Obstructive Sleep ApneaTACONCT03341130
Determinants of Tooth Movement in Oral Appliance Treatment of OSA.
A study testing Mandibular Repositioning Splint and Mandibular Advancement Oral Appliance in people with Obstructive Sleep Apnea, run by University of British Columbia at 1 site in Canada.
Trial summary
Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately 10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for OSA, however, long term use has shown to lead to changes in teeth positioning and jaw alignment (bite changes), which has resulted in… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Mandibular Repositioning Splint and Mandibular Advancement Oral Appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteCanada
- Study dates
- 22 Aug 2018to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment naive (have never used an oral appliance as treatment for OSA);
- Age 25 - 65 years old, who are able to freely provide informed consent;
- Body Mass Index (BMI) ≤ 35;
- 8 or more teeth per arch to support treatment with OAM;
- Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years *OR*
- Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with level III portable sleep test *OR*
- Oxygen Desaturation Index (ODI) ≥ 10
Who cannot join
- Extensive periodontal disease with significant tooth mobility;
- Inability to protrude jaw;
- Insufficient vertical opening to accommodate treatment with OAM;
- Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
- Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
- Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
Show all 10Show fewer
- Any history of angina, myocardial infarction or stroke;
- Any history of major depressive disorder along with current moderate-severe disease;
- Active cancer management (unless in remission for more than 1 year);
- Known renal failure (with need for dialysis)
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6T 1Z3
Benjamin T Pliska, DDS, 604-822-7237, pliska@dentistry.ubc.ca
Eleanor F Cawthorne, BSc, 604-827-0690, ecawthorne@dentistry.ubc.ca
About this study
Official title: Determinants of Occlusal Changes in Oral Appliance Treatment of OSA - A Randomized Controlled Trial
Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately 10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for OSA, however, long term use has shown to lead to changes in teeth positioning and jaw alignment (bite changes), which has resulted in some patients stopping treatment.
It is becoming common clinical practice for doctors to prescribe the use of repositioning splints to help reduce the bite changes associated with using OAM. However, this has not been studied in a clinical trial.
Read more
This study will compare the bite changes between patients using OAM alone against patients using a morning repositioning splint in addition to OAM. Other variables, such as oral health, the size of mandibular advancement, and treatment adherence will also be measured to determine if they have an effect on the bite changes associated with OAM use.
By understanding the key the factors that influence the bite changes associated with OAM use and potentially validating a technique to reduce these changes, this study will improve the clinical practice of Dental Sleep Medicine, leading to improved health outcomes for OSA patients.
Read the detailed description
Mandibular advancement oral appliances (OAM) are an effective treatment for obstructive sleep apnea (OSA). However, prolonged OAM treatment leads to significant changes in occlusion for the majority of patients. As such it is not uncommon to find changes in occlusion and the resulting decrease in quality of life in long-term users of oral appliances to be cited as a reason for discontinuing OAM treatment. Understanding the determinants of occlusal changes and clinical strategies to minimize or prevent them are essential to the practice of Dental Sleep Medicine, where treatment success is predicated on high levels of adherence.
Morning Repositioners or alternative oral appliances/splints that counteract the muscle splinting of the mandible in a forward postured position have been advocated by some practitioners as a means of minimizing the occlusal changes associated with OAM treatment. However, this has not been studied in a prospective clinical trial.
The proposed study is a single-blinded prospective randomized controlled trial at three clinical centers, with the specific aim of assessing the effectiveness of mandibular repositioning splint use on minimizing the occlusal changes associated with OAM treatment. Secondary aims include also determining the effects of periodontal disease, treatment adherence, and magnitude of mandibular advancement on occlusal changes associated with OAM treatment.
