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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
December 28, 2010
February 16, 2017
January 2011
July 2015   (Final data collection date for primary outcome measure)
Total treatment duration [ Time Frame: treatment duration ]
duration assesed from start treatment to the removal of appliances
Total treatment duration [ Time Frame: before, during and after treatment ]
time from start treatment to the removal of appliances
Complete list of historical versions of study NCT01268852 on ClinicalTrials.gov Archive Site
  • 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
  • Quality of treatment [ Time Frame: before, during and after treatment ]
    Using two quality grading systems: PAR-index and ABO index
  • Difference between the planning and the outcome of treatment of the Insignia cases [ Time Frame: before. during and after treatment ]
  • Cost effectiveness [ Time Frame: before, during and after treatment ]
    Between the Damon Q cases compared with the Insignia cases
Not Provided
Not Provided
 
Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
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.
Not Provided
Interventional
Not Provided
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
  • Orthodontic Treatment
  • Fixed Appliances
  • Insignia
  • DamonQ Brackets
  • Device: Damon self ligating orthodontic bracket
    Orthodontic treatment with Damon self ligating bracket
  • Device: Insignia self ligating orthodontic bracket
    Orthodontic treatment with Insignia self ligating bracket
  • Active Comparator: Damon
    Standard self ligating orthodontic Damon brackets
    Intervention: Device: Damon self ligating orthodontic bracket
  • Experimental: Insignia
    Innovative self ligating orthodontic bracket
    Intervention: Device: Insignia self ligating orthodontic bracket
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
July 2015
July 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years to 30 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01268852
Insignia versus Damon Q
No
Not Provided
Not Provided
Radboud University
Radboud University
Not Provided
Principal Investigator: Hero Breuning Radboud university Medical centre Nijmegen, The Netherlands
Radboud University
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP