NCT06526572

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 30, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

July 18, 2024

Last Update Submit

July 29, 2024

Conditions

Acute Pulpitis

Keywords

Acute pulpitsElectroencephalographyNumerical rate scaleInferior Alveolar Nerve Block

Outcome Measures

Primary Outcomes (2)

  • Electroencephalography (EEG)

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

    3 months

  • Numerical Rate Scale (NRS)

    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

Study Arms (1)

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).Diagnostic Test: Numerical rate Scale (NRS)

Interventions

Brain wave analysis using electroencephalography (EEG).DIAGNOSTIC_TEST

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

symptomatic acute pulpitis
Numerical rate Scale (NRS)DIAGNOSTIC_TEST

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

symptomatic acute pulpitis

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Dental Institute

Cleveland, Ohio, 44128, United States

RECRUITING

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Ahmed A hashem, PhD

    CDI Centro Diagnostico Italiano S.p.A

    STUDY DIRECTOR

Central Study Contacts

Ahmed I Basyoni

CONTACT

3612290038a.basyoni@cdiohio.org

Abdelrahman Zaghloul

CONTACT

9016324289a.zaghloul@cdiohio.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 30, 2024

Study Start

July 1, 2023

Primary Completion

October 31, 2024

Study Completion

January 31, 2025

Last Updated

July 31, 2024

Record last verified: 2024-07

Locations

US(1)