Pain Measured by NRS and EEG in Acute Pulpitis

July 29, 2024 updated by: Cleveland Dental Institute

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44128
        • Recruiting
        • Cleveland Dental Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ahmed Basyoni, resident
        • Sub-Investigator:
          • Abdelrahman Zaghloul, resident
        • Principal Investigator:
          • Ahmed Hashem, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adults male or females aged [18-50 years], Clinically diagnosed with symptomatic acute pulpitis based on dental examination and radiographic findings. They are medically free. They are willing and able to provide informed consent to participate in the study. They are able to communicate effectively in the language used for study procedures.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
symptomatic acute pulpitis
Patients with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB)
Diagnostic test: Brain wave analysis using electroencephalography (EEG).
Asessment of pain with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).
Diagnostic test: Numerical rate Scale (NRS)
Asessment of pain with the subjective numercal rate scale method (NRS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electroencephalography (EEG)
Time Frame: 3 months
Changes in alpha brain waves in patients with acute pulpitis and resistant to alveolar nerve block injection
3 months
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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Dental Institute

Investigators

  • Study Director: Ahmed A hashem, PhD, CDI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 24, 2024

First Posted (Actual)

July 30, 2024

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDIENDO0007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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