions: Dental Malocclusion
• Intervention / Treatment: Device: Carriere Motion Appliance®

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Castilla Leon
    • Salamanca, Castilla Leon, Spain, 37008
      • University of Salamanca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Permanent dentition
• Adults
• Dental Class I, III

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Canine and molar distalization and molar derotation; 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Canine Distalization	1.193 mm	4 months
Mean Molar Distalization	1.34 mm	4 months
Mean Molar Derotation	6.333º	4 months

Collaborators and Investigators

• Sponsor: University of Salamanca
• Investigators: Principal Investigator: Aldara Nercellas Rodríguez, University of Salamanca

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): November 20, 2020
• Study Completion (Actual): March 20, 2021

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 25, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 25, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Distalization; Class II malocclusion; Carriere Motion Appliance; Derotation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: UniversidadSalamanca

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No