NCT06843525

Bite Force Measurements

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 112 (estimated)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irreversible Pulpitis
• Apical Periodontitis
• Pulpal Necrosis

Timeline

• Start date: 2025-05-16
• Primary completion: 2026-04-01
• Completion: 2026-11-01
• First posted: 2025-02-25
• Last updated: 2025-07-24

Locations

1 site across 1 country: United States