Temporomandibular Joint DisordersNCT05827263
Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces
A study testing T-Scan occlusal recording No. I, Usage of the hydrostatic appliance and T-Scan occlusal recording No. II in people with Temporomandibular Joint Disorders, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders
- What is being tested?
- T-Scan occlusal recording No. I, Usage of the hydrostatic appliance and T-Scan occlusal recording No. II
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Dec 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
Show all 10Show fewer
- no tenderness on percussion of any teeth;
- no history of previous endodontic and orthodontic treatment,
- extensive maxillofacial surgery;
- no systematic neurological disorders.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
- Conditions
- Temporomandibular Joint Disorders
- Being tested
- T-Scan occlusal recording No. I, Usage of the hydrostatic appliance, T-Scan occlusal recording No. II
- Keywords
- Occlusal splints, Dental occlusion, Balanced Dental Occlusion, Temporomandibular Joint Disorders, Bite Force, Centric Dental Occlusion, Dental Equipment
- Medical subject headings
- Temporomandibular Joint Disorders, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-Scan occlusal recording No. IDiagnostic 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 applianceDevice
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. IIDiagnostic test
The occlusal registration was repeated three times using the T-Scan device in order to confirm the findings.
| Study group | Role | What they receive |
|---|---|---|
| Control group - non-temporomandibular disorders group. | Active comparator | Patients diagnosed with no temporomandibular disorders. Receives: Diagnostic Test: T-Scan occlusal recording No. I; Device: Usage of the hydrostatic appliance; Diagnostic Test: T-Scan occlusal recording No. II |
| Test group - temporomandibular disorders group | Experimental | Patients diagnosed with mild, moderate, or severe temporomandibular disorders. Receives: Diagnostic Test: T-Scan occlusal recording No. I; Device: Usage of the hydrostatic appliance; Diagnostic Test: T-Scan occlusal recording No. II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of percentage force distribution per sector.
Measured: Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.
Change of percentage force distribution for single dental elements.
Measured: Change of percentage force distribution for single dental elements at 30-minute of hydrostatic appliance usage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start1 Dec 2021
- Primary completion1 Jan 2022
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gediminas Žekonis, Lithuanian University of Health Sciences
- Investigators
- Mante Kireilyte, Study chair, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827263
- Sponsor's protocol ID
- BE-2-48
- Status last verified
- Apr 2023
- First submitted
- 21 Mar 2023
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporary Hydrostatic Splint Therapy and Its Effects on Occlusal Forces
- ClinicalTrials.gov ID
- NCT05827263
- Acronym / sponsor ID
- BE-2-48
- Conditions
- Temporomandibular Joint Disorders
- Keywords
- Occlusal splints, Dental occlusion, Balanced Dental Occlusion, Temporomandibular Joint Disorders, Bite Force, Centric Dental Occlusion, Dental Equipment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group - non-temporomandibular disorders group. | Active comparator | Diagnostic Test: T-Scan occlusal recording No. I, Device: Usage of the hydrostatic appliance, Diagnostic Test: T-Scan occlusal recording No. IIPatients diagnosed with no temporomandibular disorders. |
| Test group - temporomandibular disorders group | Experimental | Diagnostic Test: T-Scan occlusal recording No. I, Device: Usage of the hydrostatic appliance, Diagnostic Test: T-Scan occlusal recording No. IIPatients diagnosed with mild, moderate, or severe temporomandibular disorders. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-Scan occlusal recording No. IOcclusal information was obtained using the T-Scan device before the main intervention. This process was repeated three times to confirm the findings. | Diagnostic test | Control group - non-temporomandibular disorders group., Test group - temporomandibular disorders group |
| Usage of the hydrostatic applianceThe 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. | Device | Control group - non-temporomandibular disorders group., Test group - temporomandibular disorders group |
| T-Scan occlusal recording No. IIThe occlusal registration was repeated three times using the T-Scan device in order to confirm the findings. | Diagnostic test | Control group - non-temporomandibular disorders group., Test group - temporomandibular disorders group |
Primary outcome
Change of percentage force distribution per sector.
Time frame: Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: 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.
Related trials for Temporomandibular Joint Disorders
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
Recruiting
Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome
Myofacial Pain, Myofacial Pain Syndrome
Recruiting
Clinical and Electromyographic Assessment of Occlusal Splint Therapy
Temporomandibular Joint Disorders
Recruiting
An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders
Temporomandibular Disorder, Orofacial Pain
Enrolling by invitationObservational study
Long-term Safety and Performance of Materialise's Patient-specific TMJ System.
Temporomandibular Joint Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mante Kireilyte study chair
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T-Scan occlusal recording No. I, Usage of the hydrostatic appliance and T-Scan occlusal recording No. II in people with Temporomandibular Joint Disorders, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of percentage force distribution per sector. (time frame: Change of percentage force distribution per sector at 30-minute of hydrostatic appliance usage.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.