Recruiting

Observational Study

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT06843525

Conditions

Irreversible Pulpitis

Apical Periodontitis

Pulpal Necrosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Irreversible Pulpitis

Apical Periodontitis

Pulpal Necrosis

Study ID

NCT06843525

Start date

May 16, 2025

Status verified date

Jul, 2025

Completion date

Nov 1, 2026

Anticipated

Primary completion date

Apr 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

112 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy Controls

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

Affected Pulp/Healthy Apex

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

Diseased Pulp/ Healthy Apex

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

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 ]
  • Mechanical Allodynia [ Time Frame: 10 minutes post-local anesthesia ]
  • Central Sensitization [ Time Frame: Baseline ]
  • Central Sensitization [ Time Frame: 10 minutes post-local anesthesia ]

Central Contacts and Locations

Central contacts

Gayathri D Subramanian, PhD, DMD

973 972 3418subramga@sdm.rutgers.edu

Locations

Rutgers School of Dental Medicine

Recruiting

Newark, New Jersey, United States, 07103

Contacts

Vanessa Chrepa, DDS,MS, PhD

973-972-7331vanessa.chrepa@rutgers.edu

Gayathri Subramanian, DMD, PhD

973-972-2444subramga@sdm.rutgers.edu

Principal Investigator:

Vanessa Chrepa, DDS, MS, PhD

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Jul 24, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2025-07-24.