Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders
• Interventions: Diagnostic Test: T-Scan occlusal recording No. I; Device: Usage of the hydrostatic appliance; Diagnostic Test: T-Scan occlusal recording No. II

• Registration Number: NCT05827263
• Lead Sponsor: Lithuanian University of Health Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-01
• Primary Completion: 2022-01-01
• Study Completion: 2022-01-01
• Study First Submitted: 2023-03-21
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-11
• Last Update Submitted: 2023-04-11
• Study First Posted: 2023-04-25
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• healthy subjects with Angle Class I and a normal line of occlusion without malpositioned or rotated teeth;
• complete permanent dentition except for the third molars;
• no fixed prosthesis;
• no dental caries;
• no restorations on the occlusal surfaces of molars and premolars extending more than one-third of the surface;
• no restorations on incisal edge;
• no tenderness on percussion of any teeth;
• no history of previous endodontic and orthodontic treatment,
• extensive maxillofacial surgery;
• no systematic neurological disorders.

Exclusion Criteria

• presence of orofacial pain that limits mouth opening;
• malocclusion (e.g., open bite, increased overjet or reverse overjet, cross bite);
• skeletal anomalies with occlusal disturbance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test group - temporomandibular disorders group	T-Scan occlusal recording No. I	Patients diagnosed with mild, moderate, or severe temporomandibular disorders.
Test group - temporomandibular disorders group	T-Scan occlusal recording No. II	Patients diagnosed with mild, moderate, or severe temporomandibular disorders.
Control group - non-temporomandibular disorders group.	Usage of the hydrostatic appliance	Patients diagnosed with no temporomandibular disorders.
Test group - temporomandibular disorders group	Usage of the hydrostatic appliance	Patients diagnosed with mild, moderate, or severe temporomandibular disorders.
Control group - non-temporomandibular disorders group.	T-Scan occlusal recording No. I	Patients diagnosed with no temporomandibular disorders.
Control group - non-temporomandibular disorders group.	T-Scan occlusal recording No. II	Patients diagnosed with no temporomandibular disorders.

Primary Outcome Measures

Name	Time	Method
Change of percentage force distribution per sector.	Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.
Change of percentage force distribution for single dental elements.	Change of percentage force distribution for single dental elements at 30-minute of hydrostatic appliance usage.

Trial Locations

Locations (1)

MK Dental Studio; 🇱🇹 Marijampole, Lithuania