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CompletedNCT05827263Updated Apr 25, 2023

Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

An interventional study of T-Scan occlusal recording No. I and Usage of the hydrostatic appliance in Temporomandibular Joint Disorders, sponsored by Lithuanian University of Health Sciences. Completed at 1 site in Lithuania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-25.

Sponsored by Lithuanian University of Health Sciences · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Jan 2022, 4 years 9 months ago, and no results have been posted to the registry.
  • Registered 1 year 3 months after the study started (first participant enrolled Dec 2021, registered Mar 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Temporomandibular Joint Disorders

Keywords

  • Occlusal splints
  • Dental occlusion
  • Balanced Dental Occlusion
  • Temporomandibular Joint Disorders
  • Bite Force
  • Centric Dental Occlusion
  • Dental Equipment
03

In context

Joint Diseases

712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.

This study's enrollment of 51 is below the median of 60 across 470 interventional studies indexed under Joint Diseases.

Browse Joint Diseases studies →

Lead sponsor

Lithuanian University of Health Sciences is the lead sponsor of 102 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
51 participants (actual)

Study arms

  • Active comparator
    Control group - non-temporomandibular disorders group.

    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

  • Experimental
    Test group - temporomandibular disorders group

    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

  • Diagnostic testT-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.

  • DeviceUsage 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 testT-Scan occlusal recording No. II

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

06

What researchers measure

Primary outcomes

  1. Change of percentage force distribution per sector.

    Time frame: Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.

  2. 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.

07

Study locations

1 site
  • MK Dental Studio
    Marijampole, 68241, Lithuania
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05827263
Lead sponsor
Lithuanian University of Health Sciences
Responsible party
Gediminas Žekonis (Professor, Lithuanian University of Health Sciences) — Principal investigator
First posted
Apr 25, 2023
Start date
Dec 1, 2021
Primary completion
Jan 1, 2022
Completion
Jan 1, 2022
Last update
Apr 25, 2023

Study contacts

Mante Kireilyte
study chair · Lithuanian University of Health Sciences

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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