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Occlusal Stabilization Splints for Teeth Grinding

PL
AG
Overseen ByAaron Glick, DDS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how different types of mouth splints affect sleep bruxism (teeth grinding during sleep) and breathing problems. Researchers are using three types of splints: Mandibular OSS, Maxillary OSS, and a Modified Farrar Splint, to assess their impact on teeth grinding and airways. They also aim to observe changes in airway volume through imaging. Individuals who grind their teeth at night and already use a mouth splint might be suitable for this trial. As an unphased study, this trial offers a unique opportunity to contribute to understanding how different splints can improve sleep quality and breathing.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these occlusal splints are safe for treating sleep bruxism and respiratory indices?

Research has shown that occlusal stabilization splints, such as the mandibular and maxillary OSS, are generally safe for use. Studies indicate that the mandibular OSS is unlikely to cause allergic reactions, as it lacks materials that typically trigger allergies.

The maxillary OSS is also considered safe. Research has found no major issues, such as bleeding or mouth damage, when similar procedures are performed, suggesting the maxillary OSS is safe as well.

The modified Farrar splint, another type of occlusal splint, is also regarded as safe. Some individuals have noticed minor changes in how their teeth fit together, but these changes are usually manageable.

Overall, these splints are well-tolerated, with few reports of serious side effects, making them a safe option for those considering participation in trials.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments for sleep-disordered breathing because they focus on innovative uses of occlusal stabilization splints (OSS). Unlike traditional therapies like CPAP machines or oral appliances that primarily aim to keep airways open, the mandibular and maxillary OSS, along with the modified Farrar splint, offer a targeted approach by potentially repositioning the jaw to improve airflow naturally. This method could be more comfortable for patients, as it doesn't involve wearing bulky equipment and may provide a more personalized fit. By exploring different splint designs, researchers hope to uncover effective alternatives that enhance patient comfort and compliance, leading to better outcomes.

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

This trial will compare the effectiveness of different splints for managing obstructive sleep apnea (OSA). Research has shown that mandibular occlusal stabilization splints (OSS), one of the treatments in this trial, can help manage OSA, particularly in severe cases. Studies have found that these splints significantly improve symptoms and reduce the apnea-hypopnea index (AHI), which measures how often breathing is disrupted during sleep. Mandibular advancement devices also prove effective over the long term, reducing sleepiness and improving oxygen levels during sleep.

Another treatment arm in this trial involves maxillary OSS. While direct evidence about their effect on sleep issues is limited, most studies focus on their effectiveness with dental implants rather than sleep disorders.

The trial also includes a treatment arm with the modified Farrar splint. This splint has improved jaw movement and reduced joint noise, but its effect on breathing problems during sleep remains undocumented. Its main benefits seem related to aligning the jaw rather than improving breathing.678910

Who Is on the Research Team?

AG

Aaron Glick, DDS

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

Inclusion Criteria

You are currently using a dental device called an occlusal splint.
You have been diagnosed with teeth grinding during sleep.

Exclusion Criteria

Secondary obstructive sleep apnea diagnosis
Patient refuses to sign informed consent document
You have a genetic condition that may cause breathing difficulties during sleep.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a mandibular occlusal stabilization splint (OSS), modified farrar splint, or maxillary OSS to assess effects on sleep bruxism and respiratory indices

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including imaging to assess airway volume

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mandibular OSS
  • Maxillary OSS
  • Modified farrar splint
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Modified farrar splintExperimental Treatment1 Intervention
Group II: Maxillary OSSExperimental Treatment1 Intervention
Group III: Mandibular OSSExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/39833552/
Evaluating the effectiveness of mandibular advancement ...MADs are effective in managing very severe OSA, providing significant reductions in AHI and symptom improvements.
Systematic review & Meta-analysis Efficacy and adherence ...OAs have been effective for approximately 50%-70% of OSA patients with greater adherence, improving both OSA symptoms and a variety of physiological and ...
Long-term efficacy of mandibular advancement devices in the ...The results of the study suggested that the long-term effect of MAD in the treatment of OSA is reliable. Subjective efficacy, represented by ESS ...
Comparative efficacy of mandibular advancement devices in ...Other outcomes of interest extracted from the studies were the Epworth sleepiness scale score. (ESS), minimum oxygen saturation (minSaO2), and sleep efficiency ...
Mandibular advancement devices, irrespective of amount of ...Effectiveness of MADs in the treatment of OSA does not depend on the final titrated advancement achieved. However, younger patients benefit more from MADs.
Quality & SafetyAllergic reactions are highly unlikely because Geistlich Bio-Oss® does not contain organic components. Geistlich Bio-Oss® Collagen contains collagen; allergic ...
7.psdcdn.blob.core.windows.netpsdcdn.blob.core.windows.net/coshh/NIG019.pdf
Technical Data Sheet - Product(s): Geistlich Bio-Oss ... - NETGeistlich Bio-Oss® Collagen is to be used by licensed dentists/physicians trained in surgical management of hard tissue defects in the oral- maxillofacial ...
K122894 - accessdata.fda.govBased on the available data it can be concluded that Geistlich Bio-Oss® manufactured from bovine bone sourced in and bovine bone sourced in.
9.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36769607/
Safety and Efficacy of Midface Augmentation Using Bio ...To evaluate the safety and efficacy of midface augmentation using Bio-Oss bone powder in treating midface retrusion and resulting nasolabial folds.
Geistlich USA: Downloads Dental ProfessionalsAvailable downloads include product information, brochures for portfolios, technical guidelines, videos, and instructions for use documents.
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