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

February 16, 2017 updated by: Radboud University Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, 6500HB
        • Department of Orthodontics and Craniofacial Biology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 30 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total treatment duration
Time Frame: treatment duration
duration assesed from start treatment to the removal of appliances
treatment duration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of treatment
Time Frame: at start of treatment wand when finished treatment
Using one quality grading system: PAR-index
at start of treatment wand when finished treatment
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
at start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Investigators

  • Principal Investigator: Hero Breuning, Radboud University Medical Centre Nijmegen, the Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

December 28, 2010

First Submitted That Met QC Criteria

December 30, 2010

First Posted (Estimate)

December 31, 2010

Study Record Updates

Last Update Posted (Actual)

February 17, 2017

Last Update Submitted That Met QC Criteria

February 16, 2017

Last Verified

January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Insignia versus Damon Q

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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