| NCT ID | NCT06843525 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rutgers, The State University of New Jersey |
| Condition | Irreversible Pulpitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-05-16 |
| Primary Completion | 2026-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 112 participants in total. It began in 2025-05-16 with a primary completion date of 2026-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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
Contact & Investigator
Varvara Vanessa Chrepa, DDS, MS, PhD
PRINCIPAL INVESTIGATOR
Rutgers School of Dental Medicine
Frequently Asked Questions
Who can join the NCT06843525 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Irreversible Pulpitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06843525 currently recruiting?
Yes, NCT06843525 is actively recruiting participants. Contact the research team at subramga@sdm.rutgers.edu for enrollment information.
Where is the NCT06843525 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT06843525 clinical trial?
NCT06843525 is sponsored by Rutgers, The State University of New Jersey. The principal investigator is Varvara Vanessa Chrepa, DDS, MS, PhD at Rutgers School of Dental Medicine. The trial plans to enroll 112 participants.