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NCT Number: NCT06526572

Pain Measured by NRS and EEG in Acute Pulpitis

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Dental Institute

Cleveland, Ohio, 44128, United States

Location status: Recruiting

Location contact

Abdelrahman Zaghloul, resident

SUB_INVESTIGATOR

Ahmed A Hashem, Profesor

CONTACT

[email protected]

440-502-1591

Ahmed Basyoni, resident

SUB_INVESTIGATOR

Ahmed Hashem, Prof.

PRINCIPAL_INVESTIGATOR

Waleed Elmallah, PhD

CONTACT

[email protected]

2163336695

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brain wave analysis using electroencephalography (EEG).

Diagnostic Test

Asessment of pain with objective neurophysiological assessment through brain wave analysis using electroencephalography (EEG).

Numerical rate Scale (NRS)

Diagnostic Test

Asessment of pain with the subjective numercal rate scale method (NRS

Primary outcomes

  1. Electroencephalography (EEG)

    Time frame: 3 months

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

  2. 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 contacts

Contact information is provided by the study sponsor or research team.

Abdelrahman Zaghloul

CONTACT

[email protected]

9016324289

Ahmed I Basyoni

CONTACT

[email protected]

3612290038

Sponsors and collaborators

Lead sponsor

Cleveland Dental Institute

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 30, 2024
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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