Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 3:51 PM
Study NCT ID:
NCT04366869
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2020-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Which is More Effective in Management of Bruxism: Botox or Occlusal Splints
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002012', 'term': 'Bruxism'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D006184', 'term': 'Habits'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003828', 'term': 'Denture, Overlay'}, {'id': 'D017090', 'term': 'Occlusal Splints'}, {'id': 'D019274', 'term': 'Botulinum Toxins, Type A'}], 'ancestors': [{'id': 'D003778', 'term': 'Dentures'}, {'id': 'D017266', 'term': 'Dental Prosthesis'}, {'id': 'D011476', 'term': 'Prosthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D009989', 'term': 'Orthotic Devices'}, {'id': 'D009983', 'term': 'Orthopedic Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D001905', 'term': 'Botulinum Toxins'}, {'id': 'D008666', 'term': 'Metalloendopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045726', 'term': 'Metalloproteases'}, {'id': 'D001426', 'term': 'Bacterial Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D001427', 'term': 'Bacterial Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-15', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patient satisfaction: questionnaire', 'timeFrame': '12months', 'description': 'Patients satisfaction was evaluated using TMD/ NS numeric scales 10 cm questionnaire which included: headache, face pain, face tension, limitation of mouth opening and complaints during mastication with scores from 1 to 10 whereas 1 means least pain and 10 means highest pain.it was assessed at baseline (T0), then after 3months(T3) then after 6months from baseline(T6), then after 9months from baseline(T9) and finally after 12 months from baseline (T12). which means every 3 months.'}], 'secondaryOutcomes': [{'measure': 'Electromyography', 'timeFrame': '12 months', 'description': 'measuring muscle activity for massetter and temporalis muscle at baseline,3,6,9,12 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bruxism']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the efficacy of Botulinum toxin (Botox) and traditional occlusal splints for the management of bruxism in edentulous patients rehabilitated with MIOD', 'detailedDescription': '42 edentulous patients having implant retained mandibular overdenture suffering from bruxism with clinical manifestation, will be randomly divided into three groups, group 1 control group (traditional approach of removing denture at night) ,group 2 will be managed by occlusal splints whereas group 3 will be managed with botulinum toxin injection (Botox). New maxillary dentures and mandibular over dentures will be constructed for both groups. Muscle activity will be measured at time of denture insertion (T0), 3(T3) 6(T6), 9(T9) and 12(T12) month of treatment. Patients satisfaction will be evaluated at the time of denture insertion (T0), 6(T6), and 12(T12) month of treatment using TMD/ NS numeric scales 10 cm questionnaire which include: headache, face pain, face tension, limitation of mouth opening and complaints during mastication.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients diagnosed with bruxism\n* patients had mandibular implant retained overdentures within the previous 3 years\n* cooperative patients\n* physically and psychologically able patients to tolerate the procedure\n\nExclusion Criteria:\n\n* patients taking muscle relaxants\n* patients without neuromuscular control\n* poor oral hygiene'}, 'identificationModule': {'nctId': 'NCT04366869', 'briefTitle': 'Which is More Effective in Management of Bruxism: Botox or Occlusal Splints', 'organization': {'class': 'OTHER', 'fullName': 'October University for Modern Sciences and Arts'}, 'officialTitle': 'Which is More Effective in Management of Bruxism for Implant Overdenture Patients: Botox or Occlusal Splints - A One Year Clinical Study', 'orgStudyIdInfo': {'id': 'OctoberUMSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'traditional approach of removing denture at night', 'interventionNames': ['Device: overdenture']}, {'type': 'EXPERIMENTAL', 'label': 'intervention 1', 'description': 'occlusal splint', 'interventionNames': ['Device: occlusal splint']}, {'type': 'EXPERIMENTAL', 'label': 'intervention 2', 'description': 'Botox', 'interventionNames': ['Drug: Botox']}], 'interventions': [{'name': 'overdenture', 'type': 'DEVICE', 'description': 'removal of overdenture at night', 'armGroupLabels': ['control']}, {'name': 'occlusal splint', 'type': 'DEVICE', 'description': 'occlusal splint on overdenture', 'armGroupLabels': ['intervention 1']}, {'name': 'Botox', 'type': 'DRUG', 'otherNames': ['Bolitinum Toxins'], 'description': 'Botox injection i masseter in temporalis', 'armGroupLabels': ['intervention 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '311', 'city': 'Giza', 'country': 'Egypt', 'facility': 'MSA', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'overallOfficials': [{'name': 'Dina Elawady, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'October University for Modern Sciences and Arts', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Dina ElAwady', 'investigatorAffiliation': 'October University for Modern Sciences and Arts'}}}}