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

Trial Summary

What is the purpose of this trial?

Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw expansion appliance. Previous research showed that the use of similar appliances can lead to lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.

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 data supports the effectiveness of the treatment Upper arch Wilson quadhelex appliance 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 indirectly help with overbite correction by improving jaw alignment. ^{1 2 3 4 5}

Is the quad helix appliance safe for humans?

The quad helix appliance is commonly used in children for dental issues like crossbite and is generally considered safe, though some discomfort may occur during the first week of use. ^{1 4 5 6 7}

How does the Upper arch Wilson quadhelex appliance treatment for overbite differ from other treatments?

The Upper arch Wilson quadhelex appliance is unique because it provides slow and controlled expansion of the upper jaw, which is beneficial for children with developing teeth. Unlike rapid expansion methods that can cause discomfort, this appliance uses gentle forces to gradually widen the dental arch, making it a preferred choice for treating conditions like posterior crossbite in growing children. ^{1 3 4 5 8}

Eligibility Criteria

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

I have received other orthodontic treatments.

History of growth problems (craniofacial syndromes, etc.)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Australia pubmed.ncbi.nlm.nih.gov

Short-term treatment effects of the quad-helix appliance on dentofacial morphology of hyperdivergent patients. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Three-dimensional evaluation of forced unilateral posterior crossbite correction in the mixed dentition: a randomized controlled trial. [2022]

4. England 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. [2023]

5. India 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Comparisons of two protocols for early treatment of anterior open bite. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

The quad helix appliance. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Three-dimensional evaluation of dentoskeletal changes after posterior cross-bite correction by quad-helix or removable appliances. [2021]