Bite Force Measurements

July 22, 2025 updated by: Gayathri Subramanian, Rutgers, The State University of New Jersey

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Recruiting
        • Rutgers School of Dental Medicine
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vanessa Chrepa, DDS, MS, PhD
        • Principal Investigator:
          • Gayathri Subramanian, DMD, PhD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mechanical Allodynia
Time Frame: Baseline
Ipsilateral full arch and tooth specific bite-force
Baseline
Mechanical Allodynia
Time Frame: 10 minutes post-local anesthesia
Ipsilateral full arch and tooth specific bite-force
10 minutes post-local anesthesia
Central Sensitization
Time Frame: Baseline
Contralateral tooth specific bite-force
Baseline
Central Sensitization
Time Frame: 10 minutes post-local anesthesia
Contralateral tooth specific bite-force
10 minutes post-local anesthesia

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessment of tooth vitality
Time Frame: Baseline
Cold Test and Electric Pulp Test
Baseline
Assessment of tooth vitality
Time Frame: 10 minutes post-local anesthesia
Cold Test and Electric Pulp Test
10 minutes post-local anesthesia
Numerical Pain Rating Score
Time Frame: Baseline
Patient-reported pain on 0-10 scale
Baseline
Numerical Pain Rating Score
Time Frame: 10 minutes post-local anesthesia
Patient-reported pain on 0-10 scale
10 minutes post-local anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rutgers, The State University of New Jersey

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
New Jersey Alliance for Clinical and Translational Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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