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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.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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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
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.
Show all 11Show fewer
  • 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.

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 groups in NCT07163494
Study groupRoleWhat they receive
case groupNot described
control groupNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occlusal Sensitivity Threshold

    Measured: Up to 1 hour per participant.

  2. Case-Control Comparison

    Measured: Up to 1 hour per participant.

Secondary outcomes (1)
  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.

  1. First posted9 Sep 2025
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Nov 2025 (estimated)
  4. Study completion1 Nov 2025 (estimated)

Resources

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)
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

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