RECRUITING

Bite Force Measurements

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Exploring a Neuropathic Basis for Acute Pulpal Pain- a Clinical Pilot

Quick Facts

Study Start:2025-05-16
Study Completion:2026-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06843525

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Individuals who present for
  2. * 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
  3. * a lower molar root canal treatment, and
  4. * are 18 years or older
  5. * capable of providing informed consent, are eligible to participate in the study, as long as they satisfy the criteria below.
  6. * 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
  7. * are English-speaking
  1. * Any patient, even if satisfying the criteria above, may not take part if any of the below is true:
  2. * 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.
  3. * Take prescription pain medications for long-standing health conditions
  4. * Addiction/ substance dependence
  5. * Swelling that extends beyond the tooth in question
  6. * Are already taking an antibiotic to treat an infection/swelling
  7. * Missing complementary molar on the same or opposite side of the mouth
  8. * Missing more than 2 teeth in a quadrant (other than 3rd molars)
  9. * 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
  10. * The patient has taken a pain medication within the last 6 hours

Contacts and Locations

Study Contact

Gayathri D Subramanian, PhD, DMD
CONTACT
973 972 3418
subramga@sdm.rutgers.edu

Principal Investigator

Varvara Vanessa Chrepa, DDS, MS, PhD
PRINCIPAL_INVESTIGATOR
Rutgers School of Dental Medicine
Gayathri Subramanian, PhD, DMD
PRINCIPAL_INVESTIGATOR
Rutgers School of Dental Medicine

Study Locations (Sites)

Rutgers School of Dental Medicine
Newark, New Jersey, 07103
United States

Collaborators and Investigators

Sponsor: Rutgers, The State University of New Jersey

  • Varvara Vanessa Chrepa, DDS, MS, PhD, PRINCIPAL_INVESTIGATOR, Rutgers School of Dental Medicine
  • Gayathri Subramanian, PhD, DMD, PRINCIPAL_INVESTIGATOR, Rutgers School of Dental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-16
Study Completion Date2026-11-01

Study Record Updates

Study Start Date2025-05-16
Study Completion Date2026-11-01

Terms related to this study

Additional Relevant MeSH Terms

  • Irreversible Pulpitis
  • Apical Periodontitis
  • Pulpal Necrosis