Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Study Overview
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Brief Summary
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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.

Official Title
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Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

Conditions
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Temporomandibular Joint Disorders

Intervention / Treatment
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* Diagnostic Test: T-Scan occlusal recording No. I
* Device: Usage of the hydrostatic appliance
* Diagnostic Test: T-Scan occlusal recording No. II


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group - non-temporomandibular disorders group.<br>Patients diagnosed with no temporomandibular disorders. | Diagnostic Test: T-Scan occlusal recording No. I<br>* Occlusal information was obtained using the T-Scan device before the main intervention. This process was repeated three times to confirm the findings.<br>Device: Usage of the hydrostatic appliance<br>* 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.<br>Diagnostic Test: T-Scan occlusal recording No. II<br>* The occlusal registration was repeated three times using the T-Scan device in order to confirm the findings.<br>|
| Experimental: Test group - temporomandibular disorders group<br>Patients diagnosed with mild, moderate, or severe temporomandibular disorders. | Diagnostic Test: T-Scan occlusal recording No. I<br>* Occlusal information was obtained using the T-Scan device before the main intervention. This process was repeated three times to confirm the findings.<br>Device: Usage of the hydrostatic appliance<br>* 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.<br>Diagnostic Test: T-Scan occlusal recording No. II<br>* The occlusal registration was repeated three times using the T-Scan device in order to confirm the findings.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Occlusal splints, Dental occlusion, Balanced Dental Occlusion, Temporomandibular Joint Disorders, Bite Force, Centric Dental Occlusion, Dental Equipment