Clinical trial NCT06843525: Bite Force Measurements
Official title: Exploring a Neuropathic Basis for Acute Pulpal Pain- a Clinical Pilot
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Irreversible Pulpitis
Apical Periodontitis
Pulpal Necrosis
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: New Jersey Alliance for Clinical and Translational Science
First posted: 2025-02-25
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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).

Detailed description: This study aims to validate neuropathic mechanisms as therapeutic targets by quantifying toothache-induced mechanical allodynia. It could potentially support the use of neuropathic pain medications, like gabapentin, as adjuncts to traditional pain management. The study's findings could also reduce opioid reliance in ER settings, particularly benefiting underserved populations with limited access to dental care. This innovative approach challenges conventional views on dental pain and may provide the foundation for future research.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Mechanical Allodynia
timeFrame: Baseline
measure: Mechanical Allodynia
timeFrame: 10 minutes post-local anesthesia
measure: Central Sensitization
timeFrame: Baseline
measure: Central Sensitization
timeFrame: 10 minutes post-local anesthesia
Secondary outcomes:
measure: Assessment of tooth vitality
timeFrame: Baseline
measure: Assessment of tooth vitality
timeFrame: 10 minutes post-local anesthesia
measure: Numerical Pain Rating Score
timeFrame: Baseline
measure: Numerical Pain Rating Score
timeFrame: 10 minutes post-local anesthesia
Other outcomes:
Locations:
city: Newark
country: United States
facility: Rutgers School of Dental Medicine
state: New Jersey
Study officials:
affiliation: Rutgers School of Dental Medicine
name: Varvara Vanessa Chrepa, DDS, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers School of Dental Medicine
name: Gayathri Subramanian, PhD, DMD
role: PRINCIPAL_INVESTIGATOR
References: