Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

NCT ID: NCT05827263

Last Updated: 2023-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-01-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control group - non-temporomandibular disorders group.

Patients diagnosed with no temporomandibular disorders.

Group Type: ACTIVE_COMPARATOR

T-Scan occlusal recording No. I

Intervention Type: 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.

Usage of the hydrostatic appliance

Intervention Type: 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.

T-Scan occlusal recording No. II

Intervention Type: DIAGNOSTIC_TEST

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

Test group - temporomandibular disorders group

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

Group Type: EXPERIMENTAL

T-Scan occlusal recording No. I

Intervention Type: 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.

Usage of the hydrostatic appliance

Intervention Type: 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.

T-Scan occlusal recording No. II

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DEVICE

T-Scan occlusal recording No. II

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lithuanian University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Gediminas Žekonis

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mante Kireilyte

Role: STUDY_CHAIR

Lithuanian University of Health Sciences

Locations

MK Dental Studio

Marijampolė, , Lithuania

Countries

Lithuania

Other Identifiers

BE-2-48

Identifier Type: -

Identifier Source: org_study_id