Sleep BruxismNCT04078074
Occlusal Stabilization Splints and Sleep Disordered Breathing
A study testing Maxillary OSS, Mandibular OSS and Modified farrar splint in people with Sleep Bruxism, run by The University of Texas Health Science Center, Houston.
Trial summary
The purpose of this study is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Sleep Bruxism
- What is being tested?
- Maxillary OSS, Mandibular OSS and Modified farrar splint
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2022to 1 Jul 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with sleep bruxism
- prescribed an occlusal splint
Who cannot join
- Less than 18 years old
- Secondary obstructive sleep apnea diagnosis
- Genetic disease that contributes to possible secondary obstructive sleep apnea
- Patient refuses to sign informed consent document
- Patient does not speak or read English
- More than two missing posterior teeth (excluding third molars)
- Presence of gross malocclusion
About this study
The purpose of this study is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging.
- Conditions
- Sleep Bruxism
- Being tested
- Maxillary OSS, Mandibular OSS, Modified farrar splint
- Medical subject headings
- Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillary OSSDevice
Maxillary OSS will be a night guard for the top teeth. Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo cone beam computed tomography (CBCT) airway imaging with and without splint.
Mandibular OSSDevice
Mandibular OSS will be a night guard for the bottom teeth.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.
Modified farrar splintDevice
Modified farrar splint will be a night guard for the top teeth that positions and maintains the lower jaw in a more forward position.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep. This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.
| Study group | Role | What they receive |
|---|---|---|
| Maxillary OSS | Experimental | Not described Receives: Device: Maxillary OSS |
| Mandibular OSS | Experimental | Not described Receives: Device: Mandibular OSS |
| Modified farrar splint | Experimental | Not described Receives: Device: Modified farrar splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device
Measured: Baseline(without device),with device
Change in pulse as measured by the MediByte device
Measured: Baseline(without device),with device
Change in airflow as measured by the MediByte device
Measured: Baseline(without device),with device
Change in chest plethysmography as measured by the MediByte device
Measured: Baseline(without device),with device
Change in abdomen plethysmography as measured by the MediByte device
Measured: Baseline(without device),with device
Change in masticatory muscle activity as measured by the MediByte device
Measured: Baseline(without device),with device
Secondary outcomes (1)
Change in airway anatomy as measured by CBCT
Measured: Baseline(without device),with device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: Lack of funds
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep BruxismStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Glick, The University of Texas Health Science Center, Houston
- Investigators
- Aaron Glick, DDS, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078074
- Sponsor's protocol ID
- HSC-DB-19-0444
- Status last verified
- Mar 2024
- First submitted
- 1 Sep 2019
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occlusal Stabilization Splints and Sleep Disordered Breathing
- ClinicalTrials.gov ID
- NCT04078074
- Acronym / sponsor ID
- HSC-DB-19-0444
- Conditions
- Sleep Bruxism
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funds
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 4 Sep 2019 (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.
The purpose of this study is to investigate the effects of mandibular occlusal stabilization splint (OSS) and modified farrar splint on sleep bruxism and respiratory indices and the effects of occlusal splints on the airway volume through imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Maxillary OSS | Experimental | Device: Maxillary OSS |
| Mandibular OSS | Experimental | Device: Mandibular OSS |
| Modified farrar splint | Experimental | Device: Modified farrar splint |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosed with sleep bruxism
- prescribed an occlusal splint
Key exclusion criteria (7 listed)
- Less than 18 years old
- Secondary obstructive sleep apnea diagnosis
- Genetic disease that contributes to possible secondary obstructive sleep apnea
- Patient refuses to sign informed consent document
- Patient does not speak or read English
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 |
|---|---|---|
| Maxillary OSSMaxillary OSS will be a night guard for the top teeth. Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo cone beam computed tomography (CBCT) airway imaging with and without splint. | Device | Maxillary OSS |
| Mandibular OSSMandibular OSS will be a night guard for the bottom teeth.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint. | Device | Mandibular OSS |
| Modified farrar splintModified farrar splint will be a night guard for the top teeth that positions and maintains the lower jaw in a more forward position.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep. This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint. | Device | Modified farrar splint |
Primary outcome
Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device
Time frame: Baseline(without device),with device
Change in pulse as measured by the MediByte device
Time frame: Baseline(without device),with device
Change in airflow as measured by the MediByte device
Time frame: Baseline(without device),with device
Change in chest plethysmography as measured by the MediByte device
Time frame: Baseline(without device),with device
Change in abdomen plethysmography as measured by the MediByte device
Time frame: Baseline(without device),with device
Change in masticatory muscle activity as measured by the MediByte device
Time frame: Baseline(without device),with device
1 secondary outcome
Change in airway anatomy as measured by CBCT
Time frame: Baseline(without device),with device
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Aaron Glick, DDS principal investigator
The University of Texas Health Science Center, Houston
Questions about this trial
What is this clinical trial studying?
A study testing Maxillary OSS, Mandibular OSS and Modified farrar splint in people with Sleep Bruxism, run by The University of Texas Health Science Center, Houston.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in peripheral capillary oxygen saturation (SpO2) as measured by the MediByte device (time frame: Baseline(without device),with device). The study lists 6 primary outcomes in all. 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 15 Mar 2024.