Orthodontic Treatment for Sleep Apnea

Recruiting in Palo Alto (17 mi)

Overseen by Silvia G Capenakas, MSc

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alberta

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

No Placebo Group

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.

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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.

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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.

Trial 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

Participant Groups

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.

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, Australia 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

🇦🇺 Approved in Australia as Mandibular Advancement Device for:

• Orthodontic correction
• Sleep apnea treatment
• Respiratory improvement

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Alberta Edmonton, Canada

Who Is Running the Clinical Trial?

University of Alberta Lead Sponsor

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] Rapid maxillary expansion (RME) is a usual procedure for correcting the transversal maxillary deficiency. Among the most used appliances are the Haas type (tooth-tissue-borne) and Hyrax (tooth-borne) whose main difference is the design. This study aimed to evaluate the dentoskeletal effects of RME using two different expanders in children.

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] The purpose of this study is to assess the relationship of the upper and lower arch dimension changes after the rapid maxillary expansion (RME) with the screw opening of the modified Hyrax® type appliance.

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

Cone beam computed tomography analysis of dentoalveolar changes immediately after maxillary expansion. [2021] Rapid maxillary expansion (RME) splits the midpalatal suture to correct maxillary transverse discrepancies and increase the arch perimeter. The goal of this paper is to evaluate the immediate effects of RME with Hyrax appliances on the dentoalveolar complex using cone beam computed tomography (CBCT).

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

Evaluation of palate area before and after rapid maxillary expansion, using cone-beam computed tomography. [2020] The aim of this study was to estimate the changes in the palate area after rapid maxillary expansion (RME) with the Hyrax expander in growing subjects, using cone beam computed tomography (CBCT).

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] The aim of this randomized clinical trial was to evaluate and compare, during the first week of rapid maxillary expansion (RME), the impact caused by two types of appliances: Hyrax and Hybrid Hyrax.

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

Rapid maxillary expansion in patient with obstructive sleep apnea: case report. [2022] The aim of this case report was to evaluate the polysomnography indices, air space in the oropharyngeal region and quality of life scores using the OSA-18 questionnaire in a patient diagnosed with obstructive sleep apnea before and after rapid maxillary expansion (RME). It is a case report with a male patient, seven years old, with maxillary hypoplasia, who underwent adenotonsillectomy surgery two years ago, had restless sleep, snore more than five times a week. Pre- and post-treatment diagnostic tests were performed, including nasofibroscopy, polysomnography, computed tomography, orthodontic records and the OSA-18 quality of life questionnaire. The treatment consisted of RME with Hyrax maxillary expander. After six months, the exams were redone. The polysomnographic record before treatment: IAH 2.8/h, after treatment 0.5/h. We concluded that rapid maxillary expansion (RME) in children with OSA appears to be an effective treatment.

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] Pre-fabricated myofunctional appliances and rapid maxillary expansion (RME) has been used for the treatment of mouth-breathers with Class-II malocclusion. This study aimed to compare the treatment effects of hyrax and pre-fabricated myofunctional appliance (T4K) for the management of mouth breathers with Class II Malocclusion in mixed dentition stage.