The Ability of Brain Waves Activity to Detect Patient Susceptibility to Post-Operative Pain

NCT07445633 | Completed FDA Device

• 1 other identifier: FDASU-Rec IM122127
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study evaluates whether resting-state EEG alpha activity can help identify endodontic patients at higher risk of post-operative pain following single-visit root canal treatment. EEG will be recorded before treatment and pain intensity will be self-reported using a Visual Analogue Scale (VAS) during the early post-treatment period.

Conditions

Pulp Disease, Dental

Outcome Measures

Primary Outcomes (1)

• brain wave activity

  The primary outcome is the correlation between pre-operative brain wave activity and post-operative pain intensity

  24 hours

Study Arms (2)

patients with low alpha frequency preoperatively ranging from 8 to 10.

Diagnostic Test: Detection of th alpha brain waves activity

patients with high alpha frequency ranging from 11 to 13.

Diagnostic Test: Detection of th alpha brain waves activity

Interventions

Detection of th alpha brain waves activity DIAGNOSTIC_TEST

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.

patients with high alpha frequency ranging from 11 to 13.; patients with low alpha frequency preoperatively ranging from 8 to 10.

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population consists of patients seeking dental treatment at the Department of Endodontics, Faculty of Dentistry, Ain Shams University.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

Related Publications (2)

• 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.

  PMID: 15009162 BACKGROUND

• 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.

  PMID: 32591813 BACKGROUND

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: March 3, 2026
• Study Start: January 1, 2022
• Primary Completion: March 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)