Bite Force Measurements

NCT ID: NCT06843525

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2026-11-01

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.

Conditions

Irreversible Pulpitis; Apical Periodontitis; Pulpal Necrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Healthy Controls

Patients who require a restoration on a vital but carious lower 1st or second molar tooth

No interventions assigned to this group

Affected Pulp/Healthy Apex

Patients who have a carious 1st or second lower molar tooth with pulpal involvement in a vital tooth

No interventions assigned to this group

Diseased Pulp/ Healthy Apex

Patients who experience irreversible pulpitis or pulpal necrosis in a lower 1st or second molar tooth

No interventions assigned to this group

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

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

New Jersey Alliance for Clinical and Translational Science

UNKNOWN

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Gayathri Subramanian

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Varvara Vanessa Chrepa, DDS, MS, PhD

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Dental Medicine

Gayathri Subramanian, PhD, DMD

Role: PRINCIPAL_INVESTIGATOR

Rutgers School of Dental Medicine

Locations

Rutgers School of Dental Medicine

Newark, New Jersey, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Gayathri D Subramanian, PhD, DMD

Role: CONTACT

subramga@sdm.rutgers.edu

973 972 3418

Facility Contacts

Vanessa Chrepa, DDS,MS, PhD

Role: primary

vanessa.chrepa@rutgers.edu

973-972-7331

Gayathri Subramanian, DMD, PhD

Role: backup

subramga@sdm.rutgers.edu

973-972-2444

Other Identifiers

Pro2024002660

Identifier Type: -

Identifier Source: org_study_id