- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445633
The Ability of Brain Waves Activity to Detect Patient Susceptibility to Post-Operative Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This observational clinical study is designed to examine the association between resting-state electroencephalography (EEG) alpha activity and the intensity of post-operative pain following single-visit root canal treatment. Participants will be recruited from an endodontic clinic after ethics committee approval. Resting-state EEG will be recorded using a wearable EEG system prior to treatment. Post-operative pain intensity will be assessed using a patient-reported Visual Analogue Scale (VAS) during the early post-treatment period.
Participants will be classified based on baseline alpha activity (e.g., lower versus higher alpha power range). Analyses will evaluate whether baseline EEG alpha measures are associated with subsequent pain ratings and whether differences in alpha activity relate to higher post-operative pain susceptibility. The goal is to determine whether EEG alpha activity may serve as a practical biomarker for post-endodontic pain susceptibility.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Cairo, Egypt
- Ain Shams University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Patient's age ranges from 20-40.
- Vital lower first molar with signs and symptoms of acute irreversible pulpitis and indicated for single visit root canal treatment.
- Patients that had not received any medicinal therapy after endodontic treatment.
- Patients who are mentally and physically capable to record pain intensity estimated every 6 hours after endodontic treatment using VAS.
Exclusion criteria:
- Patient systemic disease or neurogenic disease that contraindicates the use of the EEG or have sensitivity to the electrode material.
- Cases that root canal treatment could not be finished in a single visit such as teeth with apical periodontitis, pulpal necrosis, chronic apical abscess.
- Patients who took analgesics within 24 hours after endodontic treatment.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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patients with low alpha frequency preoperatively ranging from 8 to 10.
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The study utilizes the EMOTIV® EPOC X, a mobile, wireless 14-channel EEG headset.
This differs from traditional clinical EEG setups that often require bulky, wired equipment and the application of messy conductive gels, making this method much more suitable for a chair-side dental environment.
|
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patients with high alpha frequency ranging from 11 to 13.
|
The study utilizes the EMOTIV® EPOC X, a mobile, wireless 14-channel EEG headset.
This differs from traditional clinical EEG setups that often require bulky, wired equipment and the application of messy conductive gels, making this method much more suitable for a chair-side dental environment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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brain wave activity
Time Frame: 24 hours
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The primary outcome is the correlation between pre-operative brain wave activity and post-operative pain intensity
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24 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Cruccu G, Anand P, Attal N, Garcia-Larrea L, Haanpaa M, Jorum E, Serra J, Jensen TS. EFNS guidelines on neuropathic pain assessment. Eur J Neurol. 2004 Mar;11(3):153-62. doi: 10.1111/j.1468-1331.2004.00791.x.
- Furman AJ, Prokhorenko M, Keaser ML, Zhang J, Chen S, Mazaheri A, Seminowicz DA. Sensorimotor Peak Alpha Frequency Is a Reliable Biomarker of Prolonged Pain Sensitivity. Cereb Cortex. 2020 Nov 3;30(12):6069-6082. doi: 10.1093/cercor/bhaa124.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDASU-Rec IM122127
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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