Pain Perception Measurement by EEG and NRS

July 19, 2024 updated by: Cleveland Dental Institute

Measuring Pain Perception to the Same Stimulus in Different Patients Using Electroencephalography and Numerical Rate Scale

Observational study at CDI Cleveland Dental Institute. Investigators will assess the pain perception in one group of patients using two non-invasive methods. First, a numerical rate scale (NRS) and second, a brain wave EEG.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

To generate the nociceptive stimulus, The investigators will apply cold (Endo-Ice) to a healthy upper incisor tooth #8. Inclusion criteria: Patients between 20 and 60 years old, with healthy teeth, no history of dental alveolar trauma, and no pulp chamber calcification. After the nociceptive stimulus, patients will write their pain perception on paper from 0 to 10, and at the same time, we will record the brain activity with a non-invasive EEG Emotiv. Then, we will correlate both methods.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44128
        • Recruiting
        • Cleveland Dental Institute
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Ulises Carballosa, Resident
        • Sub-Investigator:
          • Dania Mustafa, Resident
        • Principal Investigator:
          • Ahmed Hashem, Dentist
        • Principal Investigator:
          • Waleed Elmallah, Dentist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

In the outpatient clinic of CDI Cleveland Dental Institute, patients with mature and vital tooth #8 are between 20 and 60 years old.

Description

Inclusion Criteria:

  • Males and females
  • Age: 20-60 years.
  • Tooth #8 vital and mature. No history of dentoalveolar trauma.
  • Adequate coronal tooth structure.

Exclusion Criteria:

  • Chronic periodontitis.
  • Vertical root fracture.
  • Immature teeth.
  • Necrotic teeth.
  • Systemic diseases that affect the healing process.
  • Non restorable teeth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
One group of patients between 20-60 years old
Patients between 20-60 years old with a tooth health and no history of dental alveolar trauma or pulp chamber calcification.
Device: EEG EMOTIV
The teeth will be dried with 2x2 gauze; then, Endo Ice will be applied. The patient response will be written on a sheet numbering to choose from 0 to 10, and at the same time, the brain waves will be recorded through EEG.
Other Names:
  • Noninvasive Electroencephalography
  • Endo-Ice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Perception Measurement by EEG.
Time Frame: January 2024-December 2024
to observe the brain waves changes during pain perception
January 2024-December 2024
Pain Perception Measurement by EEG and NRS.
Time Frame: January 2024-December 2024
To establish a possible correlation between the NRS and EEG measurements.
January 2024-December 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Dental Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

July 15, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 19, 2024

Study Record Updates

Last Update Posted (Actual)

July 22, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDIENDO0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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