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Recruiting

NCT Number: NCT06843525

Bite Force Measurements

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).

Recruiting

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

Location status: Recruiting

Location contact

Gayathri Subramanian, DMD, PhD

CONTACT

[email protected]

973-972-2444

Gayathri Subramanian, DMD, PhD

PRINCIPAL_INVESTIGATOR

Vanessa Chrepa, DDS, MS, PhD

PRINCIPAL_INVESTIGATOR

Vanessa Chrepa, DDS,MS, PhD

CONTACT

[email protected]

973-972-7331

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mechanical Allodynia

    Time frame: Baseline

    Ipsilateral full arch and tooth specific bite-force

  2. Mechanical Allodynia

    Time frame: 10 minutes post-local anesthesia

    Ipsilateral full arch and tooth specific bite-force

  3. Central Sensitization

    Time frame: Baseline

    Contralateral tooth specific bite-force

  4. Central Sensitization

    Time frame: 10 minutes post-local anesthesia

    Contralateral tooth specific bite-force

Secondary outcomes

  1. Assessment of tooth vitality

    Time frame: Baseline

    Cold Test and Electric Pulp Test

  2. Assessment of tooth vitality

    Time frame: 10 minutes post-local anesthesia

    Cold Test and Electric Pulp Test

  3. Numerical Pain Rating Score

    Time frame: Baseline

    Patient-reported pain on 0-10 scale

  4. Numerical Pain Rating Score

    Time frame: 10 minutes post-local anesthesia

    Patient-reported pain on 0-10 scale

Study contacts

Contact information is provided by the study sponsor or research team.

Gayathri D Subramanian, PhD, DMD

CONTACT

[email protected]

973 972 3418

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Collaborators

  • New Jersey Alliance for Clinical and Translational Science

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 25, 2025
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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