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Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets

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ClinicalTrials.gov Identifier: NCT01268852
Recruitment Status : Completed
First Posted : December 31, 2010
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

Brief Summary:
The hypotheses tested in this study are: There is a statistical significant difference, in treatment duration and result of treatment in cases treated using traditional Damon Q brackets or using Insignia.

Condition or disease Intervention/treatment
Orthodontic Treatment Fixed Appliances Insignia DamonQ Brackets Device: Damon self ligating orthodontic bracket Device: Insignia self ligating orthodontic bracket

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Compare treatment between two appliance systems
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Masking was done with generated cmputer randomisation and sealed opaque enveloppes
Primary Purpose: Treatment
Official Title: Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
Study Start Date : January 2011
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Damon
Standard self ligating orthodontic Damon brackets
Device: Damon self ligating orthodontic bracket
Orthodontic treatment with Damon self ligating bracket
Experimental: Insignia
Innovative self ligating orthodontic bracket
Device: Insignia self ligating orthodontic bracket
Orthodontic treatment with Insignia self ligating bracket



Primary Outcome Measures :
  1. Total treatment duration [ Time Frame: treatment duration ]
    duration assesed from start treatment to the removal of appliances


Secondary Outcome Measures :
  1. Quality of treatment [ Time Frame: at start of treatment wand when finished treatment ]
    Using one quality grading system: PAR-index

  2. Difference between the planning and the outcome of treatment of the Insignia cases [ Time Frame: at start of treatment ]
    time in minutes with planning the treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy subjects, both male and female
  • No cleft lip or palate or other craniofacial anomalies
  • Treatment with full fixed orthodontic appliances is indicated
  • Complete permanent dentition except for upper second and all third molars
  • Class I, Class II or Class III first molar relationship )1/2 pb or less off)
  • No previous orthodontic treatment
  • Age between 12 and 30 years of age
  • Study models and lateral cephalograms taken not more than 1 month before selection
  • Informed consent signed by patients and parents

Exclusion Criteria:

  • Cleft lip and palate and craniofacial anomalies
  • Syndromes affecting bone (formation) or teeth
  • Agenesis of teeth
  • Missing first molars
  • No bridges or implants
  • Orthognathic cases
  • History of periodontal disease
  • Intake of drugs affecting tooth movement and/or bone formation
  • Pregnancy

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): NCT01268852


Locations
Netherlands
Department of Orthodontics and Craniofacial Biology
Nijmegen, Gelderland, Netherlands, 6500HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Hero Breuning Radboud university Medical centre Nijmegen, The Netherlands

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01268852     History of Changes
Other Study ID Numbers: Insignia versus Damon Q
First Posted: December 31, 2010    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: January 2016