Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 28, 2010
CompletedFirst Posted
Study publicly available on registry
December 31, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedFebruary 17, 2017
January 1, 2016
4.5 years
December 28, 2010
February 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Total treatment duration
duration assesed from start treatment to the removal of appliances
treatment duration
Secondary Outcomes (2)
Quality of treatment
at start of treatment wand when finished treatment
Difference between the planning and the outcome of treatment of the Insignia cases
at start of treatment
Study Arms (2)
Damon
ACTIVE COMPARATORStandard self ligating orthodontic Damon brackets
Insignia
EXPERIMENTALInnovative self ligating orthodontic bracket
Interventions
Orthodontic treatment with Damon self ligating bracket
Orthodontic treatment with Insignia self ligating bracket
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Orthodontics and Craniofacial Biology
Nijmegen, Gelderland, 6500HB, Netherlands
Related Publications (1)
Penning EW, Peerlings RHJ, Govers JDM, Rischen RJ, Zinad K, Bronkhorst EM, Breuning KH, Kuijpers-Jagtman AM. Orthodontics with Customized versus Noncustomized Appliances: A Randomized Controlled Clinical Trial. J Dent Res. 2017 Dec;96(13):1498-1504. doi: 10.1177/0022034517720913. Epub 2017 Jul 25.
PMID: 28742420DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Hero Breuning
Radboud university Medical centre Nijmegen, The Netherlands
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Masking was done with generated cmputer randomisation and sealed opaque enveloppes
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2010
First Posted
December 31, 2010
Study Start
January 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
February 17, 2017
Record last verified: 2016-01