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 Controls
    Patients who require a restoration on a vital but carious lower 1st or second molar tooth
  • Arm: Affected Pulp/Healthy Apex
    Patients who have a carious 1st or second lower molar tooth with pulpal involvement in a vital tooth
  • Arm: Diseased Pulp/ Healthy Apex
    Patients who experience irreversible pulpitis or pulpal necrosis in a lower 1st or second molar tooth
  • Arm: 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

Primary Outcome Measure

Mechanical Allodynia [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rutgers School of Dental MedicineNewarkNew Jersey07103
Vanessa Chrepa, DDS,MS, PhD
973-972-7331
Gayathri Subramanian, DMD, PhD
973-972-2444
Vanessa Chrepa, DDS, MS, PhD (PRINCIPAL_INVESTIGATOR)
Gayathri Subramanian, DMD, PhD (PRINCIPAL_INVESTIGATOR)

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