Irreversible Pulpitis (Toothache)
Conditions
Brief summary
The purpose of this study is to determine the effect of buffered lidocaine (a numbing solution) on the ability to numb patients with toothaches. Buffered anesthetic (numbing) solutions have shown promise in some medical and dental research. Patients presenting with toothaches will be given either a buffered numbing solution or a nonbuffered numbing solution. Neither the patient nor the operator will know which solution they will receive. Root canal treatment will be performed on the tooth and the ability of the buffered versus non-buffered numbing solutions will be compared.
Interventions
DRUGnonbuffered lidocaine
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* patients with a diagnosis of irreversible pulpitis (toothache) in a mandibular posterior tooth (back/bottom tooth) with moderate to severe pain * ages 18 -65 years of age * in good health (ASA I or II) * able to grant informed consent.
Exclusion criteria
* allergy to lidocaine (numbing solution * significant medical problem (ASA III or IV) * have taken CNS depressants or analgesic medications within the last 24 hours * pregnancy or lactating * non-English speaking * inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia) | pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection | — |
| Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis. | approximately 15 minutes after injection | 100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Buffered buffered lidocaine | 50 |
| Nonbuffered nonbuffered lidocaine | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Buffered | Nonbuffered | Total |
|---|---|---|---|
| Age, Continuous | 34.8 years STANDARD_DEVIATION 11.3 | 35.5 years STANDARD_DEVIATION 10.7 | 35.1 years STANDARD_DEVIATION 11 |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 32 Participants | 29 Participants | 61 Participants |
| Sex: Female, Male Male | 18 Participants | 21 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis.
100 patients diagnosed with symptomatic irreversible pulpitis of a mandibular posterior tooth randomly received a conventional inferior alveolar nerve block (IAN) block using either 2.8 ml of 4% lidocaine with 1:100,000 epinephrine or 2.8 ml of 4% lidocaine with 1:100,000 epinephrine buffered with sodium bicarbonate in a double-blind manner. For the buffered solution, each cartridge was buffered with 8.4% sodium bicarbonate to produce a final concentration of 0.18 mEq/mL of sodium bicarbonate. Fifteen minutes after administration of the IAN block, profound lip numbness was confirmed and endodontic access was initiated. Success was determined as no or mild pain on access or instrumentation of the root canal. Higher numbers on the VAS are indicative of more pain and less success and the VAS scale ranged from 0 to 170 mm.
Time frame: approximately 15 minutes after injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Buffered Lidocaine | Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis. | 32 percentage of participants |
| Nonbuffered Lidocaine | Effect of Buffered Lidocaine on the Success of the Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis. | 40 percentage of participants |
Primary
Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia)
Time frame: pain at time of treatment (after buffered versus nonbuffered numbing solution) average of 15 minutes after injection
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Buffered Lidocaine | Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia) | 16 Participants |
| Nonbuffered Lidocaine | Percent of Patients With Successful Anesthesia (% of Patients Able to Have Treatment Without Additional Anesthesia) | 20 Participants |