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OpenTrials
Completed

NCT Number: NCT01268852

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

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.

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Key information

Conditions

Orthodontic Treatment DamonQ Brackets Fixed Appliances Insignia

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics and Craniofacial Biology

Nijmegen, Gelderland, 6500HB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Damon self ligating orthodontic bracket

Device

Orthodontic treatment with Damon self ligating bracket

Insignia self ligating orthodontic bracket

Device

Orthodontic treatment with Insignia self ligating bracket

Primary outcomes

  1. Total treatment duration

    Time frame: treatment duration

    duration assesed from start treatment to the removal of appliances

Secondary outcomes

  1. Quality of treatment

    Time frame: 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

    Time frame: at start of treatment

    time in minutes with planning the treatment

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Dec 31, 2010
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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