NCT06510244

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

July 22, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

July 15, 2024

Last Update Submit

July 19, 2024

Conditions

PainElectroencephalographyToothache

Keywords

pain perceptionNumeric Pain Rating Scaleelectroencephalography

Outcome Measures

Primary Outcomes (2)

  • Pain Perception Measurement by EEG.

    to observe the brain waves changes during pain perception

    January 2024-December 2024

  • Pain Perception Measurement by EEG and NRS.

    To establish a possible correlation between the NRS and EEG measurements.

    January 2024-December 2024

Study Arms (1)

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

Interventions

EEG EMOTIVDEVICE

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.

Also known as: Noninvasive Electroencephalography, Endo-Ice
One group of patients between 20-60 years old

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Dental Institute

Cleveland, Ohio, 44128, United States

RECRUITING

Related Publications (7)

  • Alcock MM. Defining pain: past, present, and future. Pain. 2017 Apr;158(4):761-762. doi: 10.1097/j.pain.0000000000000828. No abstract available.

    PMID: 28301403BACKGROUND

  • Matsuda S, Itoi H, Ryoke T, Yoshimura H. How should clinicians assess acute dental pain?: A review. Medicine (Baltimore). 2022 Nov 11;101(45):e31727. doi: 10.1097/MD.0000000000031727.

    PMID: 36397373BACKGROUND

  • Mouraux A, Iannetti GD. The search for pain biomarkers in the human brain. Brain. 2018 Dec 1;141(12):3290-3307. doi: 10.1093/brain/awy281.

    PMID: 30462175BACKGROUND

  • Mussigmann T, Bardel B, Lefaucheur JP. Resting-state electroencephalography (EEG) biomarkers of chronic neuropathic pain. A systematic review. Neuroimage. 2022 Sep;258:119351. doi: 10.1016/j.neuroimage.2022.119351. Epub 2022 Jun 2.

    PMID: 35659993BACKGROUND

  • Ploner M, Sorg C, Gross J. Brain Rhythms of Pain. Trends Cogn Sci. 2017 Feb;21(2):100-110. doi: 10.1016/j.tics.2016.12.001. Epub 2016 Dec 23.

    PMID: 28025007BACKGROUND

  • May ES, Nickel MM, Ta Dinh S, Tiemann L, Heitmann H, Voth I, Tolle TR, Gross J, Ploner M. Prefrontal gamma oscillations reflect ongoing pain intensity in chronic back pain patients. Hum Brain Mapp. 2019 Jan;40(1):293-305. doi: 10.1002/hbm.24373. Epub 2018 Sep 10.

    PMID: 30260531BACKGROUND

  • Holsheimer J, Feenstra BW. Volume conduction and EEG measurements within the brain: a quantitative approach to the influence of electrical spread on the linear relationship of activity measured at different locations. Electroencephalogr Clin Neurophysiol. 1977 Jul;43(1):52-8. doi: 10.1016/0013-4694(77)90194-8.

    PMID: 68872BACKGROUND

MeSH Terms

Conditions

PainToothache

Interventions

Dental Pulp Test

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTooth DiseasesStomatognathic DiseasesFacial Pain

Intervention Hierarchy (Ancestors)

Diagnosis, OralDentistry

Central Study Contacts

Ulises Carballosa, Resident

CONTACT

7866901609u.carballosa@cdiohio.org

Dania Mustafa, Resident

CONTACT

5038510616d.mustafa@cdiohio.org

Study Design

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

Study Record Dates

First Submitted

July 15, 2024

First Posted

July 19, 2024

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

April 1, 2025

Last Updated

July 22, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)