Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2025-12-28 @ 11:49 PM
Study NCT ID:
NCT01566357
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2012-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Milk on Erosion/Abrasion of Enamel and Dentin - an in Situ Study
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014100', 'term': 'Toothpastes'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'C447032', 'term': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}], 'ancestors': [{'id': 'D003802', 'term': 'Dentifrices'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-17', 'studyFirstSubmitDate': '2012-03-27', 'studyFirstSubmitQcDate': '2012-03-28', 'lastUpdatePostDateStruct': {'date': '2013-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance loss (profilometry)', 'timeFrame': 'after each study phase (5 days)', 'description': 'Each intervention will be tested for 5 days in situ. Then, enamel or dentin loss, respectively, will be determined by profilometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dental erosion', 'enamel', 'dentin'], 'conditions': ['Erosion Protection']}, 'referencesModule': {'references': [{'pmid': '18578180', 'type': 'BACKGROUND', 'citation': 'Wiegand A, Muller I, Schnapp JD, Werner C, Attin T. Impact of fluoride, milk and water rinsing on surface rehardening of acid softened enamel. An in situ study. Am J Dent. 2008 Apr;21(2):113-8.'}, {'pmid': '20980757', 'type': 'BACKGROUND', 'citation': 'Hemingway CA, White AJ, Shellis RP, Addy M, Parker DM, Barbour ME. Enamel erosion in dietary acids: inhibition by food proteins in vitro. Caries Res. 2010;44(6):525-30. doi: 10.1159/000320984. Epub 2010 Oct 28.'}, {'pmid': '21160185', 'type': 'BACKGROUND', 'citation': 'White AJ, Gracia LH, Barbour ME. Inhibition of dental erosion by casein and casein-derived proteins. Caries Res. 2011;45(1):13-20. doi: 10.1159/000322300. Epub 2010 Dec 11.'}, {'pmid': '20083245', 'type': 'BACKGROUND', 'citation': 'Wiegand A, Hiestand B, Sener B, Magalhaes AC, Roos M, Attin T. Effect of TiF4, ZrF4, HfF4 and AmF on erosion and erosion/abrasion of enamel and dentin in situ. Arch Oral Biol. 2010 Mar;55(3):223-8. doi: 10.1016/j.archoralbio.2009.11.007. Epub 2010 Jan 18.'}, {'pmid': '25038509', 'type': 'DERIVED', 'citation': 'Wiegand A, Attin T. Randomised in situ trial on the effect of milk and CPP-ACP on dental erosion. J Dent. 2014 Sep;42(9):1210-5. doi: 10.1016/j.jdent.2014.07.009. Epub 2014 Jul 17.'}]}, 'descriptionModule': {'briefSummary': 'This in situ study aims to investigate\n\n* the protective potential of milk and fluoridated milk on erosive wear of enamel\n* the protective potential of milk and fluoridated milk on erosive wear of dentin\n* to compare to protective potential of milk and fluoridated milk with products containing casein phosphopeptide-amorphous calcium phosphate\n* to compare the protective potential of milk and fluoridated milk with a fluoridated toothpaste or stannous-chloride containing fluoride solution (SnCl2/AmF/NaF)', 'detailedDescription': 'Dental erosion is defined as the pathogenic, chronic, chemical removal of dental hard tissues due to the frequent contact to extrinsic or intrinsic acids. The dissolution process is determined by the pH, the chelating properties, mineral content and kind of acid, but in the same time modified by various biological (e.g. saliva, pellicle) and behavioural factors.\n\nThe anticariogenic properties of milk are widely investigated, but information of the effects of milk or milk components on the development of erosion are limited. It is suggested that the demineralisation process is reduced by the presence of calcium and phosphate, but also that casein proteins affect the demineralisation by adsorbing to the hydroxyapatite surface and inhibiting its dissolution. Initial studies suggest that milk is able to increase rehardening of acid-softened enamel, but information about the effects of milk on dentin erosion are not available yet. Particularly, the effect of fluoridated milk on dental erosion was not investigated yet.\n\nIn contrast, recent studies analysed the effects of products containing casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) on erosion, as it is suggested that CPP-ACP promotes a supersaturated state and increased remineralisation of demineralised dental hard tissue. However, in situ studies on the effect of CPP-ACP on erosion are limited to one study, which compared microhardness of enamel after treatment with CPP-ACP and CPP-ACP and 900 ppm fluoride, but failed to use appropriate controls in form of other products containing calcium and phosphate or fluoride. In summary, the effects of milk, in particular fluoridated milk, and products containing milk proteins, such as casein phosphopeptide-amorphous calcium phosphate, on erosive wear were not analysed in an in-situ-model so far.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n* non-treated caries lesions\n* orthodontic treatment which does not allow to wear an intraoral device\n* hyposalivation\n* allergy against milk or milk proteins'}, 'identificationModule': {'nctId': 'NCT01566357', 'briefTitle': 'Impact of Milk on Erosion/Abrasion of Enamel and Dentin - an in Situ Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Impact of Milk and Casein Phosphopeptide-amorphous Calcium Phosphate on Erosion/Abrasion of Enamel and Dentin - an in Situ Study', 'orgStudyIdInfo': {'id': '029/UZS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Fluoride-free toothpaste'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoride toothpaste', 'interventionNames': ['Other: Toothpaste']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Milk', 'interventionNames': ['Dietary Supplement: Milk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoridated milk', 'interventionNames': ['Dietary Supplement: Fluoridated Milk']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CPP-ACP', 'interventionNames': ['Drug: Tooth Mousse']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoridated CPP-ACP', 'interventionNames': ['Drug: MI Paste Plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoride mouthrinse', 'interventionNames': ['Drug: Elmex Erosion Protection']}], 'interventions': [{'name': 'Toothpaste', 'type': 'OTHER', 'armGroupLabels': ['Fluoride toothpaste']}, {'name': 'Milk', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Milk']}, {'name': 'Fluoridated Milk', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Fluoridated milk']}, {'name': 'Tooth Mousse', 'type': 'DRUG', 'armGroupLabels': ['CPP-ACP']}, {'name': 'MI Paste Plus', 'type': 'DRUG', 'armGroupLabels': ['Fluoridated CPP-ACP']}, {'name': 'Elmex Erosion Protection', 'type': 'DRUG', 'armGroupLabels': ['Fluoride mouthrinse']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'Clinic for Preventive Dentistry, Periodontology and Cariology, University of Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Annette Wiegand, PD Dr. med. dent.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Zurich, Switzerland'}, {'name': 'Thomas Attin, Prof. Dr. med. dent.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Zurich, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Borrow Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med. dent.', 'investigatorFullName': 'Annette Wiegand, PD Dr. med. dent.', 'investigatorAffiliation': 'University of Zurich'}}}}