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

This study has been completed.
Information provided by (Responsible Party):
Radboud University Identifier:
First received: December 28, 2010
Last updated: February 16, 2017
Last verified: January 2016
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
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: 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


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

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
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Please refer to this study by its identifier: NCT01268852

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

Responsible Party: Radboud University Identifier: NCT01268852     History of Changes
Other Study ID Numbers: Insignia versus Damon Q
Study First Received: December 28, 2010
Last Updated: February 16, 2017 processed this record on May 25, 2017