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Dental PainNCT05351099

Dental Block for Pain Relief in ED Dental Pain Patients

An observational study of Dental Pain, run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Dental Pain
How many people
195 participants
Where
1 siteUnited States
Study dates
11 Mar 2022to 11 Mar 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brian Chinnock, MD contact

559-499-6440

brian.chinnock@ucsf.edu

United States1 site, 1 recruiting
  • Community Regional Trauma and Burn Center

    Fresno, California, 93721

    Brian Chinnock, MD, 559-499-6400, brian.chinnock@ucsf.edu

    Jannet Castaneda, BA, 559-499-6435, jannet.castanedasanchez@ucsf.edu

    Recruiting

Other trials in United States

About this study

Official title: Efficacy of ED Provider-Performed Dental Block for Pain Relief in Patients Presenting With Dental Pain

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?
Conditions
Dental Pain
Keywords
Dental Block, Inferior alveolar nerve block, Posterior superior alveolar nerve block, supraperiosteal nerve block
Medical subject headings
Toothache

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline10 minutes

Secondary outcomes (1)
  1. Percentage of patients who would have procedure done again

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

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2022
  2. Study start11 Mar 2022
  3. Primary completion11 Mar 2026 (estimated)
  4. Study completion11 Mar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
195 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05351099
Sponsor's protocol ID
2021094
Status last verified
Feb 2025
First submitted
11 Apr 2022
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Dental Pain, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian Chinnock, MD (559-499-6440, brian.chinnock@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pain Scores on the Visual Analog Scale (VAS) (time frame: Baseline10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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