Bite Force Measurements
Part of paid clinical trials in Newark, New Jersey.
- Sponsor
- Rutgers, The State University of New Jersey
- Study ID
- NCT06843525
- Status
- Recruiting
Conditions
- Apical Periodontitis
- Irreversible Pulpitis
- Pulpal Necrosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 89 Years
- Healthy Volunteers
- Not accepted
Study Details
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 Dates
- Start date
- May 16, 2025
- Status verified
- Jul 2025
- Primary completion
- Apr 1, 2026
- Completion
- Nov 1, 2026
Study Design
- Enrollment
- 112 participants (estimated)
Arms
- Arm: Healthy ControlsPatients who require a restoration on a vital but carious lower 1st or second molar tooth
- Arm: Affected Pulp/Healthy ApexPatients who have a carious 1st or second lower molar tooth with pulpal involvement in a vital tooth
- Arm: Diseased Pulp/ Healthy ApexPatients who experience irreversible pulpitis or pulpal necrosis in a lower 1st or second molar tooth
- Arm: Diseased Pulp/Diseased ApexPatients 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
Primary Outcome Measure
Mechanical Allodynia [ Time Frame: Baseline ]
Central Contacts
- Gayathri D Subramanian, PhD, DMD973 972 3418
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rutgers School of Dental Medicine | Newark | New Jersey | 07103 | Vanessa Chrepa, DDS, MS, PhD (PRINCIPAL_INVESTIGATOR) Gayathri Subramanian, DMD, PhD (PRINCIPAL_INVESTIGATOR) |
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