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

• Sponsor: Radboud University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01268852
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Duration (Months): 53.9
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Treatment; Fixed Appliances; Insignia; DamonQ Brackets	Device: Damon self ligating orthodontic bracket; Device: Insignia self ligating orthodontic bracket	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Compare treatment between two appliance systemsCompare treatment between two appliance systems
• Masking: Double (Investigator, Outcomes Assessor)
• Masking Description: Masking was done with generated cmputer randomisation and sealed opaque enveloppes
• Primary Purpose: Treatment
• Official Title: Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Damon Standard self ligating orthodontic Damon brackets	Device: Damon self ligating orthodontic bracket; Orthodontic treatment with Damon self ligating bracket
Experimental: Insignia Innovative self ligating orthodontic bracket	Device: Insignia self ligating orthodontic bracket; Orthodontic treatment with Insignia self ligating bracket

Outcome Measures

Primary Outcome Measures

1. Total treatment duration [treatment duration]

   duration assesed from start treatment to the removal of appliances

Secondary Outcome Measures

1. Quality of treatment [at start of treatment wand when finished treatment]

   Using one quality grading system: PAR-index

2. Difference between the planning and the outcome of treatment of the Insignia cases [at start of treatment]

   time in minutes with planning the treatment

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Orthodontics and Craniofacial Biology	Nijmegen	Gelderland	Netherlands	6500HB

Sponsors and Collaborators

• Radboud University Medical Center

Investigators

• Principal Investigator: Hero Breuning, Radboud university Medical centre Nijmegen, The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Radboud University Medical Center
• ClinicalTrials.gov Identifier: NCT01268852
• Other Study ID Numbers: Insignia versus Damon Q
• First Posted: Dec 31, 2010
• Last Update Posted: Feb 17, 2017
• Last Verified: Jan 1, 2016

Study Results

No Results Posted as of Feb 17, 2017