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RecruitingNCT06526572Updated Jul 31, 2024

Pain Measured by NRS and EEG in Acute Pulpitis

An observational study in Acute Pulpitis, sponsored by Cleveland Dental Institute. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by Cleveland Dental Institute · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Pulpitis

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Keywords

  • Acute pulpits
  • Electroencephalography
  • Numerical rate scale
  • Inferior Alveolar Nerve Block
03

In context

Pulpitis

316 studies on the registry are indexed under Pulpitis; 90 are open to participants now.

This study's planned enrollment of 50 is below the median of 75 across 23 observational studies indexed under Pulpitis.

Browse Pulpitis studies →

Lead sponsor

Cleveland Dental Institute is the lead sponsor of 6 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 to participate in the study. Able to communicate effectively in the language used for study procedures.

Exclusion criteria

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 for dental procedures or EEG recordings as determined by the study's dental and medical professionals.

Inability to understand and follow study instructions.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testBrain wave analysis using electroencephalography (EEG).

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

  • Diagnostic testNumerical rate Scale (NRS)

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

06

What researchers measure

Primary outcomes

  1. Electroencephalography (EEG)

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

    Time frame: 3 months

  2. 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.

    Time frame: 3 months

07

Study locations

1 of 1 sites recruiting
  • Cleveland Dental Institute
    Cleveland, Ohio 44128, United States
    Recruiting
    • Ahmed A Hashem, Profesor · Contacta.hashem@cdiohio.org · 440-502-1591
    • Waleed Elmallah, PhD · Contactw.elmallah@cdiohio.org · 2163336695
    • Ahmed Basyoni, resident · Sub investigator
    • Abdelrahman Zaghloul, resident · Sub investigator
    • Ahmed Hashem, Prof. · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06526572
Lead sponsor
Cleveland Dental Institute
Responsible party
Sponsor
First posted
Jul 30, 2024
Start date
Jul 1, 2023
Primary completion
Oct 31, 2024 (estimated)
Completion
Jan 31, 2025 (estimated)
Last update
Jul 31, 2024

Study contacts

Ahmed I Basyoni
Contact
a.basyoni@cdiohio.org
3612290038
Abdelrahman Zaghloul
Contact
a.zaghloul@cdiohio.org
9016324289
Ahmed A hashem, PhD
study director · CDI

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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