Ignite Creation Date:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2026-01-26 @ 8:14 AM
Study NCT ID:
NCT02597192
Status:
COMPLETED
Last Update Posted:
2015-11-05
First Post:
2015-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Effects of Bacillus Containing Oral Hygiene Products on Gingivitis: a Randomized Controlled Trial
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C488892', 'term': 'PIP protein, human'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2015-10-30', 'studyFirstSubmitQcDate': '2015-11-03', 'lastUpdatePostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'gingival index scores', 'timeFrame': '8weeks'}], 'secondaryOutcomes': [{'measure': 'plaque index scores', 'timeFrame': '8weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['gingivitis', 'gingival inflammation', 'probiotics', 'Bacillus'], 'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'Aim: Evaluating the clinical effects of a Bacillus subtilis, Bacillus megaterium and Bacillus pumulus containing toothpaste, mouthwash and toothbrush cleaner versus a placebo in patients with generalized gingivitis.\n\nMaterials and methods: In this double-blind placebo-controlled randomized clinical trial generalized gingivitis patients who were systemically healthy and who did not smoke were included. They used a placebo or probiotic Bacillus containing toothbrush cleaner for 8 weeks. Primary outcome measures of interest were plaque and gingivitis index, secondary outcome measures were pocket probing depth and bleeding on probing.', 'detailedDescription': 'The administration of micro-organisms to improve the human health was already promoted by the Nobel prizewinning scientist Eli Metchnikoff in the beginning of the 20th century. However, it took several decades for this subject to become a topic of interest in medicine. At this moment these micro-organisms are called "probiotics" and defined as "living microorganisms which, when administered in adequate amounts, confer a health benefit for the host" (http://www.who.int/foodsafety/publications/fs\\_management/en/probiotics.pdf). Over the past decade probiotics have been extensively investigated from the perspective of oral health. It was shown that probiotics have the capacity to reduce mutans streptococci counts in saliva and/or plaque during their usage, that they have a positive influence on bad breath and that they can improve the results of scaling and root planing in periodontitis patients. A positive effect of probiotic usage on plaque accumulation and gingivitis measurements in gingivitis patients was also shown.To the investigators knowledge, at this moment no trials are available describing the effect of other probiotic genera on gingivitis. Since it is clear that probiotic effects are strain, dosage and mode of application dependent, the aim of this study was to evaluate the use of a probiotic toothpaste, mouthwash and toothbrush cleaner with Bacillus subtilis, Bacillus megaterium, and Bacillus pumulus versus a placebo in patients with generalized gingivitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with plaque-induced gingivitis\n* a pocket probing depth not more than 5 mm\n* at least 20 natural teeth\n* no history of periodontal therapy or previous use of antibiotics or anti-inflammatory medication within the preceding 6 months\n\nExclusion Criteria:\n\n* patients with hematologic disorders, or other systemic illness\n* pregnant and lactating females\n* patients undergoing orthodontic treatment\n* those with smoking habits were excluded.'}, 'identificationModule': {'nctId': 'NCT02597192', 'briefTitle': 'Clinical Effects of Bacillus Containing Oral Hygiene Products on Gingivitis: a Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Cukurova University'}, 'officialTitle': 'Professor Doctor, Cukurova University Faculty of Dentistry', 'orgStudyIdInfo': {'id': 'CukurovaU-7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active test group', 'description': 'probiotic oral hygiene products with Bacillus (PIP, Chrisal)', 'interventionNames': ['Other: probiotic oral hygiene products with Bacillus (PIP, Chrisal)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'oral hygiene products without Bacillus', 'interventionNames': ['Other: oral hygiene products without Bacillus']}], 'interventions': [{'name': 'probiotic oral hygiene products with Bacillus (PIP, Chrisal)', 'type': 'OTHER', 'description': 'products with Bacillus probiotics', 'armGroupLabels': ['Active test group']}, {'name': 'oral hygiene products without Bacillus', 'type': 'OTHER', 'description': 'products without Bacillus', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01330', 'city': 'Adana', 'country': 'Turkey (Türkiye)', 'facility': 'Cukurova University', 'geoPoint': {'lat': 36.98615, 'lon': 35.32531}}], 'overallOfficials': [{'name': 'Onur Ozcelik, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cukurova University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cukurova University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Onur Ozcelik', 'investigatorAffiliation': 'Cukurova University'}}}}