Phase 4
N=40
Buffered vs. Unbuffered Local Anesthesia in Mandibular Molars Diagnosed With Symptomatic Irreversible Pulpitis
Symptomatic Irreversible Pulpitis
Bottom Line
View on ClinicalTrials.gov: NCT05227300 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: VAS Scores as Measures of Profoundness of Pulpal Anesthesia — 3.1; 1.2 Score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing Additive Solution (Drug); 2% lidocaine with 1:100,000 epinephrine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY VAS Scores as Measures of Profoundness of Pulpal Anesthesia |
3.1; 1.2 | — |
| SECONDARY Onset of Pulpal Anesthesia |
8.4; 8.8 | — |
Summary
The purpose of this study is to determine whether one type of anesthetic (numbing medicine) will work better at numbing the nerve in a tooth than using a different type of anesthetic. A second purpose is to see if the time needed to numb the nerve in a tooth is different between the two anesthetics.
Eligibility Criteria
Inclusion Criteria - In order to participate, subjects must:
- 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 - No subjects will have:
- 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
Data sourced from ClinicalTrials.gov (NCT05227300). 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.