Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT01622920
Status:
COMPLETED
Last Update Posted:
2013-03-19
First Post:
2012-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-03-15', 'studyFirstSubmitDate': '2012-06-14', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2013-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enamel thickness reproducibility measurements', 'timeFrame': '2 weeks', 'description': 'To know if ultrasound can reliably and reproducibly measure enamel thickness in-vivo'}], 'secondaryOutcomes': [{'measure': 'Enamel thickness reproducibility measurements on separate occasions', 'timeFrame': '2 weeks (concurrent with primary outcome)', 'description': 'To investigate whether ultrasound can be used to reproducibly measure enamel thickness on human incisor teeth in vivo on three separate occasions'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['enamel erosion', 'ultrasound', 'reproducibility', 'human central incisor', 'reliability'], 'conditions': ['Tooth Erosion']}, 'descriptionModule': {'briefSummary': 'The investigators have now established a technique to measure enamel thickness which has been shown to work well in-vitro. The teeth tested so far, obtained from the Dental School Tissue Bank, have been molars or pre-molars. In these cases, the measurement is made more difficult by the curvature of the tooth surface and it seems likely that flatter larger, incisors would give more satisfactory results. The investigators therefore wish to establish in-vivo whether this hypothesis is correct.', 'detailedDescription': "The aim is translate our research into a clinical hand-held dental tool that could be used to measure enamel thickness in less curvaceous anterior incisor (front) teeth, and ultimately monitor erosive tooth surface loss (TSL), which mainly occurs on anterior (front) teeth and the occlusal (top) surface of posterior (back) teeth. In this study, quantifying enamel thickness with ultrasound will provide data which will be assessed for reproducibility and to determine whether or not ultrasound is a potentially viable tool to measure and monitor acid erosion of teeth. This would allow dentists to reinforce advice to patients to reduce acidic consumption, and will motivate them to keep whatever is remaining of their 'precious' enamel tissue, which if lost, will necessitate fillings to be made. These fillings will require future repairs and possible remakes, as they have median survival rates of five years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy adults over 18 years (females and males) with normal salivary flow.\n2. Volunteers with absence of dental caries and/or periodontal disease on the maxillary incisors (upper front teeth) to be used in the study.\n3. Volunteers should have sound maxillary incisors with no obvious cracks in the crown.\n4. Volunteers who willingly signed an informed consent.\n5. Volunteers who are willing to follow the research schedule for the period of the study.\n\nExclusion Criteria:\n\n1. Volunteers with abnormal enamel on maxillary incisors assessed by visual inspection.\n2. Volunteers with replaced enamel on maxillary incisors (eg fillings, crowns, bridges).\n3. Volunteers who appear to have hypoplastic teeth as part of a syndrome, e.g. osteogenesis imperfect.\n4. Volunteers having orthodontic appliances on front teeth, or presence of fixed or removable dentures (replacing missing front teeth).\n5. Volunteers who have a complex dental history such as periodontitis, dentine sensitivity or salivary dysfunction.\n6. Volunteers who have any condition could be expected to interfere with the volunteer's safety during the study.\n7. Volunteers who demonstrate an inability to comply with study procedures.\n8. Signed informed consent not obtained by the volunteer."}, 'identificationModule': {'nctId': 'NCT01622920', 'acronym': 'UMET', 'briefTitle': 'Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness', 'organization': {'class': 'OTHER', 'fullName': 'University of Leeds'}, 'officialTitle': 'Preliminary Clinical Study of Ultrasound to Measure Enamel Thickness', 'orgStudyIdInfo': {'id': 'UMET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'ultrasound enamel thickness measurements', 'description': 'Enamel thickness will be measured with ultrasound', 'interventionNames': ['Other: Ultrasound transducer']}], 'interventions': [{'name': 'Ultrasound transducer', 'type': 'OTHER', 'description': 'A hand-held ultrasound transducer will be placed on a central incisor and enamel thickness measurements recorded', 'armGroupLabels': ['ultrasound enamel thickness measurements']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LU', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'University of Leeds, Leeds Dental Institute (DenTCRU)', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Khalid Sindi, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Leeds (Leeds Dental Instiitute)'}, {'name': 'Lynn Gutteridge, BDS, MDS, FDS RCS, MRD RCS', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Leeds (Leeds Dental Institute)'}, {'name': 'Nigel Bubb, Bsc, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Leeds (Leeds Dental Institute)'}, {'name': 'Anthony Evans, BSc, MSc, PhD, CSci', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Leeds (Department of Medical Physics, Leeds Institute of Genetics, Health and Therapeutics)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leeds', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Mr', 'investigatorFullName': 'Khalid Sindi', 'investigatorAffiliation': 'University of Leeds'}}}}