NCT05351099

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2026

Completed
Last Updated

February 28, 2025

Status Verified

February 1, 2025

Enrollment Period

4 years

First QC Date

April 11, 2022

Last Update Submit

February 25, 2025

Conditions

Keywords

Dental BlockInferior alveolar nerve blockPosterior superior alveolar nerve blocksupraperiosteal nerve block

Outcome Measures

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.

    Baseline10 minutes

Secondary Outcomes (1)

  • Percentage of patients who would have procedure done again

    10 minutes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Regional Trauma and Burn Center

Fresno, California, 93721, United States

RECRUITING

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Chinnock, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 28, 2022

Study Start

March 11, 2022

Primary Completion

March 11, 2026

Study Completion

March 11, 2026

Last Updated

February 28, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations