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RecruitingNCT06510244Updated Jul 22, 2024

Pain Perception Measurement by EEG and NRS

An observational study in Pain, Electroencephalography and Toothache, sponsored by Cleveland Dental Institute. Recruiting at 1 site in United States. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-07-22.

Primary conditionToothacheRegistry: PainReclassifiedWhy we changed it
Registry
Pain — the first condition term the registry derived for this study.
ClinicalTrials.gg
Toothache
Why
  1. The study's listed conditions name Toothache, a narrower term within Pain.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Cleveland Dental Institute · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 10 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
100
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pain
  • Electroencephalography
  • Toothache

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Keywords

  • pain perception
  • Numeric Pain Rating Scale
  • electroencephalography
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In context

Toothache Reclassified

142 studies on the registry are indexed under Toothache; 28 are open to participants now.

This study's planned enrollment of 100 is close to the median of 100 across 15 observational studies indexed under Toothache.

Browse Toothache studies →

Lead sponsor

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

Compared within Toothache, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →

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Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
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.

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

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

Exclusion criteria

Exclusion Criteria:

  • Chronic periodontitis.
  • Vertical root fracture.
  • Immature teeth.
  • Necrotic teeth.
  • Systemic diseases that affect the healing process.
  • Non restorable teeth.
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • DeviceEEG 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.

    Also known as: Noninvasive Electroencephalography, Endo-Ice

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What researchers measure

Primary outcomes

  1. Pain Perception Measurement by EEG.

    to observe the brain waves changes during pain perception

    Time frame: January 2024-December 2024

  2. Pain Perception Measurement by EEG and NRS.

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

    Time frame: January 2024-December 2024

07

Study locations

1 of 1 sites recruiting
  • Cleveland Dental Institute
    Cleveland, Ohio 44128, United States
    Recruiting
    • Ulises Carballosa, Resident · Contactu.carballosa@cdiohio.org · 786-690-1609
    • Dania Mustafa, Resident · Contactd.mustafa@cdiohio.org · 5038510616
    • Ulises Carballosa, Resident · Sub investigator
    • Dania Mustafa, Resident · Sub investigator
    • Ahmed Hashem, Dentist · Principal investigator
    • Waleed Elmallah, Dentist · Principal investigator
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References and documents

Publications

  • Alcock MM. Defining pain: past, present, and future. Pain. 2017 Apr;158(4):761-762. doi: 10.1097/j.pain.0000000000000828. No abstract available. PubMed 28301403 ↗
  • 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. PubMed 36397373 ↗
  • 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. PubMed 30462175 ↗
  • 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. PubMed 35659993 ↗
  • 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. PubMed 28025007 ↗
  • 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. PubMed 30260531 ↗
  • 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. PubMed 68872 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Dec 2024, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 15, 2024
First posted
Jul 19, 2024
StartActual
Jan 1, 2024
Primary completionEst.
Dec 2024
CompletionEst.
Apr 2025
Last update
Jul 22, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06510244
Lead sponsor
Cleveland Dental Institute
Responsible party
Sponsor
First posted
Jul 19, 2024
Start date
Jan 1, 2024
Primary completion
Dec 2024 (estimated)
Completion
Apr 2025 (estimated)
Last update
Jul 22, 2024

Study contacts

Ulises Carballosa, Resident
Contact
u.carballosa@cdiohio.org
7866901609
Dania Mustafa, Resident
Contact
d.mustafa@cdiohio.org
5038510616

Oversight

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

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