Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-07 @ 2:56 AM
Study NCT ID:
NCT02449434
Status:
COMPLETED
Last Update Posted:
2021-10-05
First Post:
2015-05-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057085', 'term': 'Tooth Wear'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'david.bartlett@kcl.ac.uk', 'phone': '02071887462', 'title': 'Prof David Bartlett', 'organization': "King's College London"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed', 'description': 'Non applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Severe Erosive Tooth Wear', 'description': 'BEWE score of 12 or higher and at least one score of 3 in a sextant\n\nNon applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Mild/Moderate Erosive Tooth Wear', 'description': 'BEWE score of 10 or lower and no score of 3 on any surface of any tooth\n\nNon applicable -- All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Basic Erosive Wear Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}, {'value': '300', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Severe Erosive Tooth Wear', 'description': 'Erosive tooth wear cases were defined as those with a BEWE score of 12 or higher and at least one score of 3 in a sextant'}, {'id': 'OG001', 'title': 'Mild/Moderate Erosive Tooth Wear', 'description': 'Controls were defined as those with a BEWE score of 10 or lower and no score of 3 on any surface of any tooth (clinically classified as no or mild erosive tooth wear)'}], 'classes': [{'categories': [{'measurements': [{'value': '15.01', 'spread': '2.3', 'groupId': 'OG000'}, {'value': '6.27', 'spread': '2.79', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.25', 'pValueComment': 'Only results from fully adjusted regression models will be deemed as significant', 'groupDescription': 'A minimum sample size of 490 participants (245 in each group) was needed. This calculation assumed the proportion of adults with high dietary acid intake (3+ times/day) was 55% among cases and 40% among controls (expected odds ratio of 2.25), case- control ratio of 1-to-1, 90% statistical power and 95% significance level.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Unconditional binary logistic regression and reported using odds ratios and 95% confidence intervals', 'nonInferiorityComment': 'Using the presence or absence of severe erosive wear as the dependent variable, the unadjusted, sex-and-age- adjusted and fully adjusted associations of the included variables with erosive tooth wear were estimated using unconditional binary logistic regression and reported using odds ratios (OR).'}], 'paramType': 'MEAN', 'timeFrame': 'Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes', 'description': 'Each tooth will be graded by the extent of the surface which the acid has damaged. The Basic Erosive Wear Examination (BEWE) index will grade tooth wear on the buccal, occlusal and palatal/lingual surfaces of each tooth excluding third molars. This ordinal scale graded tooth wear from 0 to 3 (0 = no wear, 1 = early surface loss, 2 = surface loss \\< 50% or specific defect, 3 = surface loss \\> 50%). The worst score in each sextant will be taken to be the sextant score. A cumulative score will be calculated for the mouth by adding each sextant score, which can range from 0-18. A higher score indicates a higher level of erosive tooth wear (worse outcome)', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Severe Erosive Tooth Wear', 'description': 'a BEWE score of 12 or higher and at least one score of 3 in a sextant'}, {'id': 'FG001', 'title': 'Mild/Moderate Erosive Tooth Wear', 'description': 'A BEWE score of 10 or lower and no score of 3 on any surface of any tooth'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '300'}, {'groupId': 'FG001', 'numSubjects': '300'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': "Participants (n = 600) aged 18 years or older, were recruited between May 2014 and March 2016 following referral by their general dental practitioners (GDP) for erosive tooth wear (cases, n = 300) or general treatment (controls, n = 300) to the restorative clinics at King's College London Dental Institute."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Severe Erosive Tooth Wear', 'description': 'BEWE score of 12 or higher and at least one score of 3 in a sextant whereas'}, {'id': 'BG001', 'title': 'Mild/Moderate Erosive Tooth Wear', 'description': 'BEWE score of 10 or lower and no score of 3 on any surface of any tooth'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '285', 'groupId': 'BG000'}, {'value': '285', 'groupId': 'BG001'}, {'value': '570', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '138', 'groupId': 'BG000'}, {'value': '175', 'groupId': 'BG001'}, {'value': '313', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '162', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '287', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '300', 'groupId': 'BG000'}, {'value': '300', 'groupId': 'BG001'}, {'value': '600', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-12-03', 'size': 97914, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-09-04T06:52', 