Orthodontic Treatment for Sleep Apnea

Overseen By Manuel Lagravere, PHD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Syndromic, Previous ortho, Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

Trial Summary

What is the purpose of this trial?

Breathing is a crucial function for everyone. Breathing impairment in children could lead to behavioral and cognitive problems at least. But what if orthodontic treatment could help those patients to breathe better, with less effort? This research proposal aims to find out if the increase in the upper airway volume seen in some research results can be related to a decrease in respiratory effort and an improvement in the breathing capacity of those patients. In other words, if a tube shape is changed or if a tube is enlarged, would the airflow passing inside the tube change in velocity? Or would there be more air? Therefore, investigating the pressure/airflow, volume/lumen relation and its possible changes after mandibular repositioning and maxillary expansion in children will lead to a better understanding of how orthodontics could potentially affect the upper airway. Previous studies have reported a link between mandibular advancement appliances and maxillary appliances to an increase in the upper airway volume. However, more studies are needed to evaluate the relationship between the changes in the upper airway volume and actual airflow and respiratory capability. The airway volume measurement is important to, preliminary, state if there is an increase in the upper airway after orthodontic treatment. However a change in shape, even with the same volume, can affect the pressure and airflow. In this sense, the pressure drop analysis will allow an answer to those questions

Do I need to stop my current medications for this trial?

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

Is orthodontic treatment for sleep apnea using devices like the Hyrax expander generally safe?

The research articles focus on the effects and changes caused by the Hyrax expander and similar devices, but they do not provide specific safety data. However, these devices are commonly used in orthodontics, suggesting they are generally considered safe for correcting dental issues. ^{1 2 3 4 5}

How does the orthodontic treatment using Hyrax and Twin block appliances differ from other treatments for sleep apnea?

This treatment is unique because it combines two orthodontic devices, the Hyrax expander and the Twin block appliance, to address sleep apnea by expanding the upper jaw and advancing the lower jaw, which can improve airway space. This approach is different from other treatments like CPAP (continuous positive airway pressure) machines, as it focuses on structural changes in the mouth and jaw to alleviate symptoms. ^{1 2 5 6 7}

Research Team

Silvia G Capenakas, MSc

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for children aged 8-14 with a specific dental misalignment (skeletal class II division 1 malocclusion) and narrowed upper jaw. It's not open to those who've had previous orthodontic treatment, aren't likely to follow the study rules, have serious dental problems like cavities or bad hygiene, or have genetic syndromes.

Inclusion Criteria

My child is 8-14 years old with a specific type of jaw misalignment and a narrow upper jaw.

Exclusion Criteria

I have severe dental problems.

Not following the study rules.

You have had previous orthodontic treatment.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part I

Participants undergo either maxillary expansion or mandibular advancement depending on group allocation

Varies by group

Multiple visits for orthodontic adjustments

Treatment Part II

Participants undergo the second phase of treatment: either mandibular advancement or maxillary expansion

Varies by group

Multiple visits for orthodontic adjustments

Follow-up

Participants are monitored for changes in airway volume, airflow, and skeletal/dental changes

1.5 years

In-home PSG tests and CBCT scans at specified intervals

Treatment Details

Interventions

• Hyrax then Twin block
• Twin block then Hyrax

Trial Overview The study tests whether two orthodontic treatments can improve breathing in kids by changing the shape and size of their airways. One group will first use a Hyrax device then switch to a Twin block brace; another group does this in reverse order.

Participant Groups

Group I: Twin Block then Hyrax Experimental Treatment 1 Intervention

Patients will undergo mandibular advancement prior to maxillary expansion using Twin block prior to Hyrax

Group II: Hyrax then Twin block Experimental Treatment 1 Intervention

Patients will undergo maxillary expansion prior to mandibular advancement using Hyrax prior to Twin block

Group III: Control Active Control 1 Intervention

Patients will wait 1,5 years before the start of treatment

Hyrax then Twin block is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Hyrax appliance for:

• Orthodontic correction
• Sleep apnea treatment
• Respiratory improvement

Approved in United States as Twin block appliance for:

• Orthodontic correction
• Sleep apnea treatment
• Respiratory improvement

Approved in Canada as Rapid Maxillary Expansion (RME) device for:

• Orthodontic correction
• Sleep apnea treatment
• Respiratory improvement

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Findings from Research

Both the Hyrax and Haas expanders effectively increased maxillary transverse dimensions in children with crossbite, indicating their efficacy in correcting this dental issue.

