Bite Force Measurements

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorRutgers, The State University of New Jersey

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

112 Participants
are grouped into 4 trial groups
Group A: Healthy Controls
Group B: Affected Pulp/Healthy Apex
Group C: Diseased Pulp/ Healthy Apex
Group D: Diseased Pulp/Diseased Apex

Trial outcomes

Primary outcomes

1

Mechanical Allodynia

Ipsilateral full arch and tooth specific bite-force

Time frame
Baseline
2

Mechanical Allodynia

Ipsilateral full arch and tooth specific bite-force

Time frame
10 minutes post-local anesthesia
3

Central Sensitization

Contralateral tooth specific bite-force

Time frame
Baseline
4

Central Sensitization

Contralateral tooth specific bite-force

Time frame
10 minutes post-local anesthesia

Secondary outcomes

1

Assessment of tooth vitality

Cold Test and Electric Pulp Test

Time frame
Baseline
2

Assessment of tooth vitality

Cold Test and Electric Pulp Test

Time frame
10 minutes post-local anesthesia
3

Numerical Pain Rating Score

Patient-reported pain on 0-10 scale

Time frame
Baseline
4

Numerical Pain Rating Score

Patient-reported pain on 0-10 scale

Time frame
10 minutes post-local anesthesia

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rutgers, The State University of New Jersey

Lead sponsor

New Jersey Alliance for Clinical and Translational Science

Collaborator