Ignite Creation Date:
2025-12-24 @ 2:24 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT03120559
Status:
COMPLETED
Last Update Posted:
2017-04-19
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001519', 'term': 'Behavior'}, {'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'], 'maskingDescription': 'The researcher was blind to the patients'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-15', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-15', 'lastUpdatePostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from BOMP (Bleeding on Marginal Probing) at 4 months', 'timeFrame': 'Baseline & 4 months', 'description': 'Gingival bleeding Index'}], 'secondaryOutcomes': [{'measure': 'HAPA behavioral variables questionnaire.', 'timeFrame': 'Baseline & 4 months', 'description': 'Assessment of HAPA variables (same 5 points Likert scale for each of the variables)'}, {'measure': 'SMS opinion questionnaire', 'timeFrame': '4 months', 'description': 'Opinion about receiving SMS and how can it influence the appointment'}, {'measure': 'Self-report Dental Hygiene Behaviors questionnaire.', 'timeFrame': 'Baseline & 4 months', 'description': 'Level of tooth-brushing and dental floss frequency.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gingivitis', 'SMS', 'Dental floss', 'behavior change', 'HAPA'], 'conditions': ['Behavior', 'Gingivitis']}, 'referencesModule': {'references': [{'pmid': '7806674', 'type': 'BACKGROUND', 'citation': 'Van der Weijden GA, Timmerman MF, Nijboer A, Reijerse E, Van der Velden U. Comparison of different approaches to assess bleeding on probing as indicators of gingivitis. J Clin Periodontol. 1994 Oct;21(9):589-94. doi: 10.1111/j.1600-051x.1994.tb00748.x.'}]}, 'descriptionModule': {'briefSummary': 'This study proposes to evaluate the effects of using a new floss holder (GumChuck) and the use of text messages during supportive periodontal therapy, on the psychological, behavioral and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework.', 'detailedDescription': "Despite evidence on the benefits of controlling dental biofilm for preventing gingivitis, patients have difficulty complying. Floss holder devices and SMS may be useful in enhancing both the frequency and effectiveness of dental hygiene behaviors, by increasing patients' motivation and self-regulation efforts, but scarce scientific literature supporting their worth in controlling gingivitis and the underlying psychological processes is currently available."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Gingivitis BOMP \\> 0.5\n* 20 teeth (minimum 5 per quadrant)\n* \\> 18 years old\n\nExclusion Criteria:\n\n* periodontitis (pockets \\>3),\n* smoking,\n* orthodontics,\n* pregnancy\n* removable partial dentures'}, 'identificationModule': {'nctId': 'NCT03120559', 'briefTitle': 'Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder', 'organization': {'class': 'OTHER', 'fullName': 'University of Lisbon'}, 'officialTitle': 'Can we Still Save Dental Floss? Improving Dental Floss Adherence and Gingival Health With SMS and an Innovative Floss Holder in a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '07/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'The dental consultation was the same for all the groups.\n\n1. \\- Examination and diagnosis (15 min).\n2. \\- Motivation, discussion about desired outcomes and treatment needs followed by instrumentation (scaling, polishing) (30 min).\n3. \\- Therapeutic goals, therapeutic strategies, teaching skills (brushing and interproximal control with regular waxed floss at the Control group) and scheduling of the follow-up appointment (15 min).\n\nThey were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The consultation time was 60 minutes and also included specific behavior change techniques, such as reinforcement, goal-setting, and feedback.'}, {'type': 'OTHER', 'label': 'NFH - New Floss Holder', 'description': 'The dental consultation was the same for all the groups. They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The consultation time was 60 minutes and also included specific behavior change techniques, such as reinforcement, goal-setting, and feedback. New Floss Holder - Gum Chucks', 'interventionNames': ['Device: New Floss Holder - Gum Chucks']}, {'type': 'OTHER', 'label': 'New Floss Holder and Short Messages', 'description': 'The dental consultation was the same for all the groups. They were properly organized in accordance with the features of each patient, such as their gingival condition, gingivitis perception, habits and expectancies concerning the treatment. The Intervention time was 60 minutes and also included behavior change techniques, such as reinforcement, goal-setting, and feedback. Participants in the NFH/SMS group further received a total of 16 messages (SMS).\n\nNew Floss Holder - Gum Chucks/SMS', 'interventionNames': ['Device: New Floss Holder - Gum Chucks/SMS']}], 'interventions': [{'name': 'New Floss Holder - Gum Chucks', 'type': 'DEVICE', 'description': 'Dental inter-proximal control with GumChucks floss holder', 'armGroupLabels': ['NFH - New Floss Holder']}, {'name': 'New Floss Holder - Gum Chucks/SMS', 'type': 'DEVICE', 'description': 'Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.', 'armGroupLabels': ['New Floss Holder and Short Messages']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Lisbon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master in Health Psychology', 'investigatorFullName': 'Mario Rui Araújo', 'investigatorAffiliation': 'University of Lisbon'}}}}