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Oral Appliances for Obstructive Sleep Apnea (TACO Trial)

N/A

Recruiting

Led By Benjamin T Pliska, DDS

Research Sponsored by University of British Columbia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

8 or more teeth per arch to support treatment with OAM

Treatment naive (have never used an oral appliance as treatment for OSA)

Must not have

Inability to protrude jaw

Known renal failure (with need for dialysis)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up data collected at 0, 18 and 36 months after appliance insertion.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the teeth positioning changes of people using a mouthpiece for sleep apnea with and without a morning mouth guard.

Who is the study for?

This trial is for adults aged 25-65 with mild to moderate Obstructive Sleep Apnea, documented by specific sleep tests. Participants must have a BMI ≤ 35, at least 8 teeth per arch, and no prior OAM treatment for OSA. Exclusions include severe dental or jaw issues, pregnancy, major depression with current severe disease, certain heart conditions, stroke history, and active cancer unless in remission.

What is being tested?

The study examines if using a morning repositioning splint along with an oral appliance (OAM) reduces bite changes compared to using just the OAM in treating sleep apnea. It will also assess how factors like oral health and the extent of mandibular advancement affect these potential changes.

What are the potential side effects?

Potential side effects may include discomfort from wearing the appliances, possible soreness in the jaw muscles or temporomandibular joint (TMJ), saliva buildup or dry mouth while sleeping.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least 8 teeth in each jaw.

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I have never used an oral appliance for sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot move my jaw forward.

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I have kidney failure and need dialysis.

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I have a history of heart issues like angina, heart attack, or stroke.

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I have severe gum disease with loose teeth.

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I have a history of major depression and it is currently moderate to severe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ data collected at 0, 18 and 36 months after appliance insertion.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~data collected at 0, 18 and 36 months after appliance insertion.

This trial's timeline: 3 weeks for screening, Varies for treatment, and data collected at 0, 18 and 36 months after appliance insertion. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Overjet

Secondary study objectives

Anterior Occlusal Changes

Change in Overbite

Daytime Sleepiness

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Treatment GroupExperimental Treatment2 Interventions

The treatment group will will be treated a mandibular advancement oral appliance following standard practices. The treatment group will also receive a mandibular repositioning splint to wear in the mornings for a minimum of 1 hour following removal of their mandibular advancement oral appliance, in an effort to reduce the side effects resulting from use of the mandibular advancement oral appliance.

Group II: Positive Control GroupExperimental Treatment1 Intervention

The positive control group will will be treated a mandibular advancement oral appliance following standard practices. The positive control group will not receive any additional oral appliances. Side effects resulting from use of the mandibular advancement oral appliance will be managed using standard practices, including jaw stretching exercises as needed for comfort.

Group III: Negative Control GroupActive Control1 Intervention

The negative control group is comprised of 15 healthy individuals recruited specifically from faculty members at the UBC Faculty of Dentistry. This group will undergo the same clinical data collection as the treatment group and the negative control group but will not receive any treatment.

0 / 7Eligibility criteria met