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NCT Number: NCT07163494

Occlusal Sensitivity to Articulating Foils in Patients With Temporomandibular Disorders and Healthy Controls

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

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.

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Exclusion criteria

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.

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.

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Treatment and study plan

Primary outcomes

  1. Occlusal Sensitivity Threshold

    Time frame: Up to 1 hour per participant.

  2. Case-Control Comparison

    Time frame: Up to 1 hour per participant.

Secondary outcomes

  1. Clinical TMD Manifestation and Occlusal Sensitivity

    Time frame: Up to 1 hour per participant.

Sponsors and collaborators

Lead sponsor

University of Zagreb

Other

Collaborators

  • Croatian Science Foundation

Registry information

Official study title

Assessment of Occlusal Sensitivity to Articulating Foils in Patients With Temporomandibular Disorders Compared to Healthy Controls: A Case-Control Study

Acronym: SENFOIL

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

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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