NCT05094973

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

September 28, 2021

Last Update Submit

October 25, 2021

Conditions

Dental Malocclusion

Keywords

Class II malocclusionCarriere Motion ApplianceDistalizationDerotation

Outcome Measures

Primary Outcomes (3)

  • Mean Canine Distalization

    1.193 mm

    4 months

  • Mean Molar Distalization

    1.34 mm

    4 months

  • Mean Molar Derotation

    6.333º

    4 months

Study Arms (1)

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.

Device: Carriere Motion Appliance®

Interventions

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.

Canine and molar distalization and molar derotation

Eligibility Criteria

Age10 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Permanent dentition
  • Adults
  • Dental Class I, III

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Salamanca

Salamanca, Castille and León, 37008, Spain

Location

MeSH Terms

Conditions

MalocclusionOverbite

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesMalocclusion, Angle Class II

Study Officials

  • Aldara Nercellas Rodríguez

    University of Salamanca

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: This study included 15 patients with Class II molar relationship and Class II canine relationship treated using Carriere Motion Appliance®.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 26, 2021

Study Start

November 20, 2020

Primary Completion

November 20, 2020

Study Completion

March 20, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)