Exploring a Neuropathic Basis for Acute Pulpal Pain- a Clinical Pilot

Status: Recruiting
Location: See location...
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Rutgers School of Dental Medicine
RECRUITING
Newark
Contact Information
Primary
Gayathri D Subramanian, PhD, DMD
subramga@sdm.rutgers.edu
973 972 3418
Time Frame
Start Date: 2025-05-16
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 112
Treatments
Healthy Controls
Patients who require a restoration on a vital but carious lower 1st or second molar tooth
Affected Pulp/Healthy Apex
Patients who have a carious 1st or second lower molar tooth with pulpal involvement in a vital tooth
Diseased Pulp/ Healthy Apex
Patients who experience irreversible pulpitis or pulpal necrosis in a lower 1st or second molar tooth
Diseased Pulp/Diseased Apex
Patients who experience irreversible pulpitis or pulpal necrosis in a lower 1st or second molar tooth and have tenderness to palpation/percussion due to apical periodontitis or demonstrate radiographic evidence of periapical pathology
Related Therapeutic Areas
Sponsors
Leads: Rutgers, The State University of New Jersey
Collaborators: New Jersey Alliance for Clinical and Translational Science

This content was sourced from clinicaltrials.gov