Irreversible PulpitisNCT06843525
Bite Force Measurements
An observational study of Irreversible Pulpitis and Apical Periodontitis, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Irreversible Pulpitis, Apical Periodontitis, Pulpal Necrosis
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 16 May 2025to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers School of Dental Medicine
Newark, New Jersey, 07103
Vanessa Chrepa, DDS,MS, PhD, 973-972-7331, vanessa.chrepa@rutgers.edu
Gayathri Subramanian, DMD, PhD, 973-972-2444, subramga@sdm.rutgers.edu
About this study
Official title: 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).
Read the 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.
- Conditions
- Irreversible Pulpitis, Apical Periodontitis, Pulpal Necrosis
- Medical subject headings
- Periapical Periodontitis, Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Mechanical Allodynia
Ipsilateral full arch and tooth specific bite-force
Measured: Baseline
Mechanical Allodynia
Ipsilateral full arch and tooth specific bite-force
Measured: 10 minutes post-local anesthesia
Central Sensitization
Contralateral tooth specific bite-force
Measured: Baseline
Central Sensitization
Contralateral tooth specific bite-force
Measured: 10 minutes post-local anesthesia
Secondary outcomes (4)
Assessment of tooth vitality
Cold Test and Electric Pulp Test
Measured: Baseline
Assessment of tooth vitality
Cold Test and Electric Pulp Test
Measured: 10 minutes post-local anesthesia
Numerical Pain Rating Score
Patient-reported pain on 0-10 scale
Measured: Baseline
Numerical Pain Rating Score
Patient-reported pain on 0-10 scale
Measured: 10 minutes post-local anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start16 May 2025
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Alliance for Clinical and Translational Science
- Responsible party
- Principal investigator, Gayathri Subramanian, Rutgers, The State University of New Jersey
- Investigators
- Varvara Vanessa Chrepa, DDS, MS, PhD, Principal investigator, Rutgers School of Dental MedicineGayathri Subramanian, PhD, DMD, Principal investigator, Rutgers School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843525
- Sponsor's protocol ID
- Pro2024002660
- Status last verified
- Jul 2025
- First submitted
- 20 Feb 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring a Neuropathic Basis for Acute Pulpal Pain- a Clinical Pilot
- ClinicalTrials.gov ID
- NCT06843525
- Acronym / sponsor ID
- Pro2024002660
- Conditions
- Irreversible Pulpitis, Apical Periodontitis, Pulpal Necrosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- New Jersey Alliance for Clinical and Translational Science
- Study start
- 16 May 2025 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mechanical Allodynia
Time frame: Baseline
Ipsilateral full arch and tooth specific bite-force
Mechanical Allodynia
Time frame: 10 minutes post-local anesthesia
Ipsilateral full arch and tooth specific bite-force
Central Sensitization
Time frame: Baseline
Contralateral tooth specific bite-force
Central Sensitization
Time frame: 10 minutes post-local anesthesia
Contralateral tooth specific bite-force
4 secondary outcomes
Assessment of tooth vitality
Time frame: Baseline
Assessment of tooth vitality
Time frame: 10 minutes post-local anesthesia
Numerical Pain Rating Score
Time frame: Baseline
Numerical Pain Rating Score
Time frame: 10 minutes post-local anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Varvara Vanessa Chrepa, DDS, MS, PhD principal investigator
Rutgers School of Dental Medicine
Gayathri Subramanian, PhD, DMD principal investigator
Rutgers School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irreversible Pulpitis and Apical Periodontitis, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gayathri D Subramanian, PhD, DMD (973 972 3418, subramga@sdm.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanical Allodynia (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.