Bite Force Measurements

Recruiting now

Conditions studied: Irreversible Pulpitis, Apical Periodontitis, Pulpal Necrosis

In brief

ABSTRACT: Acute dental pain from untreated decay often drives patients to emergency rooms (ERs), where the lack of definitive dental treatment results in nearly 75% of these patients receiving analgesics, predominantly opioids. Addressing the need for non-opioid pain alternatives is crucial. Emerging evidence suggests that dental pain from pulpal and periodontal conditions (affecting the tooth's nerve and surrounding tissues) involves neuropathic mechanisms, such as mechanical allodynia (MA) and central sensitization (CS). These mechanisms can amplify pain perception, causing typically non-painful actions, like chewing, to become painful and resulting in hypersensitivity extending beyond the affected tooth. Reliably identifying these mechanisms with quantitative measures can support improved pain assessment and targeted non-opioid treatment. This minimally invasive prospective cohort study will use the FDA-approved Innobyte® device, a precise bite-force measurement tool, to evaluate periodontal health and to quantify mechanical pain thresholds in patients requiring endodontic treatment (root canal therapy).

Key facts

Study ID

NCT06843525

Run by

Rutgers, The State University of New Jersey

People needed

112

Starts

2025-05-16

Expected to finish

2026-11-01

Last updated by the study team

2025-07-24

Who can join

Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Individuals who present for
• a lower 1st or 2nd molar filling in an otherwise healthy tooth, i.e., does not have large decay that has already infected the nerve of the tooth, or there is increased mobility due to gum disease or a root canal treatment on a lower molar tooth and there is no history of injury to the tooth, or
• a lower molar root canal treatment, and
• are 18 years or older
• capable of providing informed consent, are eligible to participate in the study, as long as they satisfy the criteria below.
• The opposing tooth is present, symptom-free and has adequate tooth structure that allows it to make contact with the tooth it bites against, and
• are English-speaking

You may not qualify if…

• Any patient, even if satisfying the criteria above, may not take part if any of the below is true:
• Compromised ability to guard their self-interest, for e.g., prisoners, children, pregnant women, patients with intellectual/cognitive disability are not enrolled in the study.
• Take prescription pain medications for long-standing health conditions
• Addiction/ substance dependence
• Swelling that extends beyond the tooth in question
• Are already taking an antibiotic to treat an infection/swelling
• Missing complementary molar on the same or opposite side of the mouth
• Missing more than 2 teeth in a quadrant (other than 3rd molars)
• Any other molar in the pair either on the side of the tooth of interest or the molar pair on the other side is painful to biting pressure or upon 'tapping' the tooth with the handle of the mouth mirror
• The patient has taken a pain medication within the last 6 hours

Where it is running

• Rutgers School of Dental Medicine — Newark, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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