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NCT01862614 · ClinicalTrials.gov registry record · Phase 4
Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.
A Phase 4 study, sponsored by Ohio State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 80
- Enrollment target
NCT01862614: Completed Phase 4 study, sponsored by Ohio State University.
NCT01862614 is a Phase 4 study that has completed, run by Ohio State University. The registered enrollment target is 80 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01862614, a Phase 4 study, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 80 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Articaine Hydrochloride + Epinephrine
- DRUG Buffered Articaine Hydrochloride + Epinephrine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2013-04 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT01862614 record still lists
NCT01862614 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Articaine Hydrochloride + Epinephrine is the first listed.
NCT01862614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01862614 about?
NCT01862614 is a clinical study titled "Testing the Anesthetic Effectiveness of Buffered Articaine Injected Next to a Lower First Molar.". 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....
What is the current status of trial NCT01862614?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 80 participants. The study started on 2013-04. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01862614?
The interventions under investigation include: Articaine Hydrochloride + Epinephrine (DRUG), Buffered Articaine Hydrochloride + Epinephrine (DRUG).
Who is sponsoring clinical trial NCT01862614?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01862614's enrollment target sits among peer trials
80 946th of 2000 higher than 1,021 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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