Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Radboud University.
Recruitment status was  Active, not recruiting
Information provided by (Responsible Party):
Radboud University Identifier:
First received: December 28, 2010
Last updated: June 4, 2013
Last verified: December 2010

December 28, 2010
June 4, 2013
January 2011
December 2013   (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 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 Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
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 Identifier (NCT Number) in Medline.
Active, not recruiting
January 2015
December 2013   (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
12 Years to 30 Years
Contact information is only displayed when the study is recruiting subjects
Insignia versus Damon Q
Radboud University
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