Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT05176158
Status:
COMPLETED
Last Update Posted:
2024-12-04
First Post:
2021-12-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dexketoprofen Dosage According to Chronotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014095', 'term': 'Tooth, Impacted'}, {'id': 'D014313', 'term': 'Trismus'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C118296', 'term': 'dexketoprofen trometamol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-30', 'studyFirstSubmitDate': '2021-12-14', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Trismus', 'timeFrame': 'Baseline and post operatory (day 1, day 3 and day 7)', 'description': 'Open mouth limitation in milimiters, interincisal distance'}, {'measure': 'Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha', 'timeFrame': 'Baseline, day 3 and day 7', 'description': 'Blood sample analysis for inflammatory cytokines in IU/ml by ELISA test (enzyme-linked immunoassay)'}], 'primaryOutcomes': [{'measure': 'Post operatory pain', 'timeFrame': 'From the day of the surgical procedure to the seventh-day', 'description': 'Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain))'}], 'secondaryOutcomes': [{'measure': 'Swelling', 'timeFrame': 'Baseline and post operatory (day 1, day 3, day 7)', 'description': 'Distance from tragus to pogonion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Third', 'Dexketroprofen', 'Randomized'], 'conditions': ['Tooth, Impacted', 'Trismus', 'Pain', 'Inflammatory Response']}, 'descriptionModule': {'briefSummary': 'Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration.\n\nThe aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (dexketoprofen) affects on postoperative pain, swelling and open mouth limitation according the circadian clock', 'detailedDescription': 'A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed randomly in one side intake morning medication dosage while the contralateral side will be prescribed a night dosage. Moreover, a blood sample will be obtained to analyze the inflammatory profile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bilateral impacted lower third molar\n\nExclusion Criteria:\n\n* NSAID allergic\n* Contraindication of surgery'}, 'identificationModule': {'nctId': 'NCT05176158', 'briefTitle': 'Dexketoprofen Dosage According to Chronotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Complutense de Madrid'}, 'officialTitle': 'Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms', 'orgStudyIdInfo': {'id': '2019-000736-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morning dosage', 'description': 'Dexketoprofen pill at morning; Placebo at night', 'interventionNames': ['Drug: Dexketoprofen 25 MG']}, {'type': 'EXPERIMENTAL', 'label': 'Night dosage', 'description': 'Placebo pill at morning; Dexketoprofen at night', 'interventionNames': ['Drug: Dexketoprofen 25 MG']}], 'interventions': [{'name': 'Dexketoprofen 25 MG', 'type': 'DRUG', 'otherNames': ['Morning dosage'], 'description': 'Pill at morning', 'armGroupLabels': ['Morning dosage']}, {'name': 'Dexketoprofen 25 MG', 'type': 'DRUG', 'otherNames': ['Night dosage'], 'description': 'Pill at night', 'armGroupLabels': ['Night dosage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28040', 'city': 'Madrid', 'country': 'Spain', 'facility': 'UCM', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Complutense de Madrid', 'class': 'OTHER'}, 'collaborators': [{'name': 'McGill University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jesús Torres García Denche', 'investigatorAffiliation': 'Universidad Complutense de Madrid'}}}}