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.
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.
United States1 site, 1 recruiting
- 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
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.
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)
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.
- First posted28 Apr 2022
- Study start11 Mar 2022
- Primary completion11 Mar 2026 (estimated)
- Study completion11 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PainStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brian Chinnock, MD, Principal investigator, University of California, San Francisco
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ED Provider-Performed Dental Block for Pain Relief in Patients Presenting With Dental Pain
- ClinicalTrials.gov ID
- NCT05351099
- Acronym / sponsor ID
- 2021094
- Conditions
- Dental Pain
- Keywords
- Dental Block, Inferior alveolar nerve block, Posterior superior alveolar nerve block, supraperiosteal nerve block
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 195 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 11 Mar 2022 (actual)
- Primary completion
- 11 Mar 2026 (estimated)
- Study completion
- 11 Mar 2026 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Pain Scores on the Visual Analog Scale (VAS)
Time frame: Baseline10 minutes
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.
1 secondary outcome
Percentage of patients who would have procedure done again
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Chinnock, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
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.