Recruiting

Pain Assessment

Sponsor:

Cleveland Dental Institute

Code:

NCT06526572

Conditions

Acute Pulpitis

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Brain wave analysis using electroencephalography (EEG).

Numerical rate Scale (NRS)

Study Details

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.

Conditions

Acute Pulpitis

Study ID

NCT06526572

Start date

Jul 1, 2023

Status verified date

Jul, 2024

Completion date

Jan 31, 2025

Anticipated

Primary completion date

Oct 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

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

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

symptomatic acute pulpitis

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

Interventions

Brain wave analysis using electroencephalography (EEG).

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

Numerical rate Scale (NRS)

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

Primary outcome measure

  • Electroencephalography (EEG) [ Time Frame: 3 months ]
  • Numerical Rate Scale (NRS) [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Ahmed I Basyoni

3612290038a.basyoni@cdiohio.org

Abdelrahman Zaghloul

9016324289a.zaghloul@cdiohio.org

Locations

Cleveland Dental Institute

Recruiting

Cleveland, Ohio, United States, 44128

Contacts

Ahmed A Hashem, Profesor

440-502-1591a.hashem@cdiohio.org

Waleed Elmallah, PhD

2163336695w.elmallah@cdiohio.org

Principal Investigator:

Ahmed Hashem, Prof.

More Information

Sponsor

Cleveland Dental Institute

Last update posted

Jul 31, 2024

Last verified

Jul, 2024

Keywords

  • Acute pulpits
  • Electroencephalography
  • Numerical rate scale
  • Inferior Alveolar Nerve Block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cleveland Dental Institute on 2024-07-31.