Bite Force Measurements

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

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).

Study Overview

• Status: Recruiting
• Conditions: Apical Periodontitis; Irreversible Pulpitis; Pulpal Necrosis

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 Type: Observational
• Enrollment (Estimated): 112

Contacts and Locations

• Study Contact: Name: Gayathri D Subramanian, PhD, DMD; Phone Number: 973 972 3418; Email: subramga@sdm.rutgers.edu

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Recruiting
      • Rutgers School of Dental Medicine
      • Contact: Vanessa Chrepa, DDS,MS, PhD; Phone Number: 973-972-7331; Email: vanessa.chrepa@rutgers.edu
      • Contact: Gayathri Subramanian, DMD, PhD; Phone Number: 973-972-2444; Email: subramga@sdm.rutgers.edu
      • Principal Investigator: Vanessa Chrepa, DDS, MS, PhD
      • Principal Investigator: Gayathri Subramanian, DMD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals who present to Rutgers School of Dental Medicine 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 for a lower molar root canal treatment in the 1st or second molar tooth will be enrolled in this study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mechanical Allodynia	Ipsilateral full arch and tooth specific bite-force	Baseline
Mechanical Allodynia	Ipsilateral full arch and tooth specific bite-force	10 minutes post-local anesthesia
Central Sensitization	Contralateral tooth specific bite-force	Baseline
Central Sensitization	Contralateral tooth specific bite-force	10 minutes post-local anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of tooth vitality	Cold Test and Electric Pulp Test	Baseline
Assessment of tooth vitality	Cold Test and Electric Pulp Test	10 minutes post-local anesthesia
Numerical Pain Rating Score	Patient-reported pain on 0-10 scale	Baseline
Numerical Pain Rating Score	Patient-reported pain on 0-10 scale	10 minutes post-local anesthesia

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Collaborators: New Jersey Alliance for Clinical and Translational Science
• Investigators: Principal Investigator: Varvara Vanessa Chrepa, DDS, MS, PhD, Rutgers School of Dental Medicine; Principal Investigator: Gayathri Subramanian, PhD, DMD, Rutgers School of Dental Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: February 20, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): February 25, 2025

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 22, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Periapical Diseases; Jaw Diseases; Dental Pulp Diseases; Tooth Diseases; Periodontitis; Periapical Periodontitis; Dental Pulp Necrosis; Necrosis; Pulpitis
• Other Study ID Numbers: Pro2024002660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the key results of the study will be available after deidentification to individuals submitting a written request. The study protocol and informed consent documents, and aggregate data will be shared on ClinicalTrials.gov. The data will be made available about 9 months and ending 36 months after publication, if the investigators whose proposed use of the data has been approved by an independent review committee.
• IPD Sharing Time Frame: A year after completion of the study and data analysis
• IPD Sharing Access Criteria: Individual participant data that underlie the key results of the study will be available after deidentification to individuals submitting a written request. The study protocol and informed consent documents, and aggregate data will be shared on ClinicalTrials.gov. The data will be made available about 9 months and ending 36 months after publication, if the investigators whose proposed use of the data has been approved by an independent review committee.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No