About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Individuals who present to Rutgers School of Dental Medicine 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 for a lower molar root canal treatment in the 1st or second molar tooth will be enrolled in this study.
Trial design
Cohort
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Mechanical Allodynia
Ipsilateral full arch and tooth specific bite-force
Mechanical Allodynia
Ipsilateral full arch and tooth specific bite-force
Central Sensitization
Contralateral tooth specific bite-force
Central Sensitization
Contralateral tooth specific bite-force
Secondary outcomes
Assessment of tooth vitality
Cold Test and Electric Pulp Test
Assessment of tooth vitality
Cold Test and Electric Pulp Test
Numerical Pain Rating Score
Patient-reported pain on 0-10 scale
Numerical Pain Rating Score
Patient-reported pain on 0-10 scale
Sponsors and contacts
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Rutgers, The State University of New Jersey
Lead sponsor
New Jersey Alliance for Clinical and Translational Science
Collaborator