Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

NCT05827263 | Completed FDA Device

• 1 other identifier: BE-2-48
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Joint Disorders

Keywords

Occlusal splints; Dental occlusion; Balanced Dental Occlusion; Temporomandibular Joint Disorders; Bite Force; Centric Dental Occlusion; Dental Equipment

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Control group - non-temporomandibular disorders group.

ACTIVE COMPARATOR

Patients diagnosed with no temporomandibular disorders.

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

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

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

Interventions

T-Scan occlusal recording No. I DIAGNOSTIC_TEST

Occlusal information was obtained using the T-Scan device before the main intervention. This process was repeated three times to confirm the findings.

Control group - non-temporomandibular disorders group.; Test group - temporomandibular disorders group

Usage of the hydrostatic appliance DEVICE

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.

Control group - non-temporomandibular disorders group.; Test group - temporomandibular disorders group

T-Scan occlusal recording No. II DIAGNOSTIC_TEST

The occlusal registration was repeated three times using the T-Scan device in order to confirm the findings.

Control group - non-temporomandibular disorders group.; Test group - temporomandibular disorders group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

MK Dental Studio

Marijampolė, 68241, Lithuania

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bites and Stings

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Mante Kireilyte

  Lithuanian University of Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2023
• First Posted: April 25, 2023
• Study Start: December 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

LI (1)