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Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05827263
Enrollment
51
Registered
2023-04-25
Start date
2021-12-01
Completion date
2022-01-01
Last updated
2023-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Temporomandibular Joint Disorders

Keywords

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

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.

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.

Sponsors

Lithuanian University of Health Sciences
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime 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.

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026