Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2026-01-12 @ 2:43 AM
Study NCT ID:
NCT01712802
Status:
COMPLETED
Last Update Posted:
2017-03-29
First Post:
2012-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Study of Denture Adhesive
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009066', 'term': 'Mouth, Edentulous'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C102654', 'term': 'Polident'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-27', 'studyFirstSubmitDate': '2012-10-17', 'studyFirstSubmitQcDate': '2012-10-23', 'lastUpdatePostDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'General satisfaction Patient reported outcomes', 'timeFrame': 'day 3 of adhesives application', 'description': 'General satisfaction (100mm visual analogue scale)'}], 'secondaryOutcomes': [{'measure': 'Moisture Objective outcomes', 'timeFrame': 'day 3 of each adhesives application', 'description': 'moisture(%)'}, {'measure': 'masticatory function', 'timeFrame': 'day 3 of each adhesives application', 'description': 'Color change of chewing gum measured by color sensing machine (color scale: categorical)'}, {'measure': 'retentive force', 'timeFrame': 'day 3 of each adhesives application', 'description': 'The maximum occlusal force that can bite before denture moves(N)'}, {'measure': 'Oral related quality of life', 'timeFrame': 'day 3 of adhesives application', 'description': 'Oral health impact profile (OHIP) edentulous Japanese version'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Edentulous']}, 'referencesModule': {'references': [{'pmid': '30975019', 'type': 'DERIVED', 'citation': 'Ohwada G, Minakuchi S, Sato Y, Kondo H, Nomura T, Tsuboi A, Hong G, Itoh Y, Kawai Y, Kimoto S, Gunji A, Suzuki A, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Subjective Evaluation of Denture Adhesives: A Multicenter Randomized Controlled Trial. JDR Clin Trans Res. 2020 Jan;5(1):50-61. doi: 10.1177/2380084419837607. Epub 2019 Apr 11.'}, {'pmid': '27756441', 'type': 'DERIVED', 'citation': 'Kimoto S, Kawai Y, Gunji A, Kondo H, Nomura T, Murakami T, Tsuboi A, Hong G, Minakuchi S, Sato Y, Ohwada G, Suzuki T, Kimoto K, Hoshi N, Saita M, Yoneyama Y, Sato Y, Morokuma M, Okazaki J, Maeda T, Nakai K, Ichikawa T, Nagao K, Fujimoto K, Murata H, Kurogi T, Yoshida K, Nishimura M, Nishi Y, Murakami M, Hosoi T, Hamada T. Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial. Trials. 2016 Oct 18;17(1):506. doi: 10.1186/s13063-016-1612-x.'}]}, 'descriptionModule': {'briefSummary': 'To establish evidence based guidelines for denture adhesives (powder and cream), multicenter cross over randomized clinical trial will be carried out.\n\nThe null hypotheses are that there are no difference on improvement from baseline to post application of two adhesives powder and cream, in terms of general satisfaction, oral related quality of life, masticatory function and oral conditions.', 'detailedDescription': 'This is multicenter study of 10 academic affiliated institutions. The clinical trial will be carried out in randomized allocation at each site, and data will be gathered. The intervention will be 3-arms and center institution (Nihon University) will generate each site random numbers for allocation and each site will follow this randomization. Research protocol had been published at Nihon University and distributed to each site.To survey its protocol compliance, the study meeting will be held periodically (twice an year).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* edentulous\n\nExclusion Criteria:\n\n* Cannot answer the questionnaire\n* Deteriorating general conditions\n* Maxillofacial defect\n* Metal denture user\n* Already denture adhesive users\n* Severe xerostomia'}, 'identificationModule': {'nctId': 'NCT01712802', 'acronym': 'DAG', 'briefTitle': 'Multicenter Study of Denture Adhesive', 'organization': {'class': 'OTHER', 'fullName': 'Nihon University'}, 'officialTitle': 'Multicenter Randomized Clinical Study of Denture Adhesive to Establish the Guideline', 'orgStudyIdInfo': {'id': 'KAKEN-24390439'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Denture Adhesives: Cream', 'description': 'Parallel arm that receives application of Cream denture adhesives.', 'interventionNames': ['Other: Denture Adhesives: Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Denture Adhesives: Powder', 'description': 'Parallel arm that receives application of powder denture adhesive.', 'interventionNames': ['Other: Denture Adhesives: Powder']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'Parallel arm that receive placebo.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Denture Adhesives: Cream', 'type': 'OTHER', 'otherNames': ['Polident'], 'description': 'Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.', 'armGroupLabels': ['Denture Adhesives: Cream']}, {'name': 'Denture Adhesives: Powder', 'type': 'OTHER', 'otherNames': ['Poligrip powder'], 'description': 'Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.', 'armGroupLabels': ['Denture Adhesives: Powder']}, {'name': 'Saline', 'type': 'OTHER', 'otherNames': ['Otsuka normal saline'], 'description': 'work as control for Denture Adhesives: Cream and Powder', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2718587', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Nihon University', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}], 'overallOfficials': [{'name': 'Yasuhiko Kawai, DDS MSc PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Nihon University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nihon University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Iwate Medical University', 'class': 'OTHER'}, {'name': 'Tohoku University', 'class': 'OTHER'}, {'name': 'Tsurumi University', 'class': 'OTHER'}, {'name': 'Kanagawa Dental University Junior College', 'class': 'OTHER'}, {'name': 'Tokyo Medical and Dental University', 'class': 'OTHER'}, {'name': 'Osaka Dental University', 'class': 'UNKNOWN'}, {'name': 'Hiroshima University', 'class': 'OTHER'}, {'name': 'University of Tokushima', 'class': 'OTHER'}, {'name': 'Nagasaki University', 'class': 'OTHER'}, {'name': 'Kagoshima University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yasuhiko Kawai', 'investigatorAffiliation': 'Nihon University'}}}}