Upper Expansion Appliances for Overbite

Overseen By Rabia Njie, BDS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Other orthodontic treatment, Growth problems

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 9 months

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a device called an upper arch expansion appliance (also known as the Wilson 3D Quad Helix or Quad Helix Appliance) can help young children with an overbite by encouraging forward growth of the lower jaw. Children aged 9-11 with a lower jaw positioned further back than normal will receive either an active or non-active version of this appliance. The trial includes taking special x-rays before and after 9 months of treatment to observe changes. Children with an overbite due to a backward-positioned lower jaw and whose first permanent molars and incisors have erupted might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding how this device can benefit children with similar dental issues.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the upper arch Wilson quadhelex appliance is safe for young children?

Previous studies have shown that the quad helix appliance, such as the Wilson quadhelix, is generally safe for children. Dentists often use this device to correct dental issues like crossbites. Some children may experience slight discomfort initially, but this usually subsides quickly. Research has found that the Wilson quadhelix can significantly widen the upper jaw, improving dental alignment. Overall, the appliance is well-tolerated, with few side effects reported during its use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the upper arch Wilson quadhelex appliance because it offers a unique approach to correcting overbites. Unlike traditional braces or aligners, which primarily focus on aligning teeth, this appliance targets the upper arch specifically to create space and promote proper jaw alignment. This method could lead to improved outcomes for patients with overbites by addressing the underlying structural issues rather than just repositioning teeth. The potential for fewer adjustments and less discomfort during treatment also makes this appliance an appealing alternative to conventional options.

What evidence suggests that this trial's treatments could be effective for overbite?

Studies have shown that the Wilson 3D Quad-Helix appliance effectively widens the upper jaw in children, particularly those with a narrow upper arch or crossbite. This trial will compare two approaches: an active upper Wilson appliance and a non-active upper expansion appliance. The active appliance adjusts the position of the back teeth and improves the overall shape of the dental arch. Research indicates that it can be as effective, or even superior, to other devices for correcting dental issues like crossbites. Additionally, it typically causes minimal changes in jaw height, making it a stable choice for gradual widening. These findings suggest that this appliance could encourage forward growth of the lower jaw in young children. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for young children aged 9-11 with buck teeth or an overbite, specifically those whose lower jaw is positioned backward. They must be in the early mixed dentition stage, meaning they have their first permanent molars and upper and lower permanent incisors coming in.

Inclusion Criteria

Class II malocclusion

Early mixed dentition (all first permanent molars erupted, as well as all erupting upper and lower permanent incisors)

My lower jaw is positioned back, causing a skeletal class II issue.

Exclusion Criteria

History of growth problems (craniofacial syndromes, etc.)

I have received other orthodontic treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either an active or non-active Wilson type upper arch expansion appliance

9 months

2 visits (in-person) for CBCT imaging

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Upper arch Wilson quadhelex appliance

Trial Overview The study tests if a Wilson quadhelex appliance fitted to the upper jaw can encourage forward growth of the lower jaw in children. Participants will receive either an active or non-active appliance and undergo special x-rays before treatment and after nine months.

How Is the Trial Designed?

Group I: Active upper Wilson appliance Active Control 1 Intervention

Active upper arch Wilson quadhelex appliance

Group II: Non active upper expansion appliance Placebo Group 1 Intervention

Non-Active upper arch Wilson quadhelex appliance

Upper arch Wilson quadhelex appliance is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Wilson 3D Quad Helix for:

• Crossbites
• Crowded anteriors
• Excessive overjet
• Skeletal problems

Approved in European Union as Quad Helix Appliance for:

• Crossbites
• Crowded anteriors
• Excessive overjet
• Skeletal problems

Approved in Canada as Upper Arch Expansion Appliance for:

• Crossbites
• Crowded anteriors
• Excessive overjet
• Skeletal problems

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

University of Alberta, Graduate Orthodontic Program

Lead Sponsor

Trials

5

Recruited

230+

Published Research Related to This Trial

The maxillary quad-helix appliance is effective for treating maxillary arch constriction and posterior crossbite, particularly in growing children, by allowing for slow maxillary expansion.

Evidence supports the early use of the quad-helix appliance in mixed dentition cases, highlighting important factors for selecting appropriate patients for this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow maxillary expansion: a review of quad-helix therapy during the transitional dentition. Henry, RJ.[2009]

In a study involving 135 patients with unilateral posterior crossbite, both quad-helix and removable expansion plate appliances effectively increased palatal surface area and volume, showing significant improvements compared to untreated patients.

The quad-helix treatment in specialist orthodontic clinics resulted in greater increases in palatal surface and projection area compared to removable expansion plates, indicating that treatment type and setting can influence outcomes, although all treatment groups ultimately achieved similar results to those with normal occlusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional evaluation of forced unilateral posterior crossbite correction in the mixed dentition: a randomized controlled trial. Sollenius, O., Golež, A., Primožič, J., et al.[2022]

In a study involving 72 children with unilateral posterior crossbite, the Quad Helix (QH) appliance caused significantly more tongue pain and appliance chafing on the first day compared to the Rapid Maxillary Expansion (RME) method, indicating a higher initial discomfort with QH.

