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

Study Overview
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Brief Summary
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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.

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

Conditions
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Orthodontic Treatment, Fixed Appliances, Insignia, DamonQ Brackets

Intervention / Treatment
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* Device: Damon self ligating orthodontic bracket
* Device: Insignia self ligating orthodontic bracket


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compare treatment between two appliance systems
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Damon<br>Standard self ligating orthodontic Damon brackets | Device: Damon self ligating orthodontic bracket<br>* Orthodontic treatment with Damon self ligating bracket<br>|
| Experimental: Insignia<br>Innovative self ligating orthodontic bracket | Device: Insignia self ligating orthodontic bracket<br>* Orthodontic treatment with Insignia self ligating bracket<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total treatment duration | duration assesed from start treatment to the removal of appliances | treatment duration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of treatment | Using one quality grading system: PAR-index | at start of treatment wand when finished treatment | 
| Difference between the planning and the outcome of treatment of the Insignia cases | time in minutes with planning the treatment | at start of treatment |