Actively Recruiting

Age: 18Years - 89Years
All Genders
ID06843525

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

Led by Rutgers, The State University of New Jersey · Updated on 2025-07-24

112

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

Sponsors

R

Rutgers, The State University of New Jersey

Lead Sponsor

N

New Jersey Alliance for Clinical and Translational Science

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the neuropathic mechanisms behind acute dental pain caused by untreated tooth decay, specifically focusing on conditions like irreversible pulpitis, apical periodontitis, and pulpal necrosis. The study aims to better understand how nerve and surrounding tissue involvement produces pain through mechanisms such as mechanical allodynia and central sensitization. By identifying these pain pathways, the research hopes to support new non-opioid pain treatments and reduce reliance on opioids, especially in emergency room settings where dental care access is limited. This observational study uses the FDA-approved Innobyte4 device to measure bite force and quantify mechanical pain thresholds in patients needing endodontic treatment (root canal therapy) on lower molar teeth. Participants include those requiring restoration on vital molars, with pulpal involvement, or with irreversible pulpitis or necrosis, sometimes accompanied by tenderness or radiographic signs of apical pathology. The study groups include healthy controls and varying stages of pulp and apex health or disease. Participants will undergo assessments including measurements of mechanical allodynia and central sensitization before and 10 minutes after local anesthesia, as well as evaluations of tooth vitality and pain rating scores. The study requires the presence of an opposing tooth and adequate contact for bite testing. Data collected will help validate neuropathic pain as a target for improved dental pain management. Total participation details and follow-up durations are not specified.

CONDITIONS

Brief Title

Bite Force Measurements

Who Can Participate

Age: 18Years - 89Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals 18 years or older
  • Require a filling on a vital lower 1st or 2nd molar tooth without extensive decay or previous root canal treatment
  • Require root canal treatment on a lower 1st or 2nd molar tooth
  • Opposing tooth present, symptom-free, with adequate tooth structure to make contact
  • Able to provide informed consent
  • English-speaking
Not Eligible

You will not qualify if you...

  • Prisoners, children, pregnant women, or patients with intellectual/cognitive disabilities
  • Taking prescription pain medications for chronic conditions
  • History of addiction or substance dependence
  • Swelling extending beyond the affected tooth
  • Currently on antibiotics for infection or swelling
  • Missing the complementary molar on the same or opposite side
  • Missing more than two teeth in a quadrant (excluding third molars)
  • Any other molar in the pair is painful to biting pressure or tapping
  • Taken pain medication within the last 6 hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Single day assessment

Participants undergo assessments to measure mechanical allodynia, central sensitization, tooth vitality, and pain ratings before and after local anesthesia.

1 visit (in-person)

Long-term Monitoring

Duration - Up to study completion

Participants are observed for changes in symptoms and any follow-up assessments as needed.

Additional visits depending on participant status

Trial Site Locations

Total: 1 location

1

Rutgers School of Dental Medicine

Newark, New Jersey, United States, 07103

Actively Recruiting

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Research Team

G

Gayathri D Subramanian, PhD, DMD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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