Pain Perception Measurement by EEG and NRS

NCT ID: NCT06510244

Last Updated: 2024-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain Electroencephalography Toothache

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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.

EEG EMOTIV

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Noninvasive Electroencephalography Endo-Ice

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cleveland Dental Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cleveland Dental Institute

Cleveland, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ulises Carballosa, Resident

Role: CONTACT

7866901609

Dania Mustafa, Resident

Role: CONTACT

5038510616

Facility Contacts

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Ulises Carballosa, Resident

Role: primary

786-690-1609

Dania Mustafa, Resident

Role: backup

5038510616

References

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

Reference Type BACKGROUND
PMID: 28301403 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36397373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30462175 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35659993 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28025007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30260531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 68872 (View on PubMed)

Other Identifiers

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CDIENDO0002

Identifier Type: -

Identifier Source: org_study_id

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