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Predictability of Distalization and Derotation of the Carriere Motion Appliance.

Primary Purpose

Dental Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Carriere Motion Appliance®
Sponsored by
University of Salamanca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Malocclusion focused on measuring Class II malocclusion, Carriere Motion Appliance, Distalization, Derotation

Eligibility Criteria

10 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Salamanca

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Canine and molar distalization and molar derotation

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean Canine Distalization
1.193 mm
Mean Molar Distalization
1.34 mm
Mean Molar Derotation
6.333º

Secondary Outcome Measures

Full Information

First Posted
September 28, 2021
Last Updated
October 25, 2021
Sponsor
University of Salamanca
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1. Study Identification

Unique Protocol Identification Number
NCT05094973
Brief Title
Predictability of Distalization and Derotation of the Carriere Motion Appliance.
Official Title
Predictability of Distalization and Derotation of the Carriere Motion Appliance. A Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
March 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Salamanca

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Malocclusion
Keywords
Class II malocclusion, Carriere Motion Appliance, Distalization, Derotation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canine and molar distalization and molar derotation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Carriere Motion Appliance®
Intervention Description
To analyze the distalization or distal tooth displacement and derotation angle produced by Carriere Motion Appliance® in a period of 4 months.
Primary Outcome Measure Information:
Title
Mean Canine Distalization
Description
1.193 mm
Time Frame
4 months
Title
Mean Molar Distalization
Description
1.34 mm
Time Frame
4 months
Title
Mean Molar Derotation
Description
6.333º
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aldara Nercellas Rodríguez
Organizational Affiliation
University of Salamanca
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Salamanca
City
Salamanca
State/Province
Castilla Leon
ZIP/Postal Code
37008
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Predictability of Distalization and Derotation of the Carriere Motion Appliance.

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