Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

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.

Study Overview

• Status: Completed
• Conditions: Temporomandibular Joint Disorders
• Intervention / Treatment: Diagnostic test: T-Scan occlusal recording No. I; Device: Usage of the hydrostatic appliance; Diagnostic test: T-Scan occlusal recording No. II

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lithuania
  • Marijampole, Lithuania, 68241
    • MK Dental Studio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group - non-temporomandibular disorders group.; Patients diagnosed with no temporomandibular disorders.	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.
Experimental: Test group - temporomandibular disorders group; Patients diagnosed with mild, moderate, or severe temporomandibular disorders.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Lithuanian University of Health Sciences
• Investigators: Study Chair: Mante Kireilyte, Lithuanian University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: March 21, 2023
• First Submitted That Met QC Criteria: April 11, 2023
• First Posted (Actual): April 25, 2023

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Temporomandibular Joint Disorders; Dental occlusion; Occlusal splints; Balanced Dental Occlusion; Bite Force; Centric Dental Occlusion; Dental Equipment
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: BE-2-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Yes, there is a plan to make individual participant data and related data dictionaries available to other researchers. In addition to sharing the individual participant data, we also plan to publish a scientific article in the Journal of Dental Research to disseminate our findings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes