Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:23 AM
Study NCT ID:
NCT07445633
Status:
COMPLETED
Last Update Posted:
2026-03-03
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Ability of Brain Waves Activity to Detect Patient Susceptibility to Post-Operative Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003788', 'term': 'Dental Pulp Diseases'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-22', 'size': 556872, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2026-02-25T10:18', 'hasProtocol': True}, {'date': '2021-12-22', 'size': 82591, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2026-02-25T10:17', 'hasProtocol': False}, {'date': '2021-12-22', 'size': 63598, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-13T16:23', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2025-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'brain wave activity', 'timeFrame': '24 hours', 'description': 'The primary outcome is the correlation between pre-operative brain wave activity and post-operative pain intensity'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pulp Disease, Dental']}, 'referencesModule': {'references': [{'pmid': '15009162', 'type': 'BACKGROUND', 'citation': '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': '32591813', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of patients seeking dental treatment at the Department of Endodontics, Faculty of Dentistry, Ain Shams University.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Patient's age ranges from 20-40.\n2. Vital lower first molar with signs and symptoms of acute irreversible pulpitis and indicated for single visit root canal treatment.\n3. Patients that had not received any medicinal therapy after endodontic treatment.\n4. Patients who are mentally and physically capable to record pain intensity estimated every 6 hours after endodontic treatment using VAS.\n\nExclusion criteria:\n\n1. Patient systemic disease or neurogenic disease that contraindicates the use of the EEG or have sensitivity to the electrode material.\n2. Cases that root canal treatment could not be finished in a single visit such as teeth with apical periodontitis, pulpal necrosis, chronic apical abscess.\n3. Patients who took analgesics within 24 hours after endodontic treatment."}, 'identificationModule': {'nctId': 'NCT07445633', 'briefTitle': 'The Ability of Brain Waves Activity to Detect Patient Susceptibility to Post-Operative Pain', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Ability of Brain Waves Activity to Detect Patient Susceptibility to Post-Operative Pain', 'orgStudyIdInfo': {'id': 'FDASU-Rec IM122127'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with low alpha frequency preoperatively ranging from 8 to 10.', 'interventionNames': ['Diagnostic Test: Detection of th alpha brain waves activity']}, {'label': 'patients with high alpha frequency ranging from 11 to 13.', 'interventionNames': ['Diagnostic Test: Detection of th alpha brain waves activity']}], 'interventions': [{'name': 'Detection of th alpha brain waves activity', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['patients with high alpha frequency ranging from 11 to 13.', 'patients with low alpha frequency preoperatively ranging from 8 to 10.']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}