Ignite Creation Date:
2025-12-25 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 10:10 PM
Study NCT ID:
NCT03571958
Status:
COMPLETED
Last Update Posted:
2022-04-21
First Post:
2018-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief Motivational Interviewing (BMI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2018-06-18', 'studyFirstSubmitQcDate': '2018-06-18', 'lastUpdatePostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Clinical attachment level', 'timeFrame': 'Recorded four times over a one year time frame', 'description': 'Measured in millimeters'}], 'primaryOutcomes': [{'measure': 'Plaque score', 'timeFrame': 'Recorded four times over a one year time frame', 'description': 'Excellent hygiene: 0-20%, Good hygiene: 21-40%, Fair hygiene: 41-60%, Poor hygiene: 61-100%'}, {'measure': 'Bleeding on probing (BOP)', 'timeFrame': 'Recorded four times over a one year time frame', 'description': 'Presence of bleeding (yes) or absent of bleeding (no)'}, {'measure': 'Gingival Index', 'timeFrame': 'Recorded four times over a one year time frame', 'description': '0= normal gingiva, 1=mild inflammation (no BOP), 2=moderate inflammation (BOP), 3=severe inflammation (spontaneous bleeding)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Motivational Interviewing, BMI, OHI']}, 'descriptionModule': {'briefSummary': "The goal of this research study is to determine if the utilization of brief motivational interviewing (BMI) during continuous care is superior compared to traditional oral hygiene instruction (OHI) to reduce patients' plaque score, bleeding on probing (BOP), and gingival index (GI) longitudinal. An additional goal is to investigate chairside time of implementing BMI."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or Female\n* ≥ 18 years old\n* Periodontal maintenance phase (at least one year)\n* Plaque score ≥30% (O'Leary plaque score)\n* Minimum of two sites with BOP\n* Willingness to fulfill all study requirements\n* Patient of Record at the University of Minnesota School of Dentistry\n\nExclusion Criteria:\n\n* Current smoker or quit smoking less than one year\n* Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)\n* Uncontrolled diabetes (HbA1C \\> 7)\n* Medical conditions that may influence the outcome of the study (neurologic or psychiatric disorders, systemic infections, cancer, and/or HIV/AIDS)\n* Current use of oral bisphosphonates\n* History of IV bisphosphonates\n* Require pre-medication or on long-term antibiotics\n* Current orthodontic treatment or planning to begin orthodontic treatment during the study\n* Unable to comply with the study protocol"}, 'identificationModule': {'nctId': 'NCT03571958', 'briefTitle': 'Brief Motivational Interviewing (BMI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Impact of Brief Motivational Interviewing During Continuous Patient Care to Enhance Oral Hygiene', 'orgStudyIdInfo': {'id': 'DENT-2018-26921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Traditional OHI (Control)', 'description': 'Advice giving method of OHI known as "tell-show-do" to inform, demonstrate, and expect patient compliance.'}, {'type': 'EXPERIMENTAL', 'label': 'BMI (Test)', 'description': "A derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change. BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change.", 'interventionNames': ['Behavioral: BMI']}], 'interventions': [{'name': 'BMI', 'type': 'BEHAVIORAL', 'description': "A derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change. BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change.", 'armGroupLabels': ['BMI (Test)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'School of Dentistry', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Michelle Arnett, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}