Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Temporomandibular Joint Disorders Clinical Trial

Official title:

Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05827263
• Other study ID #: BE-2-48
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2023
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Diseases
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

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.

Locations

Country	Name	City	State
Lithuania	MK Dental Studio	Marijampole

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of percentage force distribution per sector.		Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.
Primary	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.