Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-04-08 @ 10:54 PM
Study NCT ID:
NCT02102295
Status:
COMPLETED
Last Update Posted:
2014-04-02
First Post:
2014-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antioxidant Dentifrice on Gingivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-03', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-03-29', 'studyFirstSubmitDate': '2014-03-23', 'studyFirstSubmitQcDate': '2014-03-29', 'lastUpdatePostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'salivary antioxidant status', 'timeFrame': '3 months', 'description': 'Salivary antioxidant status was assessed by the ferric reduction ability of plasma (FRAP).'}], 'primaryOutcomes': [{'measure': 'Gingival Index', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Gingivitis Severity Inedex', 'timeFrame': '3 months'}, {'measure': 'Gingival Redness', 'timeFrame': '3 months', 'description': 'Gingival redness was measured as an indicator of the degree of local chromatic changes in the gingiva.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gingivitis', 'antioxidant', 'dentifrice', 'Ascorbic Acid Derivative', 'L ascorbic acid 2 phosphate magnesium salt'], 'conditions': ['Gingivitis']}, 'referencesModule': {'references': [{'pmid': '25277459', 'type': 'DERIVED', 'citation': 'Shimabukuro Y, Nakayama Y, Ogata Y, Tamazawa K, Shimauchi H, Nishida T, Ito K, Chikazawa T, Kataoka S, Murakami S. Effects of an ascorbic acid-derivative dentifrice in patients with gingivitis: a double-masked, randomized, controlled clinical trial. J Periodontol. 2015 Jan;86(1):27-35. doi: 10.1902/jop.2014.140138.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of a dentifrice containing L-ascorbic acid 2-phosphate magnesium salt on gingival inflammation, gingival bleeding and gingival redness.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between ≥ 20 and \\< 65 y with at least 16 permanent teeth.\n* Gingival inflammation or mean baseline GI ≥ 0.5 without severe periodontal disease enough to require professional therapy.\n* Written informed consent to participate.\n\nExclusion Criteria:\n\n* Taking medications that could influence periodontal tissue health, such as antimicrobials and antihypertensives within 1 month before starting the trial.\n* Use of orthodontic appliances.\n* Pregnancy or planning to become pregnant during the trial period.\n* Previous participation in any other clinical trial.\n* Inability of patient to understand the study purpose and/or study protocols.\n* Judged unsuitable by investigators for other reasons.'}, 'identificationModule': {'nctId': 'NCT02102295', 'briefTitle': 'Effects of Antioxidant Dentifrice on Gingivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lion Corporation'}, 'officialTitle': 'Clinical Study of an Ascorbic Acid Derivative Dentifrice in Patients With Gingivitis', 'orgStudyIdInfo': {'id': 'LionSDP-6'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Experimental toothpaste', 'description': 'L-ascorbic acid 2-phosphate magnesium salt / fluoride', 'interventionNames': ['Drug: Experimental toothpaste']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control toothpaste', 'description': 'fluoride', 'interventionNames': ['Drug: Control toothpaste']}], 'interventions': [{'name': 'Experimental toothpaste', 'type': 'DRUG', 'otherNames': ['L-ascorbic acid 2-phosphate magnesium salt toothpaste'], 'description': 'Experimental toothpaste was containing 0.3% L-ascorbic acid 2-phosphate magnesium salt and 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.', 'armGroupLabels': ['Experimental toothpaste']}, {'name': 'Control toothpaste', 'type': 'DRUG', 'otherNames': ['Fluoride toothpaste'], 'description': 'Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.', 'armGroupLabels': ['Control toothpaste']}]}, 'contactsLocationsModule': {'locations': [{'zip': '271-8587', 'city': 'Matsudo', 'state': 'Chiba', 'country': 'Japan', 'facility': 'Nihon University Hospital, School of Dentistry at Matsudo', 'geoPoint': {'lat': 35.77995, 'lon': 139.90144}}, {'zip': '980-8575', 'city': 'Sendai', 'state': 'Miyagi', 'country': 'Japan', 'facility': 'Tohoku University Dental Hospital', 'geoPoint': {'lat': 38.26667, 'lon': 140.86667}}, {'zip': '565-0871', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Osaka University Dental Hospital', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}, {'zip': '101-8310', 'city': 'Chiyoda-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Nihon University Dental Hospital'}], 'overallOfficials': [{'name': 'Shinya Murakami', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Osaka University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lion Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Osaka University', 'class': 'OTHER'}, {'name': 'Tohoku University', 'class': 'OTHER'}, {'name': 'Nihon University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}