Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Lithuanian University of Health Sciences

Status: Completed

Conditions: Temporomandibular Joint Disorders

Treatments: Diagnostic Test: T-Scan occlusal recording No. II; Diagnostic Test: T-Scan occlusal recording No. I; Device: Usage of the hydrostatic appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT05827263

BE-2-48

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Control group - non-temporomandibular disorders group.

Active Comparator group

Description:

Patients diagnosed with no temporomandibular disorders.

Treatment:

Diagnostic Test: T-Scan occlusal recording No. I

Device: Usage of the hydrostatic appliance

Diagnostic Test: T-Scan occlusal recording No. II

Test group - temporomandibular disorders group

Experimental group

Description:

Patients diagnosed with mild, moderate, or severe temporomandibular disorders.

Treatment:

Diagnostic Test: T-Scan occlusal recording No. I

Device: Usage of the hydrostatic appliance

Diagnostic Test: T-Scan occlusal recording No. II