Arch Dimension and Inclination of the Upper and Lower Incisors Changes

Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets

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

Study Overview

• Status: Unknown
• Conditions: Malocclusion, Angle Class I
• Intervention / Treatment: Device: Carriere SLX® (Passive self-ligating braces); Device: Empower® (Interactive self-ligating braces)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 35 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Orthodontic patients treated with brackets Carriere SLX®; Subjects requiring orthodontic treatment and will be treated with passive self-ligating braces Carriere SLX®	Device: 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
ACTIVE_COMPARATOR: Orthodontic patients treated with brackets Empower®; Subjects requiring orthodontic treatment and will be treated with interactive self-ligating braces Empower®	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incisomaxillary angle	Angle formed by the palatal plane and the upper incisor	At the end of the alignment and leveling phase, an average of 8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transverse development of the upper and lower jaws	Cuspal and basal intercanine distance	Each time wire is changed in the sequence suggested by the author, an average of 3 months
Inclination of the lower incisor	Incisal mandibular plane angle	At the end of the alignment and leveling phase, an average of 8 months

Collaborators and Investigators

• Sponsor: Fundación Universitaria CIEO
• Investigators: Principal Investigator: Claudia Forero

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 15, 2017
• Primary Completion (ANTICIPATED): April 1, 2018
• Study Completion (ANTICIPATED): April 1, 2018

Study Registration Dates

• First Submitted: March 22, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (ACTUAL): April 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2017
• Last Update Submitted That Met QC Criteria: April 25, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Malocclusion, Angle Class I
• Other Study ID Numbers: 0001 (Researcher)

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