Anesthetic Effectiveness
Conditions
Keywords
Degree of pulpal anesthesia obtained., Primary infiltration in the lower first molar., Buffered local anesthetic.
Brief summary
Infiltration (injecting next to the tooth) injections are common in dentistry and a number of studies have shown that articaine anesthetic, when injected next to a lower molar, is more effective than a local anesthetic injection of lidocaine. However success rates have not been as high as hoped for. No objective study has addressed the success rate of buffering articaine in a mandibular primary buccal infiltration of the first molar. Therefore, the purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of pulpal anesthesia obtained with a buffered 4% articaine with 1:100,000 epinephrine solution versus a non-buffered 4% articaine with 1:100,000 epinephrine solution as a primary infiltration in the mandibular first molar. The investigators will also record the pain of injection and postoperative pain.
Detailed description
Using a crossover design, 80 adult subjects will receive two injections consisting of a primary mandibular first molar infiltration of 1.8 mL of non-buffered 4% articaine with 1:100,000 epinephrine, and 1.8 mL of buffered 4% articaine with 1:100,000 in two separate appointments spaced at least one week apart. With the crossover design, 160 infiltrations will be given for the first molar and each subject will serve as his or her own control. Eighty infiltrations will be administered on the mandibular left side and 80 administered on the mandibular right side. The order of the two injections will be assigned randomly and the dentist and subject will be blinded about which anesthetic the subject is given. The anesthetics used in this study are not experimental. An electric pulp tester (EPT) will be used to test the lower first molar for anesthesia starting 30 seconds after the injection; and testing every 30 seconds for the first five minutes. After five minutes the EPT will be used to test the lower first molar every minute and the contralateral control canine every 5 minutes for a grand total of sixty minutes. The pain of injection and postoperative pain will be recorded in a survey. Patients will report any postoperative pain or discomfort on a Visual Analog Scale (VAS) for three days following each appointment. The data will be statistically analyzed.
Interventions
DRUGBuffered Articaine Hydrochloride + Epinephrine
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Between the age of 18-65 years. * in good health (ASA classification II or higher). * able to provide informed consent.
Exclusion criteria
* allergy to articaine. * history of significant medical problems (ASA classification of III or worse). * diagnosed depression (taking tri-cyclic antidepressant medications to control). * have taken central nervous system (CNS) depressants (including alcohol or any analgesic medications) within the last 48 hours prior to testing. * lactating or pregnant. * inability to give informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Pulpal Anesthesia. | 60 minutes per injection sequence. | An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success. |
Countries
United States
Participant flow
Recruitment details
80 subjects will be recruited in this crossover study. Each of the subjects will receive the injection regimens at 2 separate appointments spaced at least 2 weeks apart.
Participants by arm
| Arm | Count |
|---|---|
| Articaine Subjects receiving articaine injection. | 80 |
| Total | 80 |
Baseline characteristics
| Characteristic | Articaine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 80 Participants |
| Age, Continuous | 25.3 years STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 80 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 80 | 0 / 80 |
| serious Total, serious adverse events | 0 / 80 | 0 / 80 |
Outcome results
Primary
Number of Participants Achieving Pulpal Anesthesia.
An electric pulp tester will be used to test the lower jaw teeth (molars, premolars, and incisors) for anesthesia (numbness) in 4-minute time cycles for 60 minutes. Measurements of less than 80 on the EPT is considered not numb (anesthesia failure). Readings of 80 equate to anesthetic success.
Time frame: 60 minutes per injection sequence.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Articaine | Number of Participants Achieving Pulpal Anesthesia. | 52 Participants |
| Buffered Articaine | Number of Participants Achieving Pulpal Anesthesia. | 57 Participants |