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

Radboud University Medical Center

Status: Completed

Conditions: Orthodontic Treatment; DamonQ Brackets; Insignia; Fixed Appliances

Treatments: Device: Insignia self ligating orthodontic bracket; Device: Damon self ligating orthodontic bracket

Study type: Interventional

Funder types: Other

Identifiers

NCT01268852

Insignia versus Damon Q

Details and patient eligibility

About

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.

Enrollment: 180 patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

Damon

Active Comparator group

Description:

Standard self ligating orthodontic Damon brackets

Treatment:

Device: Damon self ligating orthodontic bracket

Insignia

Experimental group

Description:

Innovative self ligating orthodontic bracket

Treatment:

Device: Insignia self ligating orthodontic bracket