90 OSA patients will receive OAM treatment following standard practices. A titration period of two months will be used to adjust the position of mandibular advancement for each patient, which will involve clinical follow-up visits at a minimum of 1 week, 1 month and 2 months after initiation of OAM treatment. Each participant will be randomly assigned to either the treatment or control group. The treatment group will receive a mandibular repositioning splint to wear for a minimum of 1 hour in the mornings following removal of OAM. A positive control group will receive no additional splint, and but will be managed using standard practices, including jaw stretching exercises as needed. A second negative control group consisting of 15 healthy adults not undergoing any oral appliance treatment will also be included.
Prior to receiving treatment, participants will undergo a baseline assessment where demographic, anthropometric, and specific periodontal health data will be collected. All measurements will be repeated at a minimum of 18 and 36 months after appliance insertion, with routine follow-up appointments and adherence data collected every six months.
To directly address the primary aim of this study, occlusal variables will be measured by a combination of methods including analysis of digitized dental models, cephalometric analysis and intra-oral radiography bone level measurements. Secondary outcome variables to assess the effectiveness of morning mandibular repositioning splint therapy will include average OAM adherence (hours/night), quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ), and change in mandibular incisor root length and attachment loss. Adherence will be measured by compliance monitors embedded in the oral appliance and mandibular repositioning splints.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Mandibular Repositioning Splint, Mandibular Advancement Oral Appliance
- Keywords
- OSA, Mandibular Advancement Splint, Oral Appliance, Treatment, Repositioning Splint
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular Repositioning SplintDevice
Also called Morning Repositioner, Morning Aligner
The Morning Repositioner is a hands-free bite deprogrammer designed to help return the patient's jaw back to its pre-treatment centric position.
Mandibular Advancement Oral ApplianceDevice
Also called OAM, MAS
Mandibular Advancement Oral Appliances are dental splints used to keep the jaw in an advanced position, opening the upper airway during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Device: Mandibular Repositioning Splint; Device: Mandibular Advancement Oral Appliance |
| Positive Control Group | Experimental | 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. Receives: Device: Mandibular Advancement Oral Appliance |
| Negative Control Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Overjet
The change in the extent of horizontal (anterior-posterior) overlap of the maxillary central incisors over the mandibular central incisors, measured from digital dental model analysis.
Measured: Data collected at 0, 18 and 36 months after appliance insertion.
Secondary outcomes (9)
Treatment Adherence
Adherence will be measured by the DentiTrac smart chip (Braebon Medical Corporation, Kanata, Canada) embedded in the oral appliance and mandibular repositioning splints. The adherence will be measured in hours per night and nights per week.
Measured: Data collected every 6 months after treatment commencement, up to 36 months.
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
FOSQ-10 measures functional status and difficulty in performing everyday activities via 10 questions. The range of scores for any question is from 1 to 4. There is also a 0 score option for participants who do not engage in a particular activity for other reasons, in which case the question will be excluded. There are 5 subscales that measure: general productivity, activity level, vigilance, social outcomes, and intimacy and sexual relationships. To obtain the total score, a mean-weighted item score is computed for those subscales with more than one item. To calculate a mean-weighted item score calculate the mean of the answered items with responses > 1 for each subscale. The total score is then derived by calculating the mean of the subscale scores and multiplying that mean by five. Total score ranges between 5 and 20. Higher scores indicate better functional status.
Measured: Data collected at 0, 1, 2, 18 and 36 months after appliance insertion.
Daytime Sleepiness
Evaluation of OSA specific fatigue using Epworth Sleepiness Scale (ESS) questionnaire. ESS measures daytime sleepiness via 8 questions that ask about daytime sleepiness during common everyday conditions. The potential range of scores for any questions is from 0 to 3. Higher values represent worse outcomes. Their are no subscales for ESS. The answers to the questions are all summed up. Total score ranges between 0 and 24. A score above 10 indicates daytime sleepiness with higher scores indicating more sleepiness.
Measured: Data collected at 0, 1, 2, 18 and 36 months after appliance insertion.
