Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Not Applicable

Completed

• Conditions: Temporomandibular Joint Disorders

• 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

Primary Outcome Measures

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

Trial Locations

Locations (1)

MK Dental Studio; 🇱🇹 Marijampole, Lithuania