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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether orthodontic treatments can help children with sleep apnea breathe more easily. It examines two treatment sequences: first, expanding the upper jaw with a Hyrax device (a type of orthodontic appliance) and then using a Twin Block to move the lower jaw forward, or vice versa. The goal is to determine if these treatments can increase airway size and improve airflow. Children who might be suitable for this trial typically have jaw alignment issues, specifically a condition called skeletal class II division 1 malocclusion with a narrow upper jaw. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance treatment options for children with sleep apnea.

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.

What prior data suggests that these orthodontic treatments are safe for improving breathing in children?

Research has shown that orthodontic treatments like the Hyrax expander and Twin block appliance are generally safe for children. These devices can help with sleep apnea by enlarging the airway. Specifically, the Hyrax expander can significantly increase the size of the nasal cavity and upper airway, potentially improving breathing.

While specific safety data isn't mentioned, these treatments are widely used and usually well-tolerated. Serious side effects are not commonly reported in research. Any discomfort is typically mild and temporary, such as slight soreness or pain from adjustments.

Overall, these orthodontic treatments appear to be a safe option for treating sleep apnea in children. However, discussing any concerns with a healthcare provider before starting treatment is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these orthodontic treatments for sleep apnea because they offer a novel approach by using dental appliances to address airway issues. Unlike standard treatments like CPAP machines, which can be cumbersome and uncomfortable, the Hyrax and Twin Block devices aim to physically expand and reposition the jaw and palate, potentially improving airflow naturally. The unique aspect of these treatments is their focus on orthodontic restructuring, which might provide a more permanent solution by altering the jaw's alignment and structure, rather than just managing symptoms. These methods could offer new hope for patients seeking less invasive and more enduring relief from sleep apnea.

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

Research shows that orthodontic treatments like Hyrax and Twin block appliances can help children with sleep apnea breathe better. In this trial, participants will join different treatment arms to evaluate these approaches. One arm involves maxillary expansion before mandibular advancement using the Hyrax appliance, followed by the Twin block appliance. Another arm involves mandibular advancement before maxillary expansion using the Twin block appliance, followed by the Hyrax appliance. Studies have found that these treatments can enlarge the upper airway, improving airflow and reducing breathing problems during sleep. For instance, using a Twin block appliance has been linked to better sleep quality and fewer breathing interruptions. Similarly, widening the upper jaw, known as rapid maxillary expansion, has been reported to improve breathing. Together, these changes can significantly help manage sleep apnea symptoms. ^{1 4 5 6 7}

Who Is on the Research Team?

Silvia G Capenakas, MSc

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11514814/

Effectiveness of mandibular advancement orthodontic ... The current review aims to explore the evidence regarding the effectiveness of mandibular advancement orthodontic appliances with maxillary ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12224399/

Effects of rapid maxillary expansion and functional orthodontic ... [38] observed a significant improvement in sleep quality after the use of the Twin-Block appliance by improving AHI and increase of the volume ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222001435

Effect of orthopedic and functional orthodontic treatment in ... Cecili, et al. Rapid maxillary expansion outcomes in treatment of obstructive sleep apnea in children. Sleep Med, 16 (2015), pp. 709-716, 10.1016/j.sleep.

4. sleepmedres.org sleepmedres.org/upload/pdf/smr-2024-02124.pdf

SMR Sleep Med Res 2024;15(2):113-123 Patients were treated with customized fixed intraoral rapid maxillary expansion with a twin-block mandibular advancement appliance (Fig. 1A) ...

5. mdpi.com mdpi.com/2077-0383/14/18/6565

Assessment of the Effect of Rapid Maxillary Expansion on ... This systematic review assessed the effectiveness of rapid maxillary expansion (RME) in improving both the structural and functional parameters of nasal ...

6. withpower.com withpower.com/trial/phase-airway-obstruction-1-2020-8aa5d

Orthodontic Treatment for Sleep Apnea 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, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11544907/

Effects of Hyrax Maxillary Expander on Nasal Cavity and ... A significant increase in nasopharynx volume was observed after rapid maxillary expansion (RME) by Hyrax maxillary expander.