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Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Primary Purpose

Temporomandibular Joint Disorders

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
T-Scan occlusal recording No. I
Usage of the hydrostatic appliance
T-Scan occlusal recording No. II
Sponsored by
Lithuanian University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Temporomandibular Joint Disorders focused on measuring Occlusal splints, Dental occlusion, Balanced Dental Occlusion, Temporomandibular Joint Disorders, Bite Force, Centric Dental Occlusion, Dental Equipment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • MK Dental Studio

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group - non-temporomandibular disorders group.

Test group - temporomandibular disorders group

Arm Description

Patients diagnosed with no temporomandibular disorders.

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

Outcomes

Primary Outcome Measures

Change of percentage force distribution per sector.
Change of percentage force distribution for single dental elements.

Secondary Outcome Measures

Full Information

First Posted
March 21, 2023
Last Updated
April 11, 2023
Sponsor
Lithuanian University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05827263
Brief Title
Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces
Official Title
Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lithuanian University of Health Sciences

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Occlusal splints, Dental occlusion, Balanced Dental Occlusion, Temporomandibular Joint Disorders, Bite Force, Centric Dental Occlusion, Dental Equipment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group - non-temporomandibular disorders group.
Arm Type
Active Comparator
Arm Description
Patients diagnosed with no temporomandibular disorders.
Arm Title
Test group - temporomandibular disorders group
Arm Type
Experimental
Arm Description
Patients diagnosed with mild, moderate, or severe temporomandibular disorders.
Intervention Type
Diagnostic Test
Intervention Name(s)
T-Scan occlusal recording No. I
Intervention Description
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
Device
Intervention Name(s)
Usage of the hydrostatic appliance
Intervention Description
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
Diagnostic Test
Intervention Name(s)
T-Scan occlusal recording No. II
Intervention Description
The occlusal registration was repeated three times using the T-Scan device in order to confirm the findings.
Primary Outcome Measure Information:
Title
Change of percentage force distribution per sector.
Time Frame
Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.
Title
Change of percentage force distribution for single dental elements.
Time Frame
Change of percentage force distribution for single dental elements at 30-minute of hydrostatic appliance usage.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mante Kireilyte
Organizational Affiliation
Lithuanian University of Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
MK Dental Studio
City
Marijampole
ZIP/Postal Code
68241
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

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