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Arch Dimension and Inclination of the Upper and Lower Incisors Changes

Primary Purpose

Malocclusion, Angle Class I

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Carriere SLX® (Passive self-ligating braces)
Empower® (Interactive self-ligating braces)
Sponsored by
Fundación Universitaria CIEO
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class I

Eligibility Criteria

16 Years - 35 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Orthodontic patients treated with brackets Carriere SLX®

    Orthodontic patients treated with brackets Empower®

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Incisomaxillary angle
    Angle formed by the palatal plane and the upper incisor

    Secondary Outcome Measures

    Transverse development of the upper and lower jaws
    Cuspal and basal intercanine distance
    Inclination of the lower incisor
    Incisal mandibular plane angle

    Full Information

    First Posted
    March 22, 2017
    Last Updated
    April 25, 2017
    Sponsor
    Fundación Universitaria CIEO
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03129919
    Brief Title
    Arch Dimension and Inclination of the Upper and Lower Incisors Changes
    Official Title
    Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 15, 2017 (Anticipated)
    Primary Completion Date
    April 1, 2018 (Anticipated)
    Study Completion Date
    April 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fundación Universitaria CIEO

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malocclusion, Angle Class I

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Orthodontic patients treated with brackets Carriere SLX®
    Arm Type
    Experimental
    Arm Description
    Subjects requiring orthodontic treatment and will be treated with passive self-ligating braces Carriere SLX®
    Arm Title
    Orthodontic patients treated with brackets Empower®
    Arm Type
    Active Comparator
    Arm Description
    Subjects requiring orthodontic treatment and will be treated with interactive self-ligating braces Empower®
    Intervention Type
    Device
    Intervention Name(s)
    Carriere SLX® (Passive self-ligating braces)
    Intervention Description
    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
    Intervention Name(s)
    Empower® (Interactive self-ligating braces)
    Intervention Description
    Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment
    Primary Outcome Measure Information:
    Title
    Incisomaxillary angle
    Description
    Angle formed by the palatal plane and the upper incisor
    Time Frame
    At the end of the alignment and leveling phase, an average of 8 months
    Secondary Outcome Measure Information:
    Title
    Transverse development of the upper and lower jaws
    Description
    Cuspal and basal intercanine distance
    Time Frame
    Each time wire is changed in the sequence suggested by the author, an average of 3 months
    Title
    Inclination of the lower incisor
    Description
    Incisal mandibular plane angle
    Time Frame
    At the end of the alignment and leveling phase, an average of 8 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    CLAUDIA FORERO
    Phone
    57-1-7437919
    Email
    claudiavivian@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Claudia Forero
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Arch Dimension and Inclination of the Upper and Lower Incisors Changes

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