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Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

NCT05827263 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-04-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Lithuanian University of Health Sciences

    lead OTHER

Principal Investigators

  • Mante Kireilyte · Lithuanian University of Health Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2022-01-01
Completion
2022-01-01
FDA Device
Yes

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05827263 on ClinicalTrials.gov