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

Orthodontic Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01268852
• Other study ID #: Insignia versus Damon Q
• Status: Completed
• Phase: N/A
• First received: December 28, 2010
• Last updated: February 16, 2017
• Start date: January 2011
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• DamonQ Brackets
• Fixed Appliances
• Insignia
• Orthodontic Treatment

Intervention

Device:
• Damon self ligating orthodontic bracket
Orthodontic treatment with Damon self ligating bracket
• Insignia self ligating orthodontic bracket
Orthodontic treatment with Insignia self ligating bracket

Locations

Country	Name	City	State
Netherlands	Department of Orthodontics and Craniofacial Biology	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total treatment duration	duration assesed from start treatment to the removal of appliances	treatment duration
Secondary	Quality of treatment	Using one quality grading system: PAR-index	at start of treatment wand when finished treatment
Secondary	Difference between the planning and the outcome of treatment of the Insignia cases	time in minutes with planning the treatment	at start of treatment