Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-07 @ 7:22 PM
Study NCT ID:
NCT02160418
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2014-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Incentives for Daily Tooth Brushing to Reduce Gingivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005891', 'term': 'Gingivitis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D005882', 'term': 'Gingival Diseases'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 152}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2014-06-03', 'studyFirstSubmitQcDate': '2014-06-06', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Follow-up Gingival Index', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Frequency and duration of toothbrushing', 'timeFrame': '3 months'}, {'measure': 'End of treatment Gingival Index', 'timeFrame': '3 months', 'description': 'Gingival Index at the end of behavioral incentives'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gingivitis']}, 'descriptionModule': {'briefSummary': 'In this randomized controlled study, the investigators compare two classes of behavioral approaches to change habits and health outcomes with an application to dental health: cognitive vs. behavioral financial incentives. Under cognitive incentives subjects are paid to correctly answer health-related quizzes. Under behavioral incentives subjects earn money for making healthy choices. The investigators apply these incentives to toothbrushing, a daily health-related behavior critical to the prevention of dental caries and periodontal disease, two high-burden conditions among US adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female older than 18 years, with at least 10 teeth present.\n\nExclusion Criteria:\n\n* Pregnancy, uncontrolled diabetes, systemic antibiotics taken within the previous 2 months, need for referral for periodontal treatment.'}, 'identificationModule': {'nctId': 'NCT02160418', 'briefTitle': 'Incentives for Daily Tooth Brushing to Reduce Gingivitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'orgStudyIdInfo': {'id': '819853'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '36 Participants will be sent a new toothbrush and will be asked to use it in place of their current brush. They also receive twice daily reminders via sms to brush their teeth.'}, {'type': 'EXPERIMENTAL', 'label': 'Financial Incentives', 'description': '36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. They will also be offered financial incentives twice a day to brush their teeth.', 'interventionNames': ['Behavioral: Financial Incentives']}, {'type': 'EXPERIMENTAL', 'label': 'Cognitive Incentives', 'description': '36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. Twice a week, they will receive text messages (SMS) with a short quiz question related to oral hygiene behavior and oral health. Participants will receive a reward if they answer correctly via text message.', 'interventionNames': ['Behavioral: Cognitive Incentives']}, {'type': 'EXPERIMENTAL', 'label': 'Financial and Cognitive Incentives', 'description': '36 Participants will receive a toothbrush and twice daily reminders to brush their teeth. Twice daily they receive financial incentives to brush their teeth. Twice a week, they will receive text messages (SMS) with a short quiz question related to oral hygiene behavior and oral health. Participants will receive a reward if they answer correctly via text message.', 'interventionNames': ['Behavioral: Financial and Cognitive Incentives']}], 'interventions': [{'name': 'Financial Incentives', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Financial Incentives']}, {'name': 'Cognitive Incentives', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Cognitive Incentives']}, {'name': 'Financial and Cognitive Incentives', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Financial and Cognitive Incentives']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}