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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01268852
First received: December 28, 2010
Last updated: February 16, 2017
Last verified: January 2016
  Purpose
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 Intervention
Orthodontic Treatment Fixed Appliances Insignia DamonQ Brackets Device: Damon self ligating orthodontic bracket Device: Insignia self ligating orthodontic bracket

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radboud University:

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


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

  • 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


Enrollment: 180
Study Start Date: January 2011
Study Completion Date: July 2015
Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01268852     History of Changes
Other Study ID Numbers: Insignia versus Damon Q
Study First Received: December 28, 2010
Last Updated: February 16, 2017

ClinicalTrials.gov processed this record on August 21, 2017