Change in Overbite
Using digital dental model analysis to evaluate the change in the extent of vertical (superior-inferior) overlap of the maxillary central incisors over the mandibular central incisors, measured relative to the incisal edges.
Measured: Data collected at 0, 18 and 36 months after appliance insertion.
Dental Crowding
Changes in dental crowding, measured by digital dental model analysis.
Measured: Data collected at 0, 18 and 36 months after appliance insertion.
Intermolar Distance
Changes in distance between molars, measured by digital dental model analysis.
Measured: Data collected at 0, 18 and 36 months after appliance insertion.
Intercanine Distance
Changes in distance between canines, measured by digital dental model analysis.
Measured: Data collected at 0, 18 and 36 months after appliance insertion.
Posterior Occlusal Changes
Changes in the number of posterior teeth with open occlusal contacts, measured from digital dental model analysis.
Measured: Data collected at 0, 18 and 36 months after appliance insertion.
Anterior Occlusal Changes
Change in the number of anterior teeth in crossbite, measured from digital dental model analysis.
Measured: Data collected at 0, 18 and 36 months after appliance insertion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study start22 Aug 2018
- Primary completionJul 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, Laval University
- Responsible party
- Principal investigator, Benjamin Pliska, University of British Columbia
- Investigators
- Benjamin T Pliska, DDS, Principal investigator, University British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341130
- Sponsor's protocol ID
- F17-00320
- Acronym
- TACO
- Status last verified
- Sep 2023
- First submitted
- 2 Nov 2017
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Occlusal Changes in Oral Appliance Treatment of OSA - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03341130
- Acronym / sponsor ID
- TACO / F17-00320
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, Mandibular Advancement Splint, Oral Appliance, Treatment, Repositioning Splint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Université de Montréal, Laval University
- Study start
- 22 Aug 2018 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately 10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for OSA, however, long term use has shown to lead to changes in teeth positioning and jaw alignment (bite changes), which has resulted in some patients stopping treatment.
It is becoming common clinical practice for doctors to prescribe the use of repositioning splints to help reduce the bite changes associated with using OAM. However, this has not been studied in a clinical trial.
This study will compare the bite changes between patients using OAM alone against patients using a morning repositioning splint in addition to OAM. Other variables, such as oral health, the size of mandibular advancement, and treatment adherence will also be measured to determine if they have an effect on the bite changes associated with OAM use.
By understanding the key the factors that influence the bite changes associated with OAM use and potentially validating a technique to reduce these changes, this study will improve the clinical practice of Dental Sleep Medicine, leading to improved health outcomes for OSA patients.
Detailed description
Mandibular advancement oral appliances (OAM) are an effective treatment for obstructive sleep apnea (OSA). However, prolonged OAM treatment leads to significant changes in occlusion for the majority of patients. As such it is not uncommon to find changes in occlusion and the resulting decrease in quality of life in long-term users of oral appliances to be cited as a reason for discontinuing OAM treatment. Understanding the determinants of occlusal changes and clinical strategies to minimize or prevent them are essential to the practice of Dental Sleep Medicine, where treatment success is predicated on high levels of adherence.
Morning Repositioners or alternative oral appliances/splints that counteract the muscle splinting of the mandible in a forward postured position have been advocated by some practitioners as a means of minimizing the occlusal changes associated with OAM treatment. However, this has not been studied in a prospective clinical trial.
The proposed study is a single-blinded prospective randomized controlled trial at three clinical centers, with the specific aim of assessing the effectiveness of mandibular repositioning splint use on minimizing the occlusal changes associated with OAM treatment. Secondary aims include also determining the effects of periodontal disease, treatment adherence, and magnitude of mandibular advancement on occlusal changes associated with OAM treatment.
