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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Radboud University
ClinicalTrials.gov Identifier:
NCT01268852
First received: December 28, 2010
Last updated: June 4, 2013
Last verified: December 2010
  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:


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


Enrollment: 180
Study Start Date: January 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT01268852     History of Changes
Other Study ID Numbers: Insignia versus Damon Q
Study First Received: December 28, 2010
Last Updated: June 4, 2013
Health Authority: The Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

ClinicalTrials.gov processed this record on September 16, 2014