Bite Force Measurements

NCT06843525 | Recruiting

• 1 other identifier: Pro2024002660
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Irreversible Pulpitis; Apical Periodontitis; Pulpal Necrosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Assessment of tooth vitality

  Baseline

• Assessment of tooth vitality

  10 minutes post-local anesthesia

• Numerical Pain Rating Score

  Baseline

• Numerical Pain Rating Score

  10 minutes post-local anesthesia

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• New Jersey Alliance for Clinical and Translational Science: collaborator

Study Sites (1)

Rutgers School of Dental Medicine

Newark, New Jersey, 07103, United States

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis; Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Dental Pulp Diseases; Tooth Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Varvara Vanessa Chrepa, DDS, MS, PhD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Gayathri Subramanian, PhD, DMD

  Rutgers School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gayathri D Subramanian, PhD, DMD

CONTACT

973 972 3418; subramga@sdm.rutgers.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: February 25, 2025
• Study Start: May 16, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: A year after completion of the study and data analysis
• 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.

Locations

US (1)