Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-01 @ 9:58 AM
Study NCT ID:
NCT02752594
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2016-04-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consumption of Probiotics on Salivary Bacteria Causing Dental Caries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2016-06-16', 'releaseDate': '2016-05-11'}, {'resetDate': '2016-07-28', 'releaseDate': '2016-06-18'}, {'resetDate': '2017-06-06', 'releaseDate': '2017-04-28'}, {'resetDate': '2017-07-18', 'releaseDate': '2017-07-18'}], 'estimatedResultsFirstSubmitDate': '2016-05-11'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'C562118', 'term': 'exopolysaccharide biopolymer, Bacillus coagulans'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2016-04-18', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'counts of streptococcus mutans after the consumption of probiotic', 'timeFrame': '15 days', 'description': 'Human saliva was assessed for the counts of streptococcus mutans, one of the major etiological factor for dental caries'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['probiotic', 'mutans streptococci', 'bacillus coagulans', 'caries'], 'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'Dental caries is a multifactorial disease effecting majority of the human population.One of the etiological factor causing dental caries is salivary mutans streptococci. Reducing the levels of this bacteria in the saliva can significantly reduce the incidence of dental caries. A non-invasive intervention, such as the administration of probiotics reduced the salivary mutans streptococci levels.', 'detailedDescription': '40 candidates were selected from a pre-determined group and were randomly assigned to two groups. Group A (n=20) was administered probiotic drink and Group B (n=20) was administered placebo for 14 consecutive days. Saliva was collected on day 1 and day 15 to compare the salivary mutans streptococci levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Decayed Missing Filled Surfaces less than or equal to 6\n* Brushes twice daily\n\nExclusion Criteria:\n\n* undergoing orthodontic treatment\n* topical fluoride therapy in the past 2 yrs\n* using sugar free gums'}, 'identificationModule': {'nctId': 'NCT02752594', 'briefTitle': 'Consumption of Probiotics on Salivary Bacteria Causing Dental Caries', 'organization': {'class': 'OTHER', 'fullName': 'Sharda University'}, 'officialTitle': 'Evaluation of the Consumption of Probiotics on the Bacteria Causing Dental Caries: A Randomised Clinical Trial', 'orgStudyIdInfo': {'id': 'D22052015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'probiotic', 'description': '2 mg of probiotic powder mixed in 10 ml of distilled water', 'interventionNames': ['Biological: probiotic', 'Other: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '10 ml of distilled water', 'interventionNames': ['Biological: probiotic', 'Other: placebo']}], 'interventions': [{'name': 'probiotic', 'type': 'BIOLOGICAL', 'otherNames': ['bacillus coagulans'], 'description': 'Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention', 'armGroupLabels': ['placebo', 'probiotic']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'placebo was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention', 'armGroupLabels': ['placebo', 'probiotic']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'G. RATNA VELUGU, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sharda University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sharda University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'G.RATNA VELUGU', 'investigatorAffiliation': 'Sharda University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2016-05-11', 'type': 'RELEASE'}, {'date': '2016-06-16', 'type': 'RESET'}, {'date': '2016-06-18', 'type': 'RELEASE'}, {'date': '2016-07-28', 'type': 'RESET'}, {'date': '2017-04-28', 'type': 'RELEASE'}, {'date': '2017-06-06', 'type': 'RESET'}, {'date': '2017-07-18', 'type': 'RELEASE'}, {'date': '2017-07-18', 'type': 'RESET'}], 'unpostedResponsibleParty': 'G.RATNA VELUGU, Assistant Professor, Sharda University'}}}}