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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01268852

Enrollment

180

Registered

2010-12-31

Start date

2011-01-31

Completion date

2015-07-31

Last updated

2017-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

DamonQ Brackets, Fixed Appliances, Insignia, Orthodontic Treatment

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.

Interventions

DEVICEDamon self ligating orthodontic bracket

Orthodontic treatment with Damon self ligating bracket

DEVICEInsignia self ligating orthodontic bracket

Orthodontic treatment with Insignia self ligating bracket

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Investigator, Outcomes Assessor)

Masking description

Masking was done with generated cmputer randomisation and sealed opaque enveloppes

Intervention model description

Compare treatment between two appliance systems

Eligibility

Sex/Gender

ALL

Age

12 Years to 30 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Total treatment duration	treatment duration	duration assesed from start treatment to the removal of appliances

Secondary

Measure	Time frame	Description
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026