Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-04-24 @ 3:17 PM
Study NCT ID:
NCT03109769
Status:
COMPLETED
Last Update Posted:
2019-01-15
First Post:
2017-04-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Effect of Using Mobile Applications for Improving Oral Hygiene
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'omar.alkadhi@riyadh.edu.sa', 'phone': '966505154754', 'title': 'Omar Alkadhi', 'organization': 'Riyadh Colleges of Dentistry and Pharmacy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Mobile Phone Application', 'description': 'Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.\n\nMobile phone application', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Verbal Oral Hygiene Instructions', 'description': 'Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.\n\nVerbal oral hygiene instructions', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 0, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Plaque Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Phone Application', 'description': 'Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.\n\nMobile phone application'}, {'id': 'OG001', 'title': 'Verbal Oral Hygiene Instructions', 'description': 'Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.\n\nVerbal oral hygiene instructions'}], 'classes': [{'title': 'Plaque index at baseline', 'categories': [{'measurements': [{'value': '0.8050', 'spread': '0.4062', 'groupId': 'OG000'}, {'value': '0.8959', 'spread': '0.4824', 'groupId': 'OG001'}]}]}, {'title': 'Plaque index after 4 weeks', 'categories': [{'measurements': [{'value': '0.6677', 'spread': '0.3146', 'groupId': 'OG000'}, {'value': '0.9891', 'spread': '0.5244', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0444', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.\n\nThe null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.1373', 'estimateComment': 'Difference in plaque index within the first group (mobile phone application) at 4 weeks compared to baseline.\n\nThe mean difference was calculated as follows:\n\nplaque index at 4 weeks - plaque index at baseline', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0283', 'groupIds': ['OG000'], 'paramType': 'Median Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.0932', 'estimateComment': 'Difference in plaque index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.\n\nThe mean difference was calculated as follows:\n\nplaque index at 4 weeks - plaque index at baseline', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 4 weeks.', 'description': 'Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Gingival Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Mobile Phone Application', 'description': 'Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.\n\nMobile phone application'}, {'id': 'OG001', 'title': 'Verbal Oral Hygiene Instructions', 'description': 'Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.\n\nVerbal oral hygiene instructions'}], 'classes': [{'title': 'Gingival index at baseline', 'categories': [{'measurements': [{'value': '0.3450', 'spread': '0.2955', 'groupId': 'OG000'}, {'value': '0.4927', 'spread': '0.3005', 'groupId': 'OG001'}]}]}, {'title': 'Gingival index after 4 weeks', 'categories': [{'measurements': [{'value': '0.2273', 'spread': '0.2256', 'groupId': 'OG000'}, {'value': '0.5941', 'spread': '0.5679', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0283', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'The sample size was calculated as 44 participants. Sample size calculation was carried out through a pilot study on 30 participants with the group I mean=1.31, SD=0.39 and group II mean=1.62, SD=0.30, with ⍺=0.05 and 80% power.\n\nThe null hypothesis was: there is no difference in plaque index and gingival index between verbal oral hygiene instructions and oral hygiene instructions using mobile applications in patients with orthodontic fixed appliances.', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0002', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.1177', 'estimateComment': 'Difference in gingival index within the first group (mobile phone application) at 4 weeks compared to baseline.\n\nThe mean difference was calculated as follows:\n\ngingival index at 4 weeks - gingival index at baseline', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4809', 'groupIds': ['OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.1014', 'estimateComment': 'Difference in gingival index within the second group (verbal oral hygiene instructions) at 4 weeks compared to baseline.\n\nThe mean difference was calculated as follows:\n\ngingival index at 4 weeks - gingival index at baseline', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and after 4 weeks.', 'description': 'Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Mobile Phone Application', 'description': 'Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.\n\nMobile phone application'}, {'id': 'FG001', 'title': 'Verbal Oral Hygiene Instructions', 'description': 'Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.\n\nVerbal oral hygiene instructions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Mobile Phone Application', 'description': 'Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.\n\nMobile phone application'}, {'id': 'BG001', 'title': 'Verbal Oral Hygiene Instructions', 'description': 'Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.\n\nVerbal oral hygiene instructions'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '3.2', 'groupId': 'BG000'}, {'value': '17.2', 'spread': '5.2', 'groupId': 'BG001'}, {'value': '16.9', 'spread': '4.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Saudi Arabia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2017-04-05', 'resultsFirstSubmitDate': '2017-06-14', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-14', 'studyFirstPostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plaque Index', 'timeFrame': 'At baseline and after 4 weeks.', 'description': 'Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.'}, {'measure': 'Change in Gingival Index', 'timeFrame': 'At baseline and after 4 weeks.', 'description': 'Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliance Complication']}, 'referencesModule': {'references': [{'pmid': '28705122', 'type': 'DERIVED', 'citation': 'Alkadhi OH, Zahid MN, Almanea RS, Althaqeb HK, Alharbi TH, Ajwa NM. The effect of using mobile applications for improving oral hygiene in patients with orthodontic fixed appliances: a randomised controlled trial. J Orthod. 2017 Sep;44(3):157-163. doi: 10.1080/14653125.2017.1346746. Epub 2017 Jul 13.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to investigate the effect of the use of mobile phone application sending reminders to patients with orthodontic fixed appliances on oral hygiene.', 'detailedDescription': 'Subjects were randomized into two groups, the first group received a mobile application that sends active reminders notifications of oral hygiene. The second group received verbal oral hygiene instructions during their regular visits to the orthodontics clinics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participants were having orthodontic fixed appliance treatment.\n2. Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.\n3. Participants were willing to comply with given oral hygiene instructions.'}, 'identificationModule': {'nctId': 'NCT03109769', 'briefTitle': 'The Effect of Using Mobile Applications for Improving Oral Hygiene', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Colleges of Dentistry and Pharmacy'}, 'officialTitle': 'The Effect of Using Mobile Applications for Improving Oral Hygiene in Patients With Orthodontic Fixed Appliances: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FUGRP/2014/191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mobile phone application', 'description': 'Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day.', 'interventionNames': ['Behavioral: Mobile phone application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Verbal oral hygiene instructions', 'description': 'Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.', 'interventionNames': ['Behavioral: Verbal oral hygiene instructions']}], 'interventions': [{'name': 'Mobile phone application', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Mobile phone application']}, {'name': 'Verbal oral hygiene instructions', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Verbal oral hygiene instructions']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Omar H AlKadhi, BDS, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Riyadh Colleges of Dentistry and Pharmacy', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Omar Alkadhi', 'investigatorAffiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}}}}