90 OSA patients will receive OAM treatment following standard practices. A titration period of two months will be used to adjust the position of mandibular advancement for each patient, which will involve clinical follow-up visits at a minimum of 1 week, 1 month and 2 months after initiation of OAM treatment. Each participant will be randomly assigned to either the treatment or control group. The treatment group will receive a mandibular repositioning splint to wear for a minimum of 1 hour in the mornings following removal of OAM. A positive control group will receive no additional splint, and but will be managed using standard practices, including jaw stretching exercises as needed. A second negative control group consisting of 15 healthy adults not undergoing any oral appliance treatment will also be included.
Prior to receiving treatment, participants will undergo a baseline assessment where demographic, anthropometric, and specific periodontal health data will be collected. All measurements will be repeated at a minimum of 18 and 36 months after appliance insertion, with routine follow-up appointments and adherence data collected every six months.
To directly address the primary aim of this study, occlusal variables will be measured by a combination of methods including analysis of digitized dental models, cephalometric analysis and intra-oral radiography bone level measurements. Secondary outcome variables to assess the effectiveness of morning mandibular repositioning splint therapy will include average OAM adherence (hours/night), quality of life (Functional Outcomes of Sleep Questionnaire, FOSQ), and change in mandibular incisor root length and attachment loss. Adherence will be measured by compliance monitors embedded in the oral appliance and mandibular repositioning splints.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Device: Mandibular Repositioning Splint, Device: Mandibular Advancement Oral ApplianceThe 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. |
| Positive Control Group | Experimental | Device: Mandibular Advancement Oral ApplianceThe 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. |
| Negative Control Group | No 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Treatment naive (have never used an oral appliance as treatment for OSA);
- Age 25 - 65 years old, who are able to freely provide informed consent;
- Body Mass Index (BMI) ≤ 35;
- 8 or more teeth per arch to support treatment with OAM;
- Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years *OR*
Key exclusion criteria (10 listed)
- Extensive periodontal disease with significant tooth mobility;
- Inability to protrude jaw;
- Insufficient vertical opening to accommodate treatment with OAM;
- Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
- Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mandibular Repositioning SplintAlso: Morning Repositioner, Morning AlignerThe Morning Repositioner is a hands-free bite deprogrammer designed to help return the patient's jaw back to its pre-treatment centric position. | Device | Treatment Group |
| Mandibular Advancement Oral ApplianceAlso: OAM, MASMandibular Advancement Oral Appliances are dental splints used to keep the jaw in an advanced position, opening the upper airway during sleep. | Device | Positive Control Group, Treatment Group |
Primary outcome
Change in Overjet
Time frame: Data collected at 0, 18 and 36 months after appliance insertion.
The change in the extent of horizontal (anterior-posterior) overlap of the maxillary central incisors over the mandibular central incisors, measured from digital dental model analysis.
9 secondary outcomes
Treatment Adherence
Time frame: Data collected every 6 months after treatment commencement, up to 36 months.
Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)
Time frame: Data collected at 0, 1, 2, 18 and 36 months after appliance insertion.
Daytime Sleepiness
Time frame: Data collected at 0, 1, 2, 18 and 36 months after appliance insertion.
Change in Overbite
Time frame: Data collected at 0, 18 and 36 months after appliance insertion.
Dental Crowding
Time frame: Data collected at 0, 18 and 36 months after appliance insertion.
Intermolar Distance
Time frame: Data collected at 0, 18 and 36 months after appliance insertion.
Intercanine Distance
Time frame: Data collected at 0, 18 and 36 months after appliance insertion.
Posterior Occlusal Changes
Time frame: Data collected at 0, 18 and 36 months after appliance insertion.
Anterior Occlusal Changes
Time frame: Data collected at 0, 18 and 36 months after appliance insertion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin T Pliska, DDS principal investigator
University British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular Repositioning Splint and Mandibular Advancement Oral Appliance in people with Obstructive Sleep Apnea, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin T Pliska, DDS (604-822-7237, pliska@dentistry.ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overjet (time frame: Data collected at 0, 18 and 36 months after appliance insertion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.