Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT04208802
Status:
COMPLETED
Last Update Posted:
2024-02-14
First Post:
2019-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Smoking on Saliva Composition and the Development of Dental Erosion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014077', 'term': 'Tooth Erosion'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D057085', 'term': 'Tooth Wear'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples are obtained and retained for 10 years.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-12', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-19', 'lastUpdatePostDateStruct': {'date': '2024-02-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcium release from bovine enamel and dentin specimens by extraoral erosion (nmol/Square Millimeter).', 'timeFrame': 'Immediately after the intraoral device has been worn once for two hours.'}], 'secondaryOutcomes': [{'measure': 'Determination of unstimulated and stimulated saliva flow rate (mL/min).', 'timeFrame': 'Saliva samples are collected for 5 min each on three visits.'}, {'measure': 'Determination of saliva pH (pH).', 'timeFrame': 'Saliva samples are collected for 5 min each on three visits.'}, {'measure': 'Determination of salivary buffer capacity (pH).', 'timeFrame': 'Saliva samples are collected for 5 min each on three visits.'}, {'measure': 'Determination of total protein content (mg/L) and protein composition (qualitatively) in saliva.', 'timeFrame': 'Saliva samples are collected for 5 min each on three visits.'}, {'measure': 'Determination of inorganic calcium (mmol/L), phosphate (mmol/L) and fluoride (µmol/L) in saliva.', 'timeFrame': 'Saliva samples are collected for 5 min each on three visits.'}, {'measure': 'Determination of total protein concentration (ng/Square Millimeter) and protein composition (qualitatively) within the salivary pellicles.', 'timeFrame': 'Immediately after the intraoral device with resin samples has been worn once for two hours.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Erosion']}, 'referencesModule': {'references': [{'pmid': '24603346', 'type': 'BACKGROUND', 'citation': 'Carpenter G, Cotroneo E, Moazzez R, Rojas-Serrano M, Donaldson N, Austin R, Zaidel L, Bartlett D, Proctor G. Composition of enamel pellicle from dental erosion patients. Caries Res. 2014;48(5):361-7. doi: 10.1159/000356973. Epub 2014 Mar 6.'}, {'pmid': '24993266', 'type': 'BACKGROUND', 'citation': 'Moazzez R, Bartlett D. Intrinsic causes of erosion. Monogr Oral Sci. 2014;25:180-96. doi: 10.1159/000360369. Epub 2014 Jun 26.'}, {'pmid': '18607835', 'type': 'BACKGROUND', 'citation': 'Wiegand A, Bliggenstorfer S, Magalhaes AC, Sener B, Attin T. Impact of the in situ formed salivary pellicle on enamel and dentine erosion induced by different acids. Acta Odontol Scand. 2008 Aug;66(4):225-30. doi: 10.1080/00016350802183401.'}, {'pmid': '18523383', 'type': 'BACKGROUND', 'citation': 'Wiegand A, Meier W, Sutter E, Magalhaes AC, Becker K, Roos M, Attin T. Protective effect of different tetrafluorides on erosion of pellicle-free and pellicle-covered enamel and dentine. Caries Res. 2008;42(4):247-54. doi: 10.1159/000135669. Epub 2008 Jun 4.'}, {'pmid': '23774653', 'type': 'BACKGROUND', 'citation': 'Zwier N, Huysmans MC, Jager DH, Ruben J, Bronkhorst EM, Truin GJ. Saliva parameters and erosive wear in adolescents. Caries Res. 2013;47(6):548-52. doi: 10.1159/000350361. Epub 2013 Jun 15.'}, {'pmid': '27022647', 'type': 'BACKGROUND', 'citation': 'Kanzow P, Wegehaupt FJ, Attin T, Wiegand A. Etiology and pathogenesis of dental erosion. Quintessence Int. 2016 Apr;47(4):275-8. doi: 10.3290/j.qi.a35625.'}, {'pmid': '31163440', 'type': 'BACKGROUND', 'citation': 'Wiegand A, Rosemann A, Hoch M, Barke S, Dakna M, Kanzow P. Erosion-Protective Capacity of the Salivary Pellicle of Female and Male Subjects Is Not Different. Caries Res. 2019;53(6):636-642. doi: 10.1159/000500046. Epub 2019 Jun 4.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether smoking is associated with changes in salivary composition and/or predisposition to erosion.\n\nHealthy volunteers are observationally wearing an intraoral device with both bovine tooth specimens (enamel and dentin) and resin specimens twice for two hours each. Afterwards, specimens are eroded extraorally and calcium release into the acid is measured.\n\nTotal protein concentration and protein composition of the salivary pellicles on the resin samples are measured. Additionally, salivary parameters (unstimulated and stimulated saliva flow rate, pH, buffer capacity, total protein content and protein composition as well as concentration of inorganic calcium, phosphate, and fluoride) are measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Exploratory study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Volunteers aged between 20 and 50 years who are able to give written consent\n\nExclusion Criteria:\n\n* Non-fulfillment of the inclusion criteria\n* Intake of medications or diseases altering salivary secretion\n* Refusal to use fluoridated toothpastes\n* Known allergies to substances used in the study\n* Orthodontic treatment or malfunction which does not allow wearing an intraoral device'}, 'identificationModule': {'nctId': 'NCT04208802', 'briefTitle': 'Effect of Smoking on Saliva Composition and the Development of Dental Erosion', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': 'Effect of Smoking on Saliva Composition and the Development of Dental Erosion - an In-situ Study', 'orgStudyIdInfo': {'id': 'Erosion-Smoking'}, 'secondaryIdInfos': [{'id': '15/10/19', 'type': 'OTHER', 'domain': 'Local Ethics Commission'}, {'id': '02785', 'type': 'OTHER', 'domain': 'UMG study center'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Smokers', 'description': 'Volunteers smoking at least 10 cigarettes per day', 'interventionNames': ['Other: Use of fluoridated toothpaste', 'Other: Wearing of an intraoral device with bovine tooth samples', 'Other: Wearing of an intraoral device with resin samples']}, {'label': 'Non-smokers', 'description': 'Non-smoking volunteers', 'interventionNames': ['Other: Use of fluoridated toothpaste', 'Other: Wearing of an intraoral device with bovine tooth samples', 'Other: Wearing of an intraoral device with resin samples']}], 'interventions': [{'name': 'Use of fluoridated toothpaste', 'type': 'OTHER', 'description': 'Use of fluoridated toothpaste', 'armGroupLabels': ['Non-smokers', 'Smokers']}, {'name': 'Wearing of an intraoral device with bovine tooth samples', 'type': 'OTHER', 'description': 'Wearing of an intraoral device with bovine tooth samples', 'armGroupLabels': ['Non-smokers', 'Smokers']}, {'name': 'Wearing of an intraoral device with resin samples', 'type': 'OTHER', 'description': 'Wearing of an intraoral device with resin samples', 'armGroupLabels': ['Non-smokers', 'Smokers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'state': 'Lower Saxony', 'country': 'Germany', 'facility': 'University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}], 'overallOfficials': [{'name': 'Annette Wiegand, Prof. Dr. med. dent.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Dental Practitioner', 'investigatorFullName': 'Philipp Kanzow, PD Dr. med. dent., Dr. rer. medic.', 'investigatorAffiliation': 'University Medical Center Goettingen'}}}}