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NCT01622296 · ClinicalTrials.gov registry record · Phase 4
Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients
A Phase 4 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
NCT01622296: Completed Phase 4 study, sponsored by University of California, San Francisco.
NCT01622296 is a Phase 4 study that has completed, run by University of California, San Francisco. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01622296, a Phase 4 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the effectiveness of buffered local anesthesia injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine with sodium bicarbonate may reduce the pain of injection for both adults and children. In this study, the investigators will compare two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection. Hypothesis: Anesthetic buffered to physiologic pH will result in a less painful injection compared to the acidic alternative used in most dental offices. This can be demonstrated by comparing two local anesthetic preparations, a buffered anesthetic and the conventionally available anesthetic, for pain upon injection.
Primary Outcome
Two treatment visits were required for bilateral, mandibular dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The administering operator stepped out of the room after each injection was completed, and the participant was asked by a trained research assistant to record a visual analog scale (VAS) pain score. The VAS was used to assess pain sensitivity, and utilizes a 100mm horizontal line
Interventions
- DRUG Sodium bicarbonate
- DRUG Lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
What the finished NCT01622296 record still lists
NCT01622296 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Sodium bicarbonate is the first listed.
NCT01622296 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01622296 about?
NCT01622296 is a clinical study titled "Comparison of Pain of Conventional to Buffered Local Anesthesia During Injection in Pediatric Dental Patients". The purpose of this study is to determine the effectiveness of buffered local anesthesia injections to numb the gums and teeth during dental treatment. Adjusting the pH of lidocaine with sodium bicarbonate may reduce the pain of injection for both adults and children. In this study, the investigator...
What is the current status of trial NCT01622296?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2012-04. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01622296?
The interventions under investigation include: Sodium bicarbonate (DRUG), Lidocaine (DRUG).
Who is sponsoring clinical trial NCT01622296?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01622296's enrollment target sits among peer trials
20 1753rd of 2000 higher than 167 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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