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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
  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
Orthodontic Treatment
Fixed Appliances
Insignia
DamonQ Brackets

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets

Resource links provided by NLM:

MedlinePlus related topics: Orthodontia
U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • Total treatment duration [ Time Frame: before, during and after treatment ] [ Designated as safety issue: No ]
    time from start treatment to the removal of appliances


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 180
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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).

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01268852

Contacts
Contact: Hero Breuning, DDS PhD +31243617204 h.breuning@dent.umcn.nl
Contact: Robine Rischen, DDS + 31 24 3616947 r.rischen@dent.umcn.nl

Locations
Netherlands
Department of Orthodontics and Craniofacial Biology Not yet recruiting
Nijmegen, Gelderland, Netherlands, 6500HB
Contact: Hero Breuning, DDS PhD     +31243617204     h.breuning@dent.umcn.nl    
Contact: Robine Rischen, DDS     +31 24 3616947     r.rischen@dent.umcn.nl    
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Hero Breuning Radboud university Medical centre Nijmegen, The Netherlands
  More Information

No publications provided

Responsible Party: K.H.Breuning, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT01268852     History of Changes
Other Study ID Numbers: Insignia versus Damon Q
Study First Received: December 28, 2010
Last Updated: December 30, 2010
Health Authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on May 19, 2013