Arch Dimension and Inclination of the Upper and Lower Incisors Changes

NCT03129919 | Unknown

• 1 other identifier: 0001
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Malocclusion, Angle Class I

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Transverse development of the upper and lower jaws

  Each time wire is changed in the sequence suggested by the author, an average of 3 months

• Inclination of the lower incisor

  At the end of the alignment and leveling phase, an average of 8 months

Study Arms (2)

Orthodontic patients treated with brackets Carriere SLX®

EXPERIMENTAL

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

Device: Carriere SLX® (Passive self-ligating braces)

Orthodontic patients treated with brackets Empower®

ACTIVE COMPARATOR

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

Device: Empower® (Interactive self-ligating braces)

Interventions

Carriere SLX® (Passive self-ligating braces) 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 Carriere SLX®

Empower® (Interactive self-ligating braces) 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®

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Universitaria CIEO: lead

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Claudia Forero

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CLAUDIA FORERO

CONTACT

57-1-7437919; claudiavivian@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Self-ligating clinical professor

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 26, 2017
• Study Start: May 15, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share