Symptomatic Irreversible Pulpitis
Conditions
Keywords
lidocaine, buffered, local anesthetic, irreversible pulpitis
Brief summary
The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.
Detailed description
40 subjects with a mandibular molar diagnosed with symptomatic irreversible pulpitis will be randomly allocated into 2 groups. One group will receive a total of 3 cartridges of a standard, unbuffered 2% lidocaine with 1:100,000 epinephrine via inferior alveolar nerve block (IANB) followed by supplemental buccal and lingual infiltrations, while the other will receive the equivalent yet buffered formulation. An electronic pulp tester (EPT) will be used to objectively determine baseline pulpal status of the affected tooth, followed by 2-minute interval testing following the administration of all local anesthesia. The onset of pulpal anesthesia is defined by the first of 2 consecutive EPT=80 readings, and the endodontic treatment may begin. Profound pulpal anesthesia is ultimately determined if the patients report a comfortable pulpotomy as reflected on the Wong-Baker FACES Visual Analog Scale.
Interventions
DRUGOnset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution
Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
Septodont's standard formulation of 2% lidocaine with epinephrine
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
A statistician will provide a two-product randomization scheme which will randomize each of the 40 subjects on the order of their entry into the study. The research assistants will be aware of and document this scheme, but the student researcher/PI will not know what type of anesthetic will be administered.
Intervention model description
This study will be a single-center, controlled, randomized, double-blind (provider and subject), 2 treatment, 1 period, parallel study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
- In order to participate, subjects must: * Be between the ages of 18 and 80 years old * Have the ability and willingness to independently consent to treatment and study participation * Have an uncomplicated medical history (ASA I and II) * Not be pregnant * Have no allergies local anesthetics/sulfites (confirmed or self-reported) * Not be taking any medications that may affect the proper assessment of the anesthetic (no acetaminophen or short-acting NSAIDs such as ibuprofen within the previous 6 hours; no long-acting NSAIDs such as naproxen within the previous 16 hours) * Not require nitrous oxide during treatment, and the injection area should appear healthy with no other pre-existing conditions or infections that may compromise an accurate collection of data * Be experiencing signs of irreversible pulpitis (an exaggerated response to cold that lingers longer than 10 seconds) in a mandibular molar at the time of conducting the study
Exclusion criteria
- No subjects will have: * A negative response to cold in the proposed treatment tooth * A radiographic periradicular pathosis more advanced than a widened periodontal ligament or have an intraoral swelling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS Scores as Measures of Profoundness of Pulpal Anesthesia | Up to 20 minutes post-drug administration | The mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be comfortable and profound. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset of Pulpal Anesthesia | Up to 20 minutes post-drug administration | Duration of time in minutes required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (which is the maximum stimulation). Any EPT score between 1-79 after 20 minutes post-anesthesia is considered a failure of pulpal anesthesia. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buffered 2% Lidocaine With 1:100,000 Epinephrine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine | 20 |
| Unbuffered 2% Lidocaine With 1:100,000 Epinephrine Standard local anesthetic
2% lidocaine with 1:100,000 epinephrine: Septodont's standard formulation of 2% lidocaine with epinephrine | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Buffered 2% Lidocaine With 1:100,000 Epinephrine | Unbuffered 2% Lidocaine With 1:100,000 Epinephrine | Total |
|---|---|---|---|
| Age, Continuous | 41.2 Years STANDARD_DEVIATION 13.5 | 38 Years STANDARD_DEVIATION 19.4 | 39.6 Years STANDARD_DEVIATION 16.6 |
| Initial Electronic Pulp Test (EPT) less than 80 shows vital pulp (min stimulation is 1, max is 80) | 42.9 Units on a scale | 47.3 Units on a scale | 45.1 Units on a scale |
| Initial Visual Analog Scale (VAS) w/ a min score of 1 and max score of 10 (a 4+ is significant pain) | 7.8 Units on a Scale | 6.9 Units on a Scale | 7.35 Units on a Scale |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 15 Participants | 8 Participants | 23 Participants |
| Sex: Female, Male Male | 5 Participants | 12 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
VAS Scores as Measures of Profoundness of Pulpal Anesthesia
The mean Visual Analog Scale (VAS) score, which ranges from a min of 1 to a max of 10. In other words, inadequate anesthesia is considered to be a VAS score that is between 4 and 10 because that is not considered to be comfortable and profound.
Time frame: Up to 20 minutes post-drug administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Buffered 2% Lidocaine With 1:100,000 Epinephrine | VAS Scores as Measures of Profoundness of Pulpal Anesthesia | 3.1 Score on a scale |
| Unbuffered 2% Lidocaine With 1:100,000 Epinephrine | VAS Scores as Measures of Profoundness of Pulpal Anesthesia | 1.2 Score on a scale |
Secondary
Onset of Pulpal Anesthesia
Duration of time in minutes required to achieve pulpal anesthesia, defined as an electrical pulp test score of 80 (which is the maximum stimulation). Any EPT score between 1-79 after 20 minutes post-anesthesia is considered a failure of pulpal anesthesia.
Time frame: Up to 20 minutes post-drug administration
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Buffered 2% Lidocaine With 1:100,000 Epinephrine | Onset of Pulpal Anesthesia | 8.4 Minutes |
| Unbuffered 2% Lidocaine With 1:100,000 Epinephrine | Onset of Pulpal Anesthesia | 8.8 Minutes |