Symptomatic Irreversible Pulpitis
Conditions
Keywords
lidocaine, articaine, mepivacaine, buffered local anesthetic, irreversible pulpitis
Brief summary
The purpose of this study is to determine whether a combination of anesthetics (numbing medicine) will adequately anesthetize teeth over a different combination. 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
60 human subjects with Symptomatic Irreversible Pulpitis (SIP) in mandibular molars will be randomly allocated into 2 groups. One group will receive a combination of: 1 cartridge of buffered 2% lidocaine w/ 1:100k epi via inferior alveolar nerve block (IANB) followed by 1 cartridge of 3% mepivacaine via IANB. This will be followed by 0.5 cartridges (0.9mL) of buffered 4% articaine with 1:100k epi via buccal infiltration and 0.5 cartridges of buffered 4% articaine with 1:100k epi via lingual infiltration. All IANB injections will include a lingual block. The second group will be provided an unbuffered version of the same combination. An electronic pulp tester (EPT) will be used to determine the vitality of the treated tooth. Endodontic treatment will be initiated after two consecutive EPT readings of 80, displaying pulpal anesthesia. Profound pulpal anesthesia is described by the patient's report on the visual analog scale after the pulpotomy.
Interventions
DRUGSodium bicarbonate
Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
DRUGLidocaine w/ epi
Septodont's standard formulation of 2% lidocaine with epinephrine
DRUGArticaine w/ epi
Septodont's standard formulation of 4% articaine with epinephrine
DRUGMepivacaine plain
Septodont's standard formulation of 3% mepivacaine
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 60 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
* 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
* 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 |
|---|---|---|
| Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia | Up to 20 minutes post-drug administration | Patient will report their comfort during treatment based on a visual analogue scale (VAS) graphic. Visual analog scale (VAS) is based on a scale of 0-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment indicating there was inadequate anesthesia. A VAS score of 0 indicates no pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Time to Profound Pulpal Anesthesia | Up to 15 minutes post-drug administration | An electronic pulp tester will be used to assess anesthesia after anesthetic is administered. The median time needed to achieve profound pulpal anesthesia for the two groups will be calculated using the Kaplan-Meier method and compared with a log-rank test, with patients who failed to achieve profound pulpal anesthesia censored at 15 minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buffered Buffered 2% lidocaine with 1:100,000 epinephrine Buffered 4% articaine with 1:100,000 epinephrine Buffered 3% mepivacaine Buffered local anesthetic (addition of sodium bicarbonate to make a 10% buffered solution)
Sodium bicarbonate: Onpharma's Onset sodium bicarbonate buffer to be added to a standard cartridge of dental local anesthetic
Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine
Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine
Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine | 20 |
| Unbuffered Unbuffered 2% lidocaine with 1:100,000 epinephrine Unbuffered 4% articaine with 1:100,000 epinephrine Unbuffered 3% mepivacaine Standard local anesthetics
Lidocaine w/ epi: Septodont's standard formulation of 2% lidocaine with epinephrine
Articaine w/ epi: Septodont's standard formulation of 4% articaine with epinephrine
Mepivacaine plain: Septodont's standard formulation of 3% mepivacaine | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Unbuffered | Total | Buffered |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 40 Participants | 20 Participants |
| Age, Continuous | 28 years | 33.5 years | 39 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex: Female, Male Female | 13 Participants | 25 Participants | 12 Participants |
| Sex: Female, Male Male | 7 Participants | 15 Participants | 8 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
Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia
Patient will report their comfort during treatment based on a visual analogue scale (VAS) graphic. Visual analog scale (VAS) is based on a scale of 0-10 related to patient comfort. A VAS score of 10 would mean the patient was extremely uncomfortable during treatment indicating there was inadequate anesthesia. A VAS score of 0 indicates no pain.
Time frame: Up to 20 minutes post-drug administration
Population: Patients who achieved profound pulpal anesthesia
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Buffered | Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia | 0 units on a scale |
| Unbuffered | Median Visual Analogue Scale (VAS) Score as a Measure of Profoundness of Pulpal Anesthesia | 0 units on a scale |
p-value: 0.18Wilcoxon (Mann-Whitney)
Secondary
Median Time to Profound Pulpal Anesthesia
An electronic pulp tester will be used to assess anesthesia after anesthetic is administered. The median time needed to achieve profound pulpal anesthesia for the two groups will be calculated using the Kaplan-Meier method and compared with a log-rank test, with patients who failed to achieve profound pulpal anesthesia censored at 15 minutes.
Time frame: Up to 15 minutes post-drug administration
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Buffered | Median Time to Profound Pulpal Anesthesia | 5.28 minutes |
| Unbuffered | Median Time to Profound Pulpal Anesthesia | 7.96 minutes |
p-value: 0.09Log Rank