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Completed

NCT Number: NCT05827263

Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces

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.

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Key information

Conditions

Temporomandibular Joint Disorders Bites and Stings Chemically-Induced Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Poisoning Stomatognathic Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MK Dental Studio

Marijampolė, 68241, Lithuania

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

T-Scan occlusal recording No. I

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

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

Diagnostic Test

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

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.

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 25, 2023
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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