Temporomandibular Disorder (TMD)SENFOILNCT07163494
Occlusal Sensitivity to Articulating Foils in Patients With Temporomandibular Disorders and Healthy Controls
An observational study of Temporomandibular Disorder (TMD) and Chronic Pain, run by University of Zagreb.
Trial summary
Occlusal sensitivity refers to the ability to detect fine objects placed between opposing teeth during biting or in maximum intercuspation. Two main approaches are commonly used to assess occlusal sensitivity and the periodontal sensory threshold: one measures the minimal detectable force using monofilaments, while… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder (TMD), Chronic Pain
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Nov 2025
- Phase
- Observational
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All participants will be Caucasian, of Middle or Southern European descent. The study will include employees of the Department of Dental Medicine at the Clinical Hospital Centre Zagreb, as well as employees and students of the University of Zagreb School of Dental Medicine, along with healthy volunteers.
Who may be able to join
- Reported pain in the temporomandibular joint (TMJ) and/or masticatory muscles persists for more than 3 months.
- Spontaneous pain >30 mm on the Visual Analogue Scale (VAS) at the time of the first examination.
- -
Who cannot join
- Loss of posterior teeth leads to loss of occlusal support zones.
- Posterior removable dentures.
- Poor oral hygiene or periodontal disease.
- Orofacial pathology unrelated to TMD diagnosis.
- Acute pain (duration <3 months).
- History of head and neck trauma.
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- Headache not related to TMD (according to the International Classification of Headache Disorders, ICHD-II).
- Pain caused by fibromyalgia.
- Systemic diseases or diagnosed psychiatric disorders.
- History of pain medication abuse or current substance abuse.
- -
About this study
Official title: Assessment of Occlusal Sensitivity to Articulating Foils in Patients With Temporomandibular Disorders Compared to Healthy Controls: A Case-Control Study
Occlusal sensitivity refers to the ability to detect fine objects placed between opposing teeth during biting or in maximum intercuspation. Two main approaches are commonly used to assess occlusal sensitivity and the periodontal sensory threshold: one measures the minimal detectable force using monofilaments, while the other evaluates the sensitivity threshold to interocclusal thickness with articulating foils. In healthy individuals, occlusal sensitivity ranges from 2 µm to 77 µm (average 24 µm) and tends to decrease with age. Periodontal mechanoreceptors are primarily responsible for this function, although studies indicate that other mechanoreceptors may contribute, especially in individuals with implants or prostheses. Evidence suggests that patients with painful temporomandibular disorders (TMD) may have reduced occlusal sensitivity and show less adaptability to occlusal interferences than healthy subjects. This observational case-control study assesses differences in occlusal sensitivity between patients with pain-related TMD and healthy controls. The study will also explore the relationship between sensory sensitivity, psychosomatic characteristics, and the clinical manifestations of TMD. The TMD group will include patients from the Department of Removable Prosthodontics and the Department of Oral Medicine at the University of Zagreb School of Dental Medicine, diagnosed with pain-related TMD (including myalgia, referred myofascial pain, and/or arthralgia) according to the DC/TMD criteria. The control group will consist of healthy volunteers matched for age and sex, with no neurological alterations in sensory function. The study has been approved by the Ethics Committee of the University of Zagreb School of Dental Medicine and will be conducted in accordance with the Declaration of Helsinki. All participants will receive detailed information about the study and provide written informed consent before participation. The experimental procedure will test occlusal sensitivity by assessing the ability of participants to detect different thicknesses of articulating foils, applied in randomised order between upper and lower molars, including a sham test. Participants will report whether they detect the foil, and their responses will be recorded for subsequent statistical analysis.
- Conditions
- Temporomandibular Disorder (TMD), Chronic Pain
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| case group | Not described | |
| control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusal Sensitivity Threshold
Measured: Up to 1 hour per participant.
Case-Control Comparison
Measured: Up to 1 hour per participant.
Secondary outcomes (1)
Clinical TMD Manifestation and Occlusal Sensitivity
Measured: Up to 1 hour per participant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Disorder (TMD)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Collaborators
- Croatian Science Foundation
- Responsible party
- Principal investigator, Marko Zlendić, DMD, PhD, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07163494
- Sponsor's protocol ID
- 05-PA-30-22-11/2023
- Other IDs
- SFZG-07-2025_LIPOR
- Acronym
- SENFOIL
- Status last verified
- Sep 2025
- First submitted
- 1 Sep 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No