Phase 4
N=80
Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.
Anesthetic Effectiveness
Bottom Line
View on ClinicalTrials.gov: NCT01862614 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Participants Achieving Pulpal Anesthesia. — 52; 57 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Articaine Hydrochloride + Epinephrine (Drug); Buffered Articaine Hydrochloride + Epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ohio State University
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Pulpal Anesthesia. |
52; 57 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01862614). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.