Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
This study is ongoing, but not recruiting participants.
Sponsor:
Radboud University
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
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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
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 June 18, 2013