Crossbow Versus Forsus Springs in Mild to Moderate Class II Malocclusion Cases
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Purpose
Class II malocclusion (mismatch between the upper and lower jaw in which the lower jaw appears to be smaller from a profile point of view) are common in the general population. Around 1/3 of the population have some degree of this skeletal/dental problem and it is one frequent reason why patients decide to undergo orthodontic treatment. Treatment alternatives will basically depend on the facial skeletal development of the patient and also on the magnitude of the skeletal/dental discrepancy.
For patients that are not yet fully skeletal mature, the treatment of mild to moderate Class II malocclusion involves a combination of a small skeletal growth modification effect and more significant dental movements. For skeletal mature individuals with a severe mismatch, the treatment usually involves jaw surgery to fully correct the malocclusion. For less severe cases orthodontic camouflage exclusively done by orthodontic movements is an option.
If the case is not severe enough to warrant a surgical approach there are several treatment alternatives. One of the most commonly used options is the use of orthodontic loaded springs that apply forces through brackets and arch wires bonded into the teeth so that the teeth will interrelate better.
A different alternative was proposed some years ago. The Xbow (spelled Crossbow) appliance differs from the above-proposed option in that no brackets are bonded or arch wires used. The orthodontic springs are applied to a metal framework cemented on some upper and lower teeth. Once the skeletal/dental problem is believed to have been significantly improved, fine tuning of the remaining dental problems is managed with brackets and arch wires. The theoretical advantage of such a design is that adverse effects, such as root resorption and decalcification from the long-term use of brackets and arch wires, are theoretically minimized as the brackets and arch wires have to be used for a shorter period of time.
Although there are some retrospective reports about the skeletal and dental effects of the Xbow appliance and only one prospective trial comparing the skeletal and dental changes to a non-treated growing sample; no randomized clinical trial has yet evaluated the changes compared to a current standard of care alternative which is the simultaneous use of loaded springs concurrent with brackets and arch wires.
| Condition | Intervention | Phase |
|---|---|---|
|
Malocclusion, Angle Class II |
Device: Brackets plus Forsus springs Device: Xbow plus full brackets |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | 3D Changes Comparing the Crossbow Appliance and Later Full Fixed Brackets Against Simultaneous Use of Full Fixed Brackets Plus Forsus Springs Among Mild to Moderate Class II Malocclusion Cases: A Randomized Clinical Trial. |
- Facial soft tissue, dental and skeletal changes [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Outcomes to be measured from Computer Beam Computer Tomography data and dental casts.
- Root resorption [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Evaluation of the magnitude of external root resorption as quantified/qualified from the CBCT data.
- Enamel decalcification [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]Enamel decalcification as clinically determined by observing and touching the enamel surfaces of teeth.
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Full brakets plus Forsus springs
Standard of care.
|
Device: Brackets plus Forsus springs
Full brackets and after completion of level and alignment insertion of Class II correctors (Forsus spring devices).
Other Name: Forsus™ Fatigue Resistant Device
|
|
Experimental: Xbow plus full brackets
Alternative treatment
|
Device: Xbow plus full brackets
Xbow appliance to be inserted first. After anteroposterior changes have been completed full brackets will be bonded and occlusion fine tuned
Other Name: Xbow Class II corrector
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 11 Years to 15 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Participants will be of either gender between 11 and 15 years-of-age.
- They will have mild to moderate Class II division 1 malocclusions.
- Late mixed dentition or early permanent dentition.
Exclusion Criteria:
- Severe vertical growth tendency or syndromic cases.
- Craniofacial growth completed.
Contacts and Locations| Canada, Alberta | |
| Edmonton Clinic | Recruiting |
| Edmonton, Alberta, Canada, T6G 1C9 | |
| Contact: Jacinthe Lelievre-Frank (780) 4924469 jacinthe@ualberta.ca | |
| Contact: Susan Helwig shelwig@ualberta.ca | |
| Principal Investigator: Carlos Flores-Mir, DSc | |
| Principal Investigator: | Carlos Flores Mir, DDS, FRCD(O) | University of Alberta |
More Information
No publications provided
| Responsible Party: | Carlos Flores-Mir, Associate Professor and Division Head of Orthodontics, University of Alberta, Graduate Orthodontic Program |
| ClinicalTrials.gov Identifier: | NCT01530516 History of Changes |
| Other Study ID Numbers: | Pro00021423 |
| Study First Received: | February 7, 2012 |
| Last Updated: | January 18, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Alberta, Graduate Orthodontic Program:
|
Malocclusion, Angle Class II |
Additional relevant MeSH terms:
|
Malocclusion Malocclusion, Angle Class II Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013