Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-01-01 @ 11:58 AM
Study NCT ID:
NCT03330535
Status:
UNKNOWN
Last Update Posted:
2018-12-31
First Post:
2017-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Active Reminders on Oral Hygiene in Orthodontics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Four groups of participants will be formulated. Each will will receive messages in different time interval starting from none, once a week, three times a week and daily.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-27', 'studyFirstSubmitDate': '2017-10-31', 'studyFirstSubmitQcDate': '2017-10-31', 'lastUpdatePostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plaque Index', 'timeFrame': 'At baseline, 4 weeks and 8 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, 4 weeks and 8 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': ['Oral Hygiene']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.', 'detailedDescription': 'Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants were having orthodontic fixed appliance treatment.\n* Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.\n* Participants were willing to comply with given oral hygiene instructions.'}, 'identificationModule': {'nctId': 'NCT03330535', 'briefTitle': 'The Effect of Active Reminders on Oral Hygiene in Orthodontics', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Colleges of Dentistry and Pharmacy'}, 'officialTitle': 'The Effect of Active Reminders on Oral Hygiene of Patients With Fixed Orthodontic Appliances With Different Time Intervals', 'orgStudyIdInfo': {'id': 'FRP/2018/27'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Verbal oral hygiene instructions', 'description': 'Participants will receive verbal oral hygiene instructions during routine orthodontic visits.', 'interventionNames': ['Behavioral: Verbal oral hygiene instructions']}, {'type': 'EXPERIMENTAL', 'label': 'Reminders once a week', 'description': 'Participants will receive active reminders once a week.', 'interventionNames': ['Behavioral: Reminders once a week']}, {'type': 'EXPERIMENTAL', 'label': 'Reminders three times a week', 'description': 'Participants will receive active reminders three times a week.', 'interventionNames': ['Behavioral: Reminders three times a week']}, {'type': 'EXPERIMENTAL', 'label': 'Daily reminders', 'description': 'Participants will receive active reminders daily.', 'interventionNames': ['Behavioral: Daily reminders']}], 'interventions': [{'name': 'Reminders once a week', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will receive active oral hygiene reminders through text messaging once a week.', 'armGroupLabels': ['Reminders once a week']}, {'name': 'Verbal oral hygiene instructions', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will receive verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.', 'armGroupLabels': ['Verbal oral hygiene instructions']}, {'name': 'Reminders three times a week', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will receive active oral hygiene reminders through text messaging three times a week.', 'armGroupLabels': ['Reminders three times a week']}, {'name': 'Daily reminders', 'type': 'BEHAVIORAL', 'description': 'Participants in this group will receive active oral hygiene reminders through text messaging on a daily basis.', 'armGroupLabels': ['Daily reminders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11681', 'city': 'Riyadh', 'state': 'Riyadh Region', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Omar AlKadhi', 'role': 'CONTACT'}], 'facility': 'Riyadh Elm University', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Omar H Alkadhi, BDS,MS', 'role': 'CONTACT', 'email': 'omar.alkadhi@riyadh.edu.sa', 'phone': '966505154754'}, {'name': 'Ahmed A Bahamid, BDS,MS', 'role': 'CONTACT', 'email': 'ahmed.bahamid@riyadh.edu.sa', 'phone': '+966504461888'}], '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 in Orthodontics and Clinic Director', 'investigatorFullName': 'Omar Alkadhi', 'investigatorAffiliation': 'Riyadh Colleges of Dentistry and Pharmacy'}}}}