Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-09 @ 4:16 AM
Study NCT ID:
NCT03329105
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-30', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Turesky modification of Quigley-Hein plaque index', 'timeFrame': 'Change from Baseline at 1 Month', 'description': 'Evaluation of plaque scores on six representative teeth: 16, 21, 24, 36, 41 \\& 44, using an index that evaluates the plaque revealed on the buccal and lingual non-restored surfaces of the teeth on a scale of 0 to 5, defined by G. A. Quigley and J. W. Hein in 1962 and modified by S. Turesky, N. D. Gilmore, and I. Glickman in 1970.'}, {'measure': 'Presence or absence of gingival bleeding', 'timeFrame': 'Baseline and 1 Month', 'description': 'Presence or absence of gingival bleeding on gentle probing to determine gingival health'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingival Health', 'Biofilm Formation'], 'conditions': ['Chronic Gingivitis', 'Chronic Gingivitis, Plaque Induced']}, 'referencesModule': {'references': [{'pmid': '12102700', 'type': 'BACKGROUND', 'citation': 'Albandar JM, Rams TE. Global epidemiology of periodontal diseases: an overview. Periodontol 2000. 2002;29:7-10. doi: 10.1034/j.1600-0757.2002.290101.x. No abstract available.'}, {'pmid': '16101377', 'type': 'BACKGROUND', 'citation': 'Burt B; Research, Science and Therapy Committee of the American Academy of Periodontology. Position paper: epidemiology of periodontal diseases. J Periodontol. 2005 Aug;76(8):1406-19. doi: 10.1902/jop.2005.76.8.1406. No abstract available.'}, {'pmid': '2061418', 'type': 'BACKGROUND', 'citation': 'Axelsson P, Lindhe J, Nystrom B. On the prevention of caries and periodontal disease. Results of a 15-year longitudinal study in adults. J Clin Periodontol. 1991 Mar;18(3):182-9. doi: 10.1111/j.1600-051x.1991.tb01131.x.'}, {'pmid': '19659714', 'type': 'BACKGROUND', 'citation': 'Bizarra F, Ribeiro S. Improving toothbrushing behaviour in an institution for the disabled in Lisbon, Portugal. Int J Dent Hyg. 2009 Aug;7(3):182-7. doi: 10.1111/j.1601-5037.2009.00387.x.'}, {'pmid': '23738894', 'type': 'BACKGROUND', 'citation': 'Litonjua LA, Cabanilla LL, Abbott LJ. Plaque formation and marginal gingivitis associated with restorative materials. Compend Contin Educ Dent. 2011 May;32(4):e69-72.'}, {'pmid': '9643237', 'type': 'BACKGROUND', 'citation': 'Brecx M. Strategies and agents in supragingival chemical plaque control. Periodontol 2000. 1997 Oct;15:100-8. doi: 10.1111/j.1600-0757.1997.tb00109.x. No abstract available.'}, {'pmid': '9643234', 'type': 'BACKGROUND', 'citation': 'Jackson RJ. Metal salts, essential oils and phenols--old or new? Periodontol 2000. 1997 Oct;15:63-73. doi: 10.1111/j.1600-0757.1997.tb00106.x. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'This study evaluates the addition of a mouth rinse containing sea salt, xylitol and lysozyme to standardized oral health practices on biofilm formation and gingival health in a group of young adults.', 'detailedDescription': 'The purpose of this study is to evaluate a new sea salt mouth rinse containing xylitol and the antibacterial enzyme, lysozyme on biofilm formation and gingival health in a group of young adults. Xylitol is a well-established non-sugar sweetener and an anti-caries agent. The use of this polyol results in loosely adherent biofilms by reducing the amount of extracellular lipopolysaccharides and lipoteichoic acids, facilitating its easy removal by mechanical means. Lysozymes are antibacterial proteins that hydrolyze the linkage between N-acetylmuramic acid and N-acetylglucosamine of peptidoglycan in the cell wall of Gram + bacteria effectively limiting growth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dentate\n* Medically healthy\n* No orthodontic bands\n* An anticipated ability to attend the two scheduled visits\n\nExclusion Criteria:\n\n* Significant medical condition (including but not limited to, poorly controlled diabetes mellitus, rheumatic heart disease or clinically significant heart murmur)\n* Pregnancy\n* Recent history of, or ongoing, antibiotic therapy'}, 'identificationModule': {'nctId': 'NCT03329105', 'briefTitle': 'Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Efficacy of a Rinse Containing Sea Salt and Lysozyme on Biofilm and Gingival Health in a Group of Young Adults: A Pilot Study.', 'orgStudyIdInfo': {'id': '16-272'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sea Salt Mouth Rinse', 'interventionNames': ['Other: Sea Salt Mouth Rinse', 'Other: Standardized Oral Health Practices']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standardized Oral Health Practices', 'interventionNames': ['Other: Standardized Oral Health Practices']}], 'interventions': [{'name': 'Sea Salt Mouth Rinse', 'type': 'OTHER', 'description': 'Rinsing mouth with a tablespoon of sea salt mouth rinse without any dilution, for 30 seconds, once in the morning and once before bed, in addition to Standardized Oral Health Practices.', 'armGroupLabels': ['Sea Salt Mouth Rinse']}, {'name': 'Standardized Oral Health Practices', 'type': 'OTHER', 'description': 'Brushing teeth for two minutes using the modified Bass technique, twice per day with the provided dentifrice, and flossing once daily using the spool method', 'armGroupLabels': ['Sea Salt Mouth Rinse', 'Standardized Oral Health Practices']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 5E4', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'College of Dentistry, University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Jay Hoover', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, College of Dentistry'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jay Hoover', 'investigatorAffiliation': 'University of Saskatchewan'}}}}