Occlusal Stabilization Splints and Sleep Disordered Breathing

Overseen By Aaron Glick, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Secondary sleep apnea, Genetic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

Trial Summary

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 data supports the effectiveness of the treatment involving Mandibular OSS, Maxillary OSS, and Modified Farrar splint?

The research suggests that using computer-designed and manufactured splints can accurately position the maxilla (upper jaw) during surgery, which is important for treatments involving jaw alignment. Additionally, a modified splint can help correct deep overbite by allowing quicker orthodontic adjustments and improving facial structure. ^{1 2 3 4 5}

Is the treatment known as Mandibular OSS, Maxillary OSS, or Modified Farrar Splint safe for humans?

The research articles reviewed do not provide specific safety data for the treatment known as Mandibular OSS, Maxillary OSS, or Modified Farrar Splint. They focus on the manufacturing processes, fitting, and stress distribution of splints, but do not address safety in humans. ^{3 6 7 8 9}

How does the treatment involving Mandibular OSS, Maxillary OSS, and Modified Farrar splint differ from other treatments for this condition?

This treatment is unique because it uses a modified splint that allows for rapid extrusion of posterior teeth, reducing the time needed for preoperative orthodontic treatment and enabling continued orthodontic adjustments during the recovery period. This approach can improve facial height and chin position while facilitating food intake during immobilization. ^{1 2 3 4 10}

What is the purpose of this trial?

This trial is testing two types of mouthguards to see if they can help people who grind their teeth at night and have breathing problems. The mouthguards aim to reduce teeth grinding and improve breathing by changing the jaw's position and increasing airway space.

Research Team

Aaron Glick, DDS

Principal Investigator

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Timeline

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

Treatment Details

Interventions

• Mandibular OSS
• Maxillary OSS
• Modified farrar splint

Participant Groups

Group I: Modified farrar splint Experimental Treatment 1 Intervention

Group II: Maxillary OSS Experimental Treatment 1 Intervention

Group III: Mandibular OSS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Accuracy of maxillary positioning using computer-designed and manufactured occlusal splints or patient-specific implants in orthognathic surgery. [2023]

2. Scotland pubmed.ncbi.nlm.nih.gov

Correction of deep overbite. A modified splint permitting rapid extrusion of posterior teeth. [2019]

3. England pubmed.ncbi.nlm.nih.gov

CAD/CAM splint and surgical navigation allows accurate maxillary segment positioning in Le Fort I osteotomy. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A novel design of a computer-generated splint for vertical repositioning of the maxilla after Le Fort I osteotomy. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

The Accuracy of Maxillary Position Using a Computer-Aided Design/Computer-Aided Manufacturing Intermediate Splint Derived Via Surgical Simulation in Bimaxillary Orthognathic Surgery. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Evaluation of wear behaviour of various occlusal splint materials and manufacturing processes. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Finite element analysis of stress distribution with splinted and nonsplinted maxillary anterior fixed prostheses supported by zirconia or titanium implants. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Digitally programmed (CAD) offset values for prototyped occlusal splints (CAM): assessment of appliance-fitting using surface-based superimposition and deviation analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Patients' perceptions on temporomandibular disorder treatment with hydrostatic oral splints - a pilot study. [2022]

10. Denmark pubmed.ncbi.nlm.nih.gov

Palatal surgical splint for transverse stability of Le Fort I osteotomies: a technical note. [2019]