Pain Measured by NRS and EEG in Acute Pulpitis

Recruiting

• Conditions: Acute Pulpitis
• Interventions: Diagnostic Test: Brain wave analysis using electroencephalography (EEG).; Diagnostic Test: Numerical rate Scale (NRS)

• Registration Number: NCT06526572
• Lead Sponsor: Cleveland Dental Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-24
• Last Update Submitted: 2024-07-29
• Study First Posted: 2024-07-30
• Last Update Posted: 2024-07-31
• Primary Completion: 2024-10-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
symptomatic acute pulpitis	Brain wave analysis using electroencephalography (EEG).	Patients with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB)
symptomatic acute pulpitis	Numerical rate Scale (NRS)	Patients with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB)

Primary Outcome Measures

Name	Time	Method
Electroencephalography (EEG)	3 months	Changes in alpha brain waves in patients with acute pulpitis and resistant to alveolar nerve block injection
Numerical Rate Scale (NRS)	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.

Trial Locations

Locations (1)

Cleveland Dental Institute; 🇺🇸 Cleveland, Ohio, United States