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RecruitingNCT05351099Updated Feb 28, 2025

Dental Block for Pain Relief in ED Dental Pain Patients

An observational study in Dental Pain, sponsored by University of California, San Francisco. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.

Sponsored by University of California, San Francisco · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 8 months ago, but the record still lists the study as recruiting.
  • Started Mar 2022; still recruiting 4 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
195
Ages
18 Years and older
Sex
All
01

Study summary

This will be a prospective, observational cohort study assessing immediate pain relief from dental block in ED patients presenting with dental pain. The study will be conducted in the Community Regional Medical Center ED. The aim of this study, then, is to prospectively determine if dental block provides minimal clinically important difference in pain relief to these patients.

Read the detailed description

Patients will be provided written and verbal information about the study. If the patient does not agree to be enrolled in the study at that time, the patient will be asked to give the reason for refusing enrollment. The answer will be recorded without patient identifiers.

Dental blocks will be done by EM faculty or residents, physician assistants, and nurse practitioners who are not necessarily study personnel as dental block is routinely done in the ED as standard of care. Dental block will not be performed by medical students or off-service rotating residents.

Currently, providers are asked to undergo a short training session on how to administer a dental block. The training covers:

  • Each type of nerve block and indication
  • Equipment
  • Safety
  • Methods to prevent intra-arterial injection
  • Methods to prevent nerve injury

The education session participation will be tracked by Qualtrics.

Study protocol

  • Patient identified as potential enrollee
  • Research associate will examine the track board to see if "Dental Pain" or other dental complaint is listed for the patient. Research associate will then discuss with the practitioner responsible for the patient whether the patient is a candidate for the study.
  • Practitioners may also identify a patient appropriate for the study and inform the research associate
  • Research personnel works with the Practitioner evaluating patient and asks practitioner questions regarding the inclusion and exclusion criteria
  • If patient meets inclusion criteria and has no exclusion criteria, the research personnel will have the practitioner sign the "Inclusion/Exclusion Criteria" form attesting to this
  • If there are exclusion criteria, this is noted on the "Inclusion/Exclusion Criteria" form (with no patient identifying information) and paper is put in the research file
  • The provider will then ask the patient's permission to be approached about the study before the research associate approaches the patient
  • Research personnel discusses the study with the patient
  • Gives brief intro about the study and its purpose using the Study Participant Information Sheet and gets verbal consent to proceed
  • If patient refuses to be in the study, the research personnel asks the patient if he/she would be willing to fill out the "Reasons that patient meeting inclusion criteria is refusing enrollment" questionnaire, which is at the bottom of the "Inclusion/Exclusion Criteria" form
  • Research personnel completes the "Patient characteristics" form with the help of the practitioner and the patient.
  • The form records demographics, physical/history features, and initial pain VAS
  • Research personnel completes the "Dental Block Procedure Form" and uses it as a guide for the dental block procedure
  • The ED practitioner performs the dental block
  • Standardized equipment will be the following
  • 3-ml syringe
  • Standard 27-gauge needle
  • Standardized local anesthetic: Bupivacaine 0.5%
  • Standardized initial anesthetic amount for each anatomic location
  • Inferior alveolar: 3 mL
  • Posterior superior alveolar: 3 mL
  • Supraperiosteal: 2 mL
  • Research personnel starts the 10-minute clock with the administration of the dental block
  • After 10 minutes, research personnel records the pain VAS for the patient on the Dental Block Procedure form
  • If the practitioner feels that the local anesthetic effect is not sufficient, that practitioner may give further anesthetic as needed
  • The practitioner will still use the standardized equipment and local anesthetic
  • Research personnel starts the 10-minute clock
  • After 10 minutes, research personnel records the pain VAS for the patient on the "Dental Block Procedure" form
  • Repeat this procedure as needed if the practitioner feels another dental block injection is necessary
  • If repeated, this is noted on the form and pain VAS is listed again
  • When the practitioner has made the decision to not give any further dental injection
  • Research personnel, in consultation with the practitioner, completes the "Dental Block Procedure" form
  • Research personnel has patient fill out the portion on the "Dental Block Procedure" form that asks:
  • Would you have dental block procedure done again?
02

Conditions studied

  • Dental Pain

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Keywords

  • Dental Block
  • Inferior alveolar nerve block
  • Posterior superior alveolar nerve block
  • supraperiosteal nerve block
03

In context

Toothache

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's planned enrollment of 195 is above the median of 100 across 15 observational studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.

Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (aged 18-years or older) presenting to the ED with dental pain in whom the ED practitioner plans to perform a dental nerve block will be enrolled. Enrollment will occur 24 hours a day during all days of the week. Patients meeting eligibility criteria will be assessed for inclusion/exclusion criteria. There will be 195 patients enrolled in the study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients (>= 18-years-old) presenting to Community Regional Medical Center emergency department with a complaint of dental pain in whom the ED practitioner plans to perform a dental nerve block

Exclusion criteria

Exclusion Criteria:

  • Patient with previous dental block within 24 hours prior to arrival at the ED
  • Refusal of dental block
  • Patient in law enforcement custody
  • Patient unable to be properly informed of study purpose or able to complete pain VAS score due to physical/ mental condition (altered mental status, unstable psychiatric patient)
  • Patient unable to be properly informed of study purpose or able to complete pain VAS score due to language barrier (not English- or Spanish-speaking)
  • Patient with other acute non-dental painful condition making evaluation of dental pain severity vs non-dental pain severity not possible
  • Patient with pain in multiple areas of mouth needing dental block in > 1 anatomic area
  • Patient to have Dental / OMFS ED consult for procedure
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
195 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Change in Pain Scores on the Visual Analog Scale (VAS)

    Pre and Post Procedure Pain Scores will be measured on a VAS line comparing pre and post measurements from left to right. Left side indicating no pain all the way to the right indicating a pain score of 10.

    Time frame: Baseline10 minutes

Secondary outcomes

  1. Percentage of patients who would have procedure done again

    Follow-up survey to determine if patient would have the procedure done again

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2022 (actual). Primary completion is estimated for Mar 2026, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2022
First posted
Apr 28, 2022
StartActual
Mar 11, 2022
Primary completionEst.
Mar 11, 2026
CompletionEst.
Mar 11, 2026
Last update
Feb 28, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05351099
Responsible party
Sponsor
First posted
Apr 28, 2022
Start date
Mar 11, 2022
Primary completion
Mar 11, 2026 (estimated)
Completion
Mar 11, 2026 (estimated)
Last update
Feb 28, 2025

Study contacts

Brian Chinnock, MD
Contact
brian.chinnock@ucsf.edu
559-499-6440
Jannet Castaneda, BA
Contact
jannet.castanedasanchez@ucsf.edu
559-994-5893
Brian Chinnock, MD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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