Pain Measured by NRS and EEG in Acute Pulpitis

NCT ID: NCT06526572

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-01-31

Brief Summary

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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

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Conditions

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Acute Pulpitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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symptomatic acute pulpitis

Patients with symptomatic acute pulpitis who are resistant to inferior alveolar nerve block (IANB)

Brain wave analysis using electroencephalography (EEG).

Intervention Type DIAGNOSTIC_TEST

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

Numerical rate Scale (NRS)

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Brain wave analysis using electroencephalography (EEG).

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

Intervention Type DIAGNOSTIC_TEST

Numerical rate Scale (NRS)

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cleveland Dental Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ahmed A hashem, PhD

Role: STUDY_DIRECTOR

CDI

Locations

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Cleveland Dental Institute

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ahmed I Basyoni

Role: CONTACT

3612290038

Abdelrahman Zaghloul

Role: CONTACT

9016324289

Facility Contacts

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Ahmed A Hashem, Profesor

Role: primary

440-502-1591

Waleed Elmallah, PhD

Role: backup

2163336695

Other Identifiers

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CDIENDO0007

Identifier Type: -

Identifier Source: org_study_id

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