Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-28 @ 2:18 PM
Study NCT ID:
NCT01293968
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2011-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013281', 'term': 'Stomatitis, Aphthous'}], 'ancestors': [{'id': 'D013280', 'term': 'Stomatitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}, {'id': 'D004155', 'term': 'Diphenhydramine'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001559', 'term': 'Benzhydryl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ka.mojabi@yahoo.com', 'phone': '09127841440', 'title': 'Dr.Katayun Borhanmojabi', 'organization': 'Qazvin University of Medical Sciences'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Small number of population. Studying just one concentration of Ibuprofen. Lack of a placebo.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Ibuprofen, Diphenhydramine and Aluminium MgS', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Diphenhydramine and Aluminium MgS', 'otherNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ibuprofen, Diphenhydramine and Aluminium MgS', 'description': 'the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days'}, {'id': 'OG001', 'title': 'Diphenhydramine and Aluminium MgS', 'description': 'the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days'}], 'classes': [{'categories': [{'measurements': [{'value': '3.176', 'groupId': 'OG000', 'lowerLimit': '1.169', 'upperLimit': '5.183'}, {'value': '3.821', 'groupId': 'OG001', 'lowerLimit': '2.028', 'upperLimit': '5.614'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'four days after the start of the study', 'description': 'pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution', 'unitOfMeasure': 'scores in Visual Analogue Scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS'}, {'type': 'SECONDARY', 'title': 'The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation', 'timeFrame': '4 days after the solution consumption', 'description': 'pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed', 'unitOfMeasure': 'scales in Visual Analogue Scale', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ibuprofen, Diphenhydramine and Aluminium MgS'}, {'id': 'FG001', 'title': 'Diphenhydramine and Aluminium MgS'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'non-cooperation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Ibuprofen, Diphenhydramine and Aluminium MgS'}, {'id': 'BG001', 'title': 'Diphenhydramine and Aluminium MgS'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '32.4', 'spread': '10.04', 'groupId': 'BG000'}, {'value': '32.0', 'spread': '10.0', 'groupId': 'BG001'}, {'value': '32.2', 'spread': '10.02', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Iran, Islamic Republic of', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-05', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-05-16', 'studyFirstSubmitDate': '2011-02-10', 'resultsFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2011-02-10', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-05-16', 'studyFirstPostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation', 'timeFrame': 'four days after the start of the study', 'description': 'pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution'}], 'secondaryOutcomes': [{'measure': 'The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation', 'timeFrame': '4 days after the solution consumption', 'description': 'pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aphthous Stomatitis', 'Ibuprofen', 'treatment efficacy'], 'conditions': ['Aphthous Stomatitis']}, 'descriptionModule': {'briefSummary': 'The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)', 'detailedDescription': 'Recurrent aphthous stomatitis (RAS) is the most painful oral lesion with a considerable prevalence . The most common aphthous ulcer treatments include applying topical agents such as antibiotics, Non Steroidal Anti Inflammatory Drugs (NSAIDs) to immunosuppressants.\n\nThe mixture of Diphenhydramine and Aluminum MgS suspension has been prescribed as an analgesic mouthwash for a long time in order to decrease a great number of oral ulcers symptoms such as aphthous ulcers. Ibuprofen is a potent NSAID with fair anti-inflammatory potential prescribed in dental pains.\n\nThis double-blind randomized clinical trial was conducted to assess the effect of Ibuprofen, Diphenhydramine and Aluminium MgS mixture on symptoms of aphthous ulcers.40 patients will be participating in this study,20 will receive the mixture of Diphenhydramine and Aluminium MgS while the other group will receive Ibuprofen, Diphenhydramine and Aluminium MgS mixture.\n\nAll patients will be instructed to apply the drug on the site of the ulcer 30-60 minutes before meals, 3 times daily. The ulcers will be assessed when the drug is applied for 3 days and the level of pain and irritation will be estimated by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* possessing at least one painful aphthous ulcer in the last 3 days\n* older than 10 years of age\n\nExclusion Criteria:\n\n* systemic disease or specific syndrome (such as Behcet's)\n* pregnancy\n* breastfeeding\n* allergy to NSAIDs\n* history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders\n* consumption of anti-inflammatory medications in the last 24 hours"}, 'identificationModule': {'nctId': 'NCT01293968', 'briefTitle': 'Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis', 'organization': {'class': 'OTHER', 'fullName': 'Qazvin University Of Medical Sciences'}, 'officialTitle': 'Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis', 'orgStudyIdInfo': {'id': 'qums353'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg', 'interventionNames': ['Drug: Ibuprofen, Diphenhydramine and Aluminium MgS']}, {'type': 'ACTIVE_COMPARATOR', 'label': '100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg', 'interventionNames': ['Drug: Diphenhydramine and Aluminium MgS']}], 'interventions': [{'name': 'Ibuprofen, Diphenhydramine and Aluminium MgS', 'type': 'DRUG', 'description': '3 times daily for 3 days', 'armGroupLabels': ['5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg']}, {'name': 'Diphenhydramine and Aluminium MgS', 'type': 'DRUG', 'description': '3 times daily for 3 days', 'armGroupLabels': ['100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qazvin', 'state': 'Qazvin Province', 'country': 'Iran', 'facility': 'Dental faculty of Qazvin University of Medical Sciences', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}, {'city': 'Qazvin', 'state': 'Qazvin Province', 'country': 'Iran', 'facility': 'Qazvin University of Medical sciences', 'geoPoint': {'lat': 36.26877, 'lon': 50.0041}}], 'overallOfficials': [{'name': 'Katayun Borhanmojabi, D.D.S,M.S', 'role': 'STUDY_CHAIR', 'affiliation': 'QUMS'}, {'name': 'Katayun Borhanmojabi, D.D.S,M.S', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QUMS'}, {'name': 'Marjan Nasiri asl, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QUMS'}, {'name': 'Faeze Mirmiran, D.D.S', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QUMS'}, {'name': 'Pantea Nazeman, student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'QUMS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qazvin University Of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Miss', 'investigatorFullName': 'Pantea Nazeman', 'investigatorAffiliation': 'Qazvin University Of Medical Sciences'}}}}