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

This study is not yet open for participant recruitment.
Verified December 2010 by Radboud University
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01268852
First received: December 28, 2010
Last updated: December 30, 2010
Last verified: December 2010
History of Changes

December 28, 2010
December 30, 2010
January 2011
August 2012   (final data collection date for primary outcome measure)
Total treatment duration [ Time Frame: before, during and after treatment ] [ Designated as safety issue: No ]
time from start treatment to the removal of appliances
Same as current
Complete list of historical versions of study NCT01268852 on ClinicalTrials.gov Archive Site
  • Quality of treatment [ Time Frame: before, during and after treatment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Cost effectiveness [ Time Frame: before, during and after treatment ] [ Designated as safety issue: No ]
    Between the Damon Q cases compared with the Insignia cases
Same as current
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
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
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Probability Sample

Patients are recruited after their recall from the list of patients waiting for active orthodontic therapy in the private office of orthodontist RP, situated in Zeeland and the private office of orthodontist JG situated in Noord Brabant (The Netherlands).
  • Orthodontic Treatment
  • Fixed Appliances
  • Insignia
  • DamonQ Brackets
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
180
January 2014
August 2012   (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
Both
12 Years to 30 Years
No
Contact: Hero Breuning, DDS PhD +31243617204 h.breuning@dent.umcn.nl
Contact: Robine Rischen, DDS + 31 24 3616947 r.rischen@dent.umcn.nl
Netherlands
 
NCT01268852
Insignia versus Damon Q
No
K.H.Breuning, Radboud University Nijmegen Medical Centre
Radboud University
Not Provided
Principal Investigator: Hero Breuning Radboud university Medical centre Nijmegen, The Netherlands
Radboud University
December 2010

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