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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-07-31

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.

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Detailed Description

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Conditions

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Orthodontic Treatment Fixed Appliances Insignia DamonQ Brackets

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare treatment between two appliance systems

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Masking was done with generated cmputer randomisation and sealed opaque enveloppes

Study Groups

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Damon

Standard self ligating orthodontic Damon brackets

Group Type ACTIVE_COMPARATOR

Damon self ligating orthodontic bracket

Intervention Type DEVICE

Orthodontic treatment with Damon self ligating bracket

Insignia

Innovative self ligating orthodontic bracket

Group Type EXPERIMENTAL

Insignia self ligating orthodontic bracket

Intervention Type DEVICE

Orthodontic treatment with Insignia self ligating bracket

Interventions

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Damon self ligating orthodontic bracket

Orthodontic treatment with Damon self ligating bracket

Intervention Type DEVICE

Insignia self ligating orthodontic bracket

Orthodontic treatment with Insignia self ligating bracket

Intervention Type DEVICE

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No