Pulp Disease, DentalNCT07445633
The Ability of Brain Waves Activity to Detect Patient Susceptibility to Post-Operative Pain
An observational study of Pulp Disease, Dental, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Pulp Disease, Dental
- What is being tested?
- Detection of th alpha brain waves activity
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study population consists of patients seeking dental treatment at the Department of Endodontics, Faculty of Dentistry, Ain Shams University.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pulp Disease, Dental
- Being tested
- Detection of th alpha brain waves activity
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of th alpha brain waves activityDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with low alpha frequency preoperatively ranging from 8 to 10. | Not described Receives: Diagnostic Test: Detection of th alpha brain waves activity | |
| patients with high alpha frequency ranging from 11 to 13. | Not described Receives: Diagnostic Test: Detection of th alpha brain waves activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
brain wave activity
The primary outcome is the correlation between pre-operative brain wave activity and post-operative pain intensity
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start1 Jan 2022
- Primary completion1 Mar 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulp Disease, DentalStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445633
- Sponsor's protocol ID
- FDASU-Rec IM122127
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 15009162Furman 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.
PubMed 32591813
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Brain Waves Activity to Detect Patient Susceptibility to Post-Operative Pain
- ClinicalTrials.gov ID
- NCT07445633
- Acronym / sponsor ID
- FDASU-Rec IM122127
- Conditions
- Pulp Disease, Dental
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of patients seeking dental treatment at the Department of Endodontics, Faculty of Dentistry, Ain Shams University.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Detection of th alpha brain waves activityThe 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. | Diagnostic test | patients with high alpha frequency ranging from 11 to 13., patients with low alpha frequency preoperatively ranging from 8 to 10. |
Primary outcome
brain wave activity
Time frame: 24 hours
The primary outcome is the correlation between pre-operative brain wave activity and post-operative pain intensity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 15009162Cruccu 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.
- Background: PubMed 32591813Furman 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulp Disease, Dental, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
brain wave activity (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445633, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.