Anesthetic Effectiveness
Conditions
Keywords
degree of pulpal anesthesia obtained, primary infiltration in the lower first molar
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 the tooth as a supplemental injection, works very well following a typical inferior alveolar (lower jaw) nerve block. No study has compared 4% articaine with 1:100,000 epinephrine, 4% prilocaine with 1:200,000 epinephrine, and 4% lidocaine with 1:100,000 epinephrine in mandibular (lower jaw) infiltration injections of the first molar. The purpose of this prospective, randomized, double-blind, crossover study is to compare the degree of anesthesia obtained from the three solutions as a primary infiltration injection next to the mandibular first molar. The investigators also will record the pain of injection and postoperative pain.
Detailed description
Using a crossover design, 60 adult subjects will receive three injections consisting of a primary mandibular first molar infiltration of 1.8 mL of 4% articaine with 1:100,000 epinephrine, 1.8 mL of 4% prilocaine with 1:200,000 epinephrine, and 1.8 mL of 4% lidocaine with 1:100,000 epinephrine in three separate appointments spaced at least one week apart. With the crossover design, 180 infiltrations will be given for the first molar and each subject will serve as his or her own control. Ninety infiltrations will be administered on the mandibular left side and ninety administered on the mandibular right side. The order of the three 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 will be used to test the lower back teeth (molars and premolars) for anesthesia in 3-minute time intervals for a total of 60 minutes. The pain of injection and postoperative pain will be recorded in a survey. The data will be statistically analyzed.
Interventions
PROCEDUREMandibular buccal Infiltration injection
Sponsors
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* between the ages of 18 and 65 years. * in good health (ASA classification II or lower). * able to provide informed consent.
Exclusion criteria
* allergy to articaine, lidocaine or prilocaine. * history of significant medical problems (ASA classification III or greater). * depression (taking tri-cyclic antidepressant medications to control). * have taken 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 |
|---|---|---|
| Successful Pulpal Anesthesia. | 60 minutes | Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester. |
Countries
United States
Participant flow
Recruitment details
Recruitment at the College of Dentistry between May 2012 and December 2012.
Pre-assignment details
No exclusions. All subjects enrolled were utilized and assigned.
Participants by arm
| Arm | Count |
|---|---|
| Subjects Receiving Injections All subjects received each of the three anesthetic injections. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Subjects Receiving Injections |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 60 Participants |
| Age Continuous | 25.8 years STANDARD_DEVIATION 2.5 |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
Outcome results
Primary
Successful Pulpal Anesthesia.
Two consecutive 80/80 readings (no patient response) during 60 minutes of testing with an electric pulp tester.
Time frame: 60 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 4% Articaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | First Premolar | 29 participants |
| 4% Articaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | First Molar | 33 participants |
| 4% Articaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | Second Premolar | 32 participants |
| 4% Articaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | Second Molar | 37 participants |
| 4% Lidocaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | Second Premolar | 21 participants |
| 4% Lidocaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | Second Molar | 27 participants |
| 4% Lidocaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | First Molar | 20 participants |
| 4% Lidocaine With 1:100,000 Epinephrine | Successful Pulpal Anesthesia. | First Premolar | 24 participants |
| 4% Prilocaine With 1:200,000 Epinephrine | Successful Pulpal Anesthesia. | First Molar | 19 participants |
| 4% Prilocaine With 1:200,000 Epinephrine | Successful Pulpal Anesthesia. | Second Premolar | 17 participants |
| 4% Prilocaine With 1:200,000 Epinephrine | Successful Pulpal Anesthesia. | Second Molar | 22 participants |
| 4% Prilocaine With 1:200,000 Epinephrine | Successful Pulpal Anesthesia. | First Premolar | 18 participants |