Bite Force Measurements

Recruiting

• Conditions: Irreversible Pulpitis; Apical Periodontitis; Pulpal Necrosis

• Registration Number: NCT06843525
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-20
• Study First Posted: 2025-02-25
• Status Verified: 2025-05
• Study Start: 2025-05-16
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-04-01
• Study Completion: 2026-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mechanical Allodynia	10 minutes post-local anesthesia	Ipsilateral full arch and tooth specific bite-force
Central Sensitization	10 minutes post-local anesthesia	Contralateral tooth specific bite-force

Secondary Outcome Measures

Name	Time	Method
Assessment of tooth vitality	10 minutes post-local anesthesia	Cold Test and Electric Pulp Test
Numerical Pain Rating Score	10 minutes post-local anesthesia	Patient-reported pain on 0-10 scale

Trial Locations

Locations (1)

Rutgers School of Dental Medicine; 🇺🇸 Newark, New Jersey, United States