NCT05827263

Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Lithuanian University of Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this non-randomized controlled trial is to analyze and compare occlusal force distribution patterns using T-Scan III before and after hydrostatic splint therapy on both healthy subjects and subjects with temporomandibular disorders. The main questions it aims to answer are: * Do occlusal forces for individual teeth differ before and after hydrostatic splint therapy? * Does the percentage distribution of forces across different sectors differ before and after hydrostatic splint therapy? Participants will: * Perform occlusal analysis using the T-Scan III device; * Use a hydrostatic splint for 30 minutes; * Perform a second occlusal analysis after using the hydrostatic splint. Researchers will compare healthy subjects and subjects with temporomandibular disorders to see if hydrostatic splint therapy makes a difference in the distribution patterns of occlusal forces.

Conditions

• Temporomandibular Joint Disorders

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	T-Scan occlusal recording No. I	Occlusal information was obtained using the T-Scan device before the main intervention. This process was repeated three times to confirm the findings.
DEVICE	Usage of the hydrostatic appliance	The hydrostatic appliance was removed from its packaging and placed symmetrically between the upper lip and the oral vestibule of the maxilla for the most comfortable position. After 30 minutes, the hydrostatic appliance was removed, and patients were asked to keep their mouths open until the T-Scan was positioned correctly.
DIAGNOSTIC_TEST	T-Scan occlusal recording No. II	The occlusal registration was repeated three times using the T-Scan device in order to confirm the findings.

Timeline

• Start date: 2021-12-01
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2023-04-25
• Last updated: 2023-04-25

Locations

1 site across 1 country: Lithuania

Regulatory

• FDA-regulated device study