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Dental Block for Pain Relief in ED Dental Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05351099
Recruitment Status : Recruiting
First Posted : April 28, 2022
Last Update Posted : April 28, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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.

Condition or disease
Dental Pain

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Efficacy of ED Provider-Performed Dental Block for Pain Relief in Patients Presenting With Dental Pain
Actual Study Start Date : March 11, 2022
Estimated Primary Completion Date : March 11, 2025
Estimated Study Completion Date : March 11, 2026



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Percentage of patients who would have procedure done again [ Time Frame: 10 minutes ]
    Follow-up survey to determine if patient would have the procedure done again



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05351099


Contacts
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Contact: Brian Chinnock, MD 559-499-6440 brian.chinnock@ucsf.edu
Contact: Jannet Castaneda, BA 559-994-5893 jannet.castanedasanchez@ucsf.edu

Locations
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United States, California
Community Regional Trauma and Burn Center Recruiting
Fresno, California, United States, 93721
Contact: Brian Chinnock, MD    559-499-6400    brian.chinnock@ucsf.edu   
Contact: Jannet Castaneda, BA    559-499-6435    jannet.castanedasanchez@ucsf.edu   
Principal Investigator: Brian Chinnock, MD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Brian Chinnock, MD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05351099    
Other Study ID Numbers: 2021094
First Posted: April 28, 2022    Key Record Dates
Last Update Posted: April 28, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Dental Block
Inferior alveolar nerve block
Posterior superior alveolar nerve block
supraperiosteal nerve block
Additional relevant MeSH terms:
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Toothache
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations