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
About this trial
This is an interventional treatment trial for Malocclusion, Angle Class I
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
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
NCT ID
NCT03129919
First Posted
March 22, 2017
Last Updated
April 25, 2017
Sponsor
Fundación Universitaria CIEO
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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