Crossbow Versus Forsus Springs in Mild to Moderate Class II Malocclusion Cases

NCT01530516 | Completed

• 1 other identifier: Pro00021423
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malocclusion, Angle Class II

Keywords

Malocclusion, Angle Class II

Outcome Measures

Primary Outcomes (1)

• Facial soft tissue, dental and skeletal changes

  Outcomes to be measured from Computer Beam Computer Tomography data and dental casts.

  24 months

Secondary Outcomes (2)

• Root resorption

  24 months

• Enamel decalcification

  24 months

Study Arms (2)

Full brackets plus Forsus springs

ACTIVE COMPARATOR

Standard of care - Class II springs used after le el and alignment.

Device: Brackets plus Forsus springs

Xbow plus full brackets

EXPERIMENTAL

Alternative treatment - First use the Xbow appliance and then full brackets after Class II occlusion has been corrected.

Device: Xbow plus full brackets

Interventions

Brackets plus Forsus springs DEVICE

Full brackets and after completion of level and alignment insertion of Class II correctors (Forsus spring devices).

Also known as: Forsus™ Fatigue Resistant Device

Full brackets plus Forsus springs

Xbow plus full brackets DEVICE

Xbow appliance to be inserted first. After anteroposterior changes have been completed full brackets will be bonded and occlusion fine tuned

Also known as: Xbow Class II corrector

Xbow plus full brackets

Eligibility Criteria

• Age: 11 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Severe vertical growth tendency or syndromic cases.
• Craniofacial growth completed.

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Edmonton Clinic

Edmonton, Alberta, T6G 1C9, Canada

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Carlos Flores Mir, DDS, FRCD(O)

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2012
• First Posted: February 10, 2012
• Study Start: October 1, 2012
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2020
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)