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

Not Applicable

Completed

• Conditions: Insignia; Orthodontic Treatment; Fixed Appliances; DamonQ Brackets
• Interventions: Device: Damon self ligating orthodontic bracket; Device: Insignia self ligating orthodontic bracket

• Registration Number: NCT01268852
• Lead Sponsor: Radboud University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-30
• Study First Posted: 2010-12-31
• Study Start: 2011-01
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-01
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Damon	Damon self ligating orthodontic bracket	Standard self ligating orthodontic Damon brackets
Insignia	Insignia self ligating orthodontic bracket	Innovative self ligating orthodontic bracket

Primary Outcome Measures

Name	Time	Method
Total treatment duration	treatment duration	duration assesed from start treatment to the removal of appliances

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Orthodontics and Craniofacial Biology; 🇳🇱 Nijmegen, Gelderland, Netherlands