Despite the differences in discomfort, both appliances resulted in low to moderate pain levels overall, and there was no significant difference in analgesic consumption between the two groups throughout the treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain and discomfort during the first week of maxillary expansion using two different expanders: patient-reported outcomes in a randomized controlled trial. Hansson, S., Josefsson, E., Lindsten, R., et al.[2023]

Both the quad-helix/crib (Q-H/C) appliance and the combination of transpalatal arch, high-pull headgear, and lip bumper (TPA/HG/LB) were effective in treating anterior open bite malocclusion in growing patients, showing similar improvements in dental alignment.

The study involved 50 subjects (22 in the TPA/HG/LB group and 28 in the Q-H/C group) and demonstrated significant reductions in the palatal plane to mandibular plane angle and increases in overbite, indicating that both treatment methods are viable options for correcting this dental issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of two protocols for early treatment of anterior open bite. Mucedero, M., Vitale, M., Franchi, L., et al.[2018]

The quad helix appliance is effective in correcting malocclusions and establishing normal dental arch form, achieving significant results in just 3 to 4 months, which is much faster than traditional methods.

It is particularly beneficial for treating Class II malocclusions and for molar derotation, with its use guided by careful measurements from study casts and cephalometric radiographs to ensure proper expansion of the dental arches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The quad helix appliance. Bench, RW.[2019]

In a study of 34 children with a posterior cross-bite, both a quad-helix and a removable appliance effectively expanded the dental arches, with the quad-helix showing greater basal expansion than the removable appliance.

The quad-helix primarily achieved expansion through buccal translation of the teeth, while the removable appliance relied on buccal tipping, indicating different mechanisms of action for the two treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-dimensional evaluation of dentoskeletal changes after posterior cross-bite correction by quad-helix or removable appliances. Boysen, B., La Cour, K., Athanasiou, AE., et al.[2021]

The Quad Helix (QH) appliance is an effective option for correcting posterior crossbite in children, showing comparable or superior results to other slow maxillary expanders based on a review of 9 studies.

The QH appliance is not only effective but also cost-effective and associated with very few complications, making it a safe choice for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of effectiveness of quad helix appliance with other slow maxillary expanders in children with posterior crossbite: A systematic review. Gidwani, KV., Bendgude, VD., Kokkali, VV., et al.[2022]

In a study of 40 orthodontic patients with a hyperdivergent facial pattern, the quad-helix appliance effectively altered dentofacial morphology, resulting in an upward rotation of the mandible by 2.34 degrees and improved positioning of the maxillary first molars.

The treatment led to significant changes compared to an untreated control group, indicating that the quad-helix appliance is a viable option for addressing maxillary incisor crowding while also reducing the mandibular plane angle in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term treatment effects of the quad-helix appliance on dentofacial morphology of hyperdivergent patients. Endo, S., Yamada, W., Shundo, I., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11546383/

Comparative Experimental Evaluation of Orthodontic ... The aim of this study was to analyze forces and torques generated by different appliances for maxillary expansion.

2. withpower.com withpower.com/trial/phase-overbite-3-2018-f3649

Upper Expansion Appliances for Overbite The quad-helix appliance, a component of the treatment, is effective in expanding the upper jaw in children with a narrow upper arch or crossbite, which can ...

3. orthopracticeus.com orthopracticeus.com/wilson-3d-quad-helix-maxillary-expansion/

The Wilson® 3D® Quad-Helix and maxillary expansion The Wilson 3D Quad-Helix is a slow maxillary expansion appliance with a 3D insertion system, used for molar rotation, torque, and improved arch form.

4. researchgate.net researchgate.net/publication/327839926_Comparison_of_effectiveness_of_quad_helix_appliance_with_other_slow_maxillary_expanders_in_children_with_posterior_crossbite_A_systematic_review

Comparison of effectiveness of quad helix appliance with ... Conclusion: The QH appliance is a viable alternative for the correction of posterior crossbite. The QH appliance is comparable to or even better ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8597322/

Assessment of vertical changes during maxillary expansion ... Overall, both the quad helix expander and the bonded rapid maxillary expander showed minimal vertical changes during palatal expansion treatment.

6. mdpi.com mdpi.com/2076-3417/15/20/11042

Skeletal, Dental, and Nasal Changes After Slow Maxillary ... This study showed statistically significant increases in maxillary inter-molar and inter-premolar widths in patients who were treated with Wilson quad-helix to ...

7. researchgate.net researchgate.net/publication/303293077_Assessment_of_vertical_changes_during_palatal_expansion_using_quad_helix_or_bonded_rapid_palatal_expander

Assessment of vertical changes during palatal expansion ... Overall, both the quad helix expander and the bonded rapid maxillary expander showed minimal vertical changes during palatal expansion treatment.