Arch Dimension and Inclination of the Upper and Lower Incisors Changes

NCT ID: NCT03129919

Last Updated: 2017-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-04-01

Brief Summary

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It is intended to evaluate changes in arch dimensions and incisor inclination as well as changes in the WALA Ridge in no extraction patients treated with interactive self-ligating brackets (Empower®) and passive (Carriere SLX®) at the end of the phase of alignment and leveling. For this, study models and profile radiographs taken before the start of treatment and at the end of the alignment and leveling phase will be evaluated. The parameters to be measured are: intercanine distance, arch depth, upper and lower incisor inclination, and WALA ridge analysis

Detailed Description

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Conditions

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Malocclusion, Angle Class I

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Orthodontic patients treated with brackets Carriere SLX®

Subjects requiring orthodontic treatment and will be treated with passive self-ligating braces Carriere SLX®

Group Type EXPERIMENTAL

Carriere SLX® (Passive self-ligating braces)

Intervention Type DEVICE

Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment

Orthodontic patients treated with brackets Empower®

Subjects requiring orthodontic treatment and will be treated with interactive self-ligating braces Empower®

Group Type ACTIVE_COMPARATOR

Empower® (Interactive self-ligating braces)

Intervention Type DEVICE

Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment

Interventions

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Carriere SLX® (Passive self-ligating braces)

Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment

Intervention Type DEVICE

Empower® (Interactive self-ligating braces)

Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Complete permanent dentition, except third molars.
* Class I malocclusion, determined by Angle ANB 2 plus or minus 2
* Visible alveolar teeth and ridges in plaster models, the latter being compatible and checked against the morphology of the WALA Ridge clinically presented by the patient.
* Little index with minimum Irregularity 4-6 mm.
* Patients with x-rays of initial profile and at the end of alignment and leveling in good condition.

Exclusion Criteria

* Models in poor condition that do not allow measurements.
* Patients who do not wish to participate in the study
* Patients with cleft lip and palate
* Patients with craniofacial anomalies
* Patients with previous orthodontic treatment
Minimum Eligible Age

16 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Universitaria CIEO

OTHER

Sponsor Role lead

Responsible Party

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Claudia Vivian Forero Manrique

Self-ligating clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Claudia Forero

Role: PRINCIPAL_INVESTIGATOR

Central Contacts

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CLAUDIA FORERO

Role: CONTACT

57-1-7437919

Other Identifiers

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0001

Identifier Type: -

Identifier Source: org_study_id

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