Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 6:57 PM
Study NCT ID:
NCT02829567
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2016-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Motivational Interviewing in Orthodontic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D062405', 'term': 'Motivational Interviewing'}], 'ancestors': [{'id': 'D037001', 'term': 'Directive Counseling'}, {'id': 'D003376', 'term': 'Counseling'}, {'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2016-06-26', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess change in oral hygiene using plaque index Löe & Silness', 'timeFrame': 'Baseline, 1 month and 6 months', 'description': 'Plaque index Löe \\& Silness (Time: baseline, 1 month and 6 months)'}], 'secondaryOutcomes': [{'measure': 'Assess change in oral hygiene using gingival index Löe & Silness', 'timeFrame': 'Baseline, 1 month and 6 months', 'description': 'Gingival index Löe \\& Silness ( Time: baseline, 1 month and 6 months)'}]}, 'conditionsModule': {'conditions': ['Oral Hygiene']}, 'referencesModule': {'references': [{'pmid': '19328605', 'type': 'BACKGROUND', 'citation': 'Martins RK, McNeil DW. Review of Motivational Interviewing in promoting health behaviors. Clin Psychol Rev. 2009 Jun;29(4):283-93. doi: 10.1016/j.cpr.2009.02.001. Epub 2009 Feb 23.'}, {'pmid': '30198774', 'type': 'DERIVED', 'citation': 'Rigau-Gay MM, Claver-Garrido E, Benet M, Lusilla-Palacios P, Ustrell-Torrent JM. Effectiveness of motivational interviewing to improve oral hygiene in orthodontic patients: A randomized controlled trial. J Health Psychol. 2020 Nov-Dec;25(13-14):2362-2373. doi: 10.1177/1359105318793719. Epub 2018 Sep 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether motivational interviewing is effective in improving oral hygiene in orthodontic patients wearing fixed appliances.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Orthodontic patients wearing fixed appliances, within the first six months of treatment\n* Eruption completed (except for the third molars) or late mixed dentition.\n* Caucasian\n\nExclusion Criteria:\n\n* Pregnancy\n* Periodontal disease\n* Systemic illness\n* Medical treatment'}, 'identificationModule': {'nctId': 'NCT02829567', 'acronym': 'MIOrtho', 'briefTitle': 'Motivational Interviewing in Orthodontic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Barcelona'}, 'officialTitle': 'Effectiveness of Motivational Interviewing in Improving Oral Hygiene in Orthodontic Patients', 'orgStudyIdInfo': {'id': 'MI01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral hygiene counseling and motivational interviewing', 'description': 'This group will receive a session of oral hygiene counseling and a single session of motivational interviewing to increase the readiness of change.', 'interventionNames': ['Behavioral: Motivational interviewing']}, {'type': 'NO_INTERVENTION', 'label': 'Oral hygiene counseling'}], 'interventions': