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Clinical Trials/NCT06526572
NCT06526572
Recruiting
N/A

Measuring Pain Perception in Patients With Symptomatic Acute Pulpitis and Resistant to Inferior Alveolar Nerve Block Using NRS and Brain Waves

Cleveland Dental Institute1 site in 1 country50 target enrollmentJuly 1, 2023
ConditionsAcute Pulpitis

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acute Pulpitis
Sponsor
Cleveland Dental Institute
Enrollment
50
Locations
1
Primary Endpoint
Electroencephalography (EEG)
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of the proposed study is to investigate and comprehensively understand pain perception in patients diagnosed with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB).

The study aims to achieve this by utilizing a dual approach that combines subjective self-reporting of pain intensity using the Numeric Rating Scale (NRS) with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).

By integrating these two methods, the study seeks to explore potential correlations between self-reported pain scores and neural responses recorded through EEG, providing insights into the pain experience of this specific patient population.

Ultimately, the goal of the study is to enhance the understanding of pain perception mechanisms in individuals with symptomatic acute pulpitis resistant to IANB and potentially guide the development of more effective and personalized pain management strategies for these patients.

Registry
clinicaltrials.gov
Start Date
July 1, 2023
End Date
January 31, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Cleveland Dental Institute
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adults aged \[18-50 years\]. Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings.
  • Demonstrates resistance to inferior alveolar nerve block (IANB). Willing and able to provide informed consent to participate in the study. Able to communicate effectively in the language used for study procedures.

Exclusion Criteria

  • Individuals with known neurological or psychiatric disorders affecting pain perception.
  • Pregnant individuals or those breastfeeding at the time of the study. History of severe allergies or adverse reactions to local anesthetics or EEG gel.
  • Presence of significant medical conditions that may contraindicate dental procedures or EEG recordings.
  • Individuals taking medications that could significantly affect pain perception (e.g., strong analgesics, sedatives).
  • Any contraindications for dental procedures or EEG recordings as determined by the study's dental and medical professionals.
  • Inability to understand and follow study instructions.

Outcomes

Primary Outcomes

Electroencephalography (EEG)

Time Frame: 3 months

Changes in alpha brain waves in patients with acute pulpitis and resistant to alveolar nerve block injection

Numerical Rate Scale (NRS)

Time Frame: 3 months

Measuring pain perception using NRS (Scale 0-10 where 0 is no pain and 10 is the most unbearable pain) in patients with acute pulpitis and resistant to alveolar nerve block injection.

Study Sites (1)

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