The Hyrax expander resulted in a significantly greater increase in lingual bone thickness compared to the Haas expander, although this difference may not be clinically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tomographic evaluation of dentoskeletal effects of rapid maxillary expansion using Haas and Hyrax palatal expanders in children: A randomized clinical trial. Araújo, MC., Bocato, JR., Oltramari, PV., et al.[2022]

In a study of 63 children aged 7 to 16 years, rapid maxillary expansion (RME) using the modified Hyrax appliance resulted in significant increases in upper interdental distances, with an average increase of 5.85 mm in the upper intermolar distance.

The study found a direct relationship between the screw opening of the appliance and the changes in interdental distances, indicating that for every millimeter the screw was opened, the upper intermolar distance increased by 0.94 mm, demonstrating the efficacy of RME in correcting maxillary atresia and crossbites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the relationship between the upper and lower arch changes with the opening of the expanding screw after the rapid maxillary expansion. Santos, P., Vale, T., Moreira, J., et al.[2021]

Rapid maxillary expansion (RME) using Hyrax appliances resulted in a significant increase in the width of the maxillary arch, with an average expansion of approximately 4.8 mm for premolars and 4.7 mm for molars in a study of 28 patients aged 13 to 20 years.

The procedure caused notable tipping of the palatal roots of teeth and a decrease in buccal bone thickness, indicating a need for careful monitoring of inflammation to prevent potential periodontal issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cone beam computed tomography analysis of dentoalveolar changes immediately after maxillary expansion. Domann, CE., Kau, CH., English, JD., et al.[2021]

Rapid maxillary expansion (RME) using the Hyrax expander significantly increased the palatal surface area and intermolar width in 14 growing patients, with a mean age of 11.7 years, as measured by cone beam computed tomography (CBCT).

After a 6-month retention period, the increases in palatal area and width remained stable, indicating that RME is an effective treatment for maxillary atresia without causing vertical changes in the palate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of palate area before and after rapid maxillary expansion, using cone-beam computed tomography. Bruder, C., Ortolani, CLF., Lima, TA., et al.[2020]

In a study involving 42 patients aged 11-14, both the Hyrax and Hybrid Hyrax appliances used for rapid maxillary expansion caused low-intensity pain and discomfort, with no significant differences in pain levels between the two types of appliances.

The study found that female patients reported higher levels of pain and functional limitation compared to males, indicating a greater sensitivity to the discomfort caused by the rapid maxillary expansion process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term assessment of pain and discomfort during rapid maxillary expansion with tooth-bone-borne and tooth-borne appliances: randomized clinical trial. Pasqua, BPM., André, CB., Paiva, JB., et al.[2023]

A seven-year-old boy with obstructive sleep apnea showed significant improvement after undergoing rapid maxillary expansion (RME), with his apnea-hypopnea index (IAH) decreasing from 2.8 events per hour to 0.5 events per hour after six months.

The study utilized various diagnostic tests, including polysomnography and the OSA-18 quality of life questionnaire, indicating that RME can effectively enhance both sleep quality and overall quality of life in children with OSA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid maxillary expansion in patient with obstructive sleep apnea: case report. Bariani, RC., Badreddine, FR., Yamamoto, LH., et al.[2022]

Both the hyrax and T4K appliances effectively advance the maxilla in mouth-breathing patients with Class II malocclusion, based on a study of 28 patients treated between June 2015 and May 2019.

The T4K appliance showed greater improvements in mandibular length and skeletal changes compared to the hyrax, suggesting it may provide better overall sagittal correction, although it may also lead to more dental compensation rather than skeletal remodeling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of rapid maxillary expansion and pre-fabricated myofunctional appliance for the management of mouth breathers with Class II malocclusion. Zhang, X., He, JM., Zheng, WY.[2021]

References

1. Spain pubmed.ncbi.nlm.nih.gov

Tomographic evaluation of dentoskeletal effects of rapid maxillary expansion using Haas and Hyrax palatal expanders in children: A randomized clinical trial. [2022]

2. Belgium pubmed.ncbi.nlm.nih.gov

Assessment of the relationship between the upper and lower arch changes with the opening of the expanding screw after the rapid maxillary expansion. [2021]

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

Cone beam computed tomography analysis of dentoalveolar changes immediately after maxillary expansion. [2021]

4. Brazil pubmed.ncbi.nlm.nih.gov

Evaluation of palate area before and after rapid maxillary expansion, using cone-beam computed tomography. [2020]

5. Brazil pubmed.ncbi.nlm.nih.gov

Short-term assessment of pain and discomfort during rapid maxillary expansion with tooth-bone-borne and tooth-borne appliances: randomized clinical trial. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Rapid maxillary expansion in patient with obstructive sleep apnea: case report. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Comparison of rapid maxillary expansion and pre-fabricated myofunctional appliance for the management of mouth breathers with Class II malocclusion. [2021]