Predictability of Distalization and Derotation of the Car... | NCT05094973

Studies
Predictability of Distalization and Derotation of the Carriere Motion Appliance.

NCT05094973

Sponsor

University of Salamanca

Status

Completed

Last Update Posted

Oct 26, 2021Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Dental Malocclusion

Interventions

Carriere Motion Appliance®

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 20, 2020Actual

Primary Completion Date

Nov 20, 2020Actual

Completion Date

Mar 20, 2021Actual

First Submitted Date

Sep 28, 2021

First Submission Date that Met QC Criteria

Oct 25, 2021

First Posted Date

Oct 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2021

Last Update Posted Date

Oct 26, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Aldara Rosalía Nercellas Rodríguez, Principal Investigator, University of SalamancaPrincipal Investigator

Lead Sponsor

University of SalamancaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Aldara Nercellas Rodríguez	University of Salamanca	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Salamanca		Salamanca	Castille and León	37008	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008310	Malocclusion
D057887	Overbite

Ancestor Terms

ID	Term
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D008312	Malocclusion, Angle Class II

Browse Leaves

Not provided

Browse Branches

Not provided