Orthodontic TreatmentNCT01268852
Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
A study testing Damon self ligating orthodontic bracket and Insignia self ligating orthodontic bracket in people with Orthodontic Treatment and Fixed Appliances, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Orthodontic Treatment, Fixed Appliances, Insignia
- What is being tested?
- Damon self ligating orthodontic bracket and Insignia self ligating orthodontic bracket
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- History of periodontal disease
- Intake of drugs affecting tooth movement and/or bone formation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Department of Orthodontics and Craniofacial Biology
Nijmegen, Gelderland, 6500HB
About this study
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.
- Conditions
- Orthodontic Treatment, Fixed Appliances, Insignia, DamonQ Brackets
- Being tested
- Damon self ligating orthodontic bracket, Insignia self ligating orthodontic bracket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damon self ligating orthodontic bracketDevice
Orthodontic treatment with Damon self ligating bracket
Insignia self ligating orthodontic bracketDevice
Orthodontic treatment with Insignia self ligating bracket
| Study group | Role | What they receive |
|---|---|---|
| Damon | Active comparator | Standard self ligating orthodontic Damon brackets Receives: Device: Damon self ligating orthodontic bracket |
| Insignia | Experimental | Innovative self ligating orthodontic bracket Receives: Device: Insignia self ligating orthodontic bracket |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total treatment duration
duration assesed from start treatment to the removal of appliances
Measured: treatment duration
Secondary outcomes (2)
Quality of treatment
Using one quality grading system: PAR-index
Measured: at start of treatment wand when finished treatment
Difference between the planning and the outcome of treatment of the Insignia cases
time in minutes with planning the treatment
Measured: at start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Orthodontic TreatmentStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Compare treatment between two appliance systems
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hero Breuning, Principal investigator, Radboud university Medical centre Nijmegen, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01268852
- Sponsor's protocol ID
- Insignia versus Damon Q
- Status last verified
- Jan 2016
- First submitted
- 28 Dec 2010
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28742420
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Insignia ™ Versus Standard Orthodontic Treatment With Damon Q Brackets
- ClinicalTrials.gov ID
- NCT01268852
- Acronym / sponsor ID
- Insignia versus Damon Q
- Conditions
- Orthodontic Treatment, Fixed Appliances, Insignia, DamonQ Brackets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 31 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Compare treatment between two appliance systems
| Arm | Type | Receives |
|---|---|---|
| Damon | Active comparator | Device: Damon self ligating orthodontic bracketStandard self ligating orthodontic Damon brackets |
| Insignia | Experimental | Device: Insignia self ligating orthodontic bracketInnovative self ligating orthodontic bracket |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- Cleft lip and palate and craniofacial anomalies
- Syndromes affecting bone (formation) or teeth
- Agenesis of teeth
- Missing first molars
- No bridges or implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damon self ligating orthodontic bracketOrthodontic treatment with Damon self ligating bracket | Device | Damon |
| Insignia self ligating orthodontic bracketOrthodontic treatment with Insignia self ligating bracket | Device | Insignia |
Primary outcome
Total treatment duration
Time frame: treatment duration
duration assesed from start treatment to the removal of appliances
2 secondary outcomes
Quality of treatment
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Derived from this study: PubMed 28742420Penning 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hero Breuning principal investigator
Radboud university Medical centre Nijmegen, The Netherlands
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Damon self ligating orthodontic bracket and Insignia self ligating orthodontic bracket in people with Orthodontic Treatment and Fixed Appliances, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total treatment duration (time frame: treatment duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01268852, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.