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Arch Dimension and Inclination of the Upper and Lower Incisors Changes

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ClinicalTrials.gov Identifier: NCT03129919
Recruitment Status : Not yet recruiting
First Posted : April 26, 2017
Last Update Posted : April 26, 2017
Sponsor:
Information provided by (Responsible Party):
Claudia Vivian Forero Manrique, Fundación Universitaria CIEO

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

Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class I Device: Carriere SLX® (Passive self-ligating braces) Device: Empower® (Interactive self-ligating braces) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Arch Dimension and Inclination of the Upper and Lower Incisors Changes in Patients Treated With Interactive and Passive Self-ligation Brackets
Estimated Study Start Date : May 15, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : April 1, 2018

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




Primary Outcome Measures :
  1. Incisomaxillary angle [ Time Frame: At the end of the alignment and leveling phase, an average of 8 months ]
    Angle formed by the palatal plane and the upper incisor


Secondary Outcome Measures :
  1. Transverse development of the upper and lower jaws [ Time Frame: Each time wire is changed in the sequence suggested by the author, an average of 3 months ]
    Cuspal and basal intercanine distance

  2. Inclination of the lower incisor [ Time Frame: At the end of the alignment and leveling phase, an average of 8 months ]
    Incisal mandibular plane angle



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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129919


Contacts
Contact: CLAUDIA FORERO 57-1-7437919 claudiavivian@gmail.com

Sponsors and Collaborators
Fundación Universitaria CIEO
Investigators
Principal Investigator: Claudia Forero

Responsible Party: Claudia Vivian Forero Manrique, Self-ligating clinical professor, Fundación Universitaria CIEO
ClinicalTrials.gov Identifier: NCT03129919     History of Changes
Other Study ID Numbers: 0001
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Malocclusion
Malocclusion, Angle Class I
Tooth Diseases
Stomatognathic Diseases