'hasProtocol': True}, {'date': '2013-12-01', 'size': 191859, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-09-04T06:55', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-14', 'studyFirstSubmitDate': '2015-05-18', 'resultsFirstSubmitDate': '2020-01-09', 'studyFirstSubmitQcDate': '2015-05-18', 'lastUpdatePostDateStruct': {'date': '2021-10-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-07', 'studyFirstPostDateStruct': {'date': '2015-05-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Basic Erosive Wear Examination', 'timeFrame': 'Single reading of wear of the teeth at the appointment date. Examination of wear takes 5 minutes', 'description': 'Each tooth will be graded by the extent of the surface which the acid has damaged. The Basic Erosive Wear Examination (BEWE) index will grade tooth wear on the buccal, occlusal and palatal/lingual surfaces of each tooth excluding third molars. This ordinal scale graded tooth wear from 0 to 3 (0 = no wear, 1 = early surface loss, 2 = surface loss \\< 50% or specific defect, 3 = surface loss \\> 50%). The worst score in each sextant will be taken to be the sextant score. A cumulative score will be calculated for the mouth by adding each sextant score, which can range from 0-18. A higher score indicates a higher level of erosive tooth wear (worse outcome)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Tooth Wear']}, 'referencesModule': {'references': [{'pmid': '27856311', 'type': 'RESULT', 'citation': "O'Toole S, Bernabe E, Moazzez R, Bartlett D. Timing of dietary acid intake and erosive tooth wear: A case-control study. J Dent. 2017 Jan;56:99-104. doi: 10.1016/j.jdent.2016.11.005. Epub 2016 Nov 14."}]}, 'descriptionModule': {'briefSummary': 'This is a questionnaire based study investigating the relationship between the timing of dietary acid intake toothbrushing and erosive tooth wear. Data will be collected on the timing, nature, frequency and duration of dietary acid intakes and timing and frequency of the participants toothbrushing. Signs of the participants erosive tooth wear will then be recorded', 'detailedDescription': "The study group will consist of two cohorts, those presenting with tooth wear and a control group. Participants will be recruited from the care planning clinic of the Dental Institute King's College London. Suitable participants meeting the inclusion criteria will be approached on the clinic, given the patient information sheet and asked to consider participating. Written consent will be obtained from those accepting the request. An interviewer-led, previously validated questionnaire will question their frequency and timing of dietary acid intake, tooth brushing and any habits associated with dietary acid intake. This will be followed by a Basic Erosive Wear Examination.\n\nThe process will take 7-8 minutes and the participant is free to withdraw at any time"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients referred into the Dental institute of King's College London for dental treatment", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Severe tooth wear with a BEWE score of 12 and at least one score of 3 in three quadrants\n2. Adult 18 years or older\n3. No missing anterior teeth\n4. minimum of at 10 teeth in the upper and 10 teeth in the lower jaw\n5. No anterior crowns/ bridges or implants\n6. Written consent to the study\n\nExclusion Criteria:\n\n1. Pregnancy\n2. Participation in other research within 30 days\n3. Unable to speak or understand English\n4. Presence of periodontal disease or caries on more than one tooth'}, 'identificationModule': {'nctId': 'NCT02449434', 'briefTitle': 'Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.', 'organization': {'class': 'OTHER', 'fullName': "King's College London"}, 'officialTitle': 'Timing of Dietary Acid Intake, Brushing Teeth and Acid Erosion.', 'orgStudyIdInfo': {'id': 'RJ114/N205'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe Tooth Wear', 'description': 'Severe tooth wear with a BEWE score of 12 and at least one score of 3 in three quadrants Adult 18 years or older No missing anterior teeth Minimum of at 10 teeth in the upper and 10 teeth in the lower jaw No anterior crowns/ bridges or implants Written consent to the study\n\nThere was no intervention - just a questionnaire for each group'}, {'label': 'Without Tooth Wear', 'description': 'BEWE score of 10 or lower and no score of 3 on any surface of any tooth (clinically classified as no or mild erosive tooth wear) Adult 18 years or older No missing anterior teeth Minimum of at 10 teeth in the upper and 10 teeth in the lower jaw No anterior crowns/ bridges or implants Written consent to the study\n\nThere was no intervention - just a questionnaire for each group'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': "Dental Institute, Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'David Bartlett, BDS PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "King's College London"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "King's College London", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}