Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT03877705
Status:
UNKNOWN
Last Update Posted:
2019-03-18
First Post:
2019-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D003773', 'term': 'Dental Plaque'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003741', 'term': 'Dental Deposits'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-01', 'size': 902669, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-03-13T11:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The operator will be blinded to material and assessors will be blinded to the material assignment.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Geriatric bedridden patients'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 98}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2021-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-14', 'studyFirstSubmitDate': '2019-03-12', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Salivary pH', 'timeFrame': '15 days', 'description': 'Degree of acidity or alkalinity of salivary pH'}], 'primaryOutcomes': [{'measure': 'Salivary bacterial count', 'timeFrame': '15 days', 'description': 'Streptococcus mutans count in saliva'}], 'secondaryOutcomes': [{'measure': 'Interdental plaque Bacterial count', 'timeFrame': '15 days', 'description': 'Mesial and distal Interdental plaquns streptococcus mutans count'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental Plaque , salivary pH'], 'conditions': ['Saliva Altered', 'Plaque']}, 'referencesModule': {'availIpds': [{'id': 'Pubmed', 'url': 'http://www.ncbi.nlm.nih.gov/m/pubmed/30455769/?i=6&from=xylitol%20review', 'type': 'Individual Participant Data Set'}], 'references': [{'pmid': '30123770', 'type': 'BACKGROUND', 'citation': 'Oza S, Patel K, Bhosale S, Mitra R, Gupta R, Choudhary D. To Determine the Effect of Chewing Gum Containing Xylitol and Sorbitol on Mutans Streptococci and Lactobacilli Count in Saliva, Plaque, and Gingival Health and to Compare the Efficacy of Chewing Gums. J Int Soc Prev Community Dent. 2018 Jul-Aug;8(4):354-360. doi: 10.4103/jispcd.JISPCD_54_18. Epub 2018 Jul 18.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/m/pubmed/30123770/', 'label': 'Free PMC article'}]}, 'descriptionModule': {'briefSummary': 'This study will be conducted to evaluate the effectiveness of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.', 'detailedDescription': 'This study will be conducted to evaluate the value of using dissolving Xylitol chewable tablets versus xylitol chewing gum with bedridden geriatric patients ,as an alternative to tooth brushing and mouth rinsing, in increasing salivary pH and decreasing bacterial count in both saliva and interdental plaque.plaque and salivary sampling will be taken in certain time ,at baseline T0, then after 5minutes T1, then at 15 days T3. Salivary pH will be measured by using pH meter and streptococcus mutans bacterial count will be calculated through culture in mitis salivarius bacitracin'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age range above 65 years old\n2. Bedridden patients\n3. Males or females\n4. Concious patients\n5. Co-operative patients approving to participate in the trial.\n6. Subjects who signed informed consent\n\nExclusion Criteria:\n\n1. Individuals had taken antibiotics during the last four weeks or anticipated doing so during the study\n2. Subjects who wore removable prosthesis\n3. Patients with systemic diseases that have any oral manifestations\n4. History of Smoking\n5. Allergy to any of chewing gum or tablets ingredients\n6. Evidence of tempromandibular joint disorders\n7. Presence of intraoral infections\n8. Currently using any mouth rinse'}, 'identificationModule': {'nctId': 'NCT03877705', 'briefTitle': 'Xylitol Chewable Tablets Versus Xylitol Chewing Gum in Geriatric Bedridden Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effect of Dissolving Xylitol Chewable Tablets Versus Xylitol Chewing Gum on Salivary pH and Bacterial Count in Geriatric Bedridden Patients : Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Xylitol tabs vs xylitol gum'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dissolving xylitol chewable tablets', 'description': 'Listerine ready tabs 3 times/day', 'interventionNames': ['Drug: Listerine ready tabs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xylitol chewing gum', 'description': 'Trident original 3 times/day', 'interventionNames': ['Drug: Listerine ready tabs']}], 'interventions': [{'name': 'Listerine ready tabs', 'type': 'DRUG', 'otherNames': ['Listerine chewable tablets'], 'description': "Technically, it's a rectangular-shaped, bilayer-compressed tablet that once chewed, creates just enough liquid to swish around your mouth to get a whole-mouth clean feeling.As manufacture claimed the tablet is easy to use just in three simple steps: chew (to activate), swish (to clean), then swallow as unlike mouthwashes which may contain alcohol and other ingredients not intended for ingestion, Listerine Ready Tabs are alcohol-free and safe to swallow which is highly suitable for bedridden patients.", 'armGroupLabels': ['Dissolving xylitol chewable tablets', 'Xylitol chewing gum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '+02', 'city': 'Al Manyal', 'state': 'Giza Governorate', 'country': 'Egypt', 'contacts': [{'name': 'Faculty Of Dentistry, Faculty', 'role': 'CONTACT', 'email': 'dentmail@dentistry.cu.edu.eg', 'phone': '+20223634965'}, {'name': 'Department Of Conservative dentistry, Department', 'role': 'CONTACT', 'email': 'operative@dentistry.cu.edu.eg', 'phone': '+0201068685923'}], 'facility': 'Faculty of dentistry', 'geoPoint': {'lat': 30.02161, 'lon': 31.22563}}], 'centralContacts': [{'name': 'Manar MA Abd elmageed, Resident', 'role': 'CONTACT', 'email': 'dentalmena90@gmail.com', 'phone': '+021287766120'}, {'name': 'Department Of Conservative dentistry, Department', 'role': 'CONTACT', 'email': 'operative@dentistry.cu.edu.eg', 'phone': '+0201068685923'}], 'overallOfficials': [{'name': 'Faculty Of Dentistry, Faculty', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'A paper of the research will be published internationally after results calculation'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Manar abd El mageed ahmed', 'investigatorFullName': 'Manar abd elmageed ahmed', 'investigatorAffiliation': 'Cairo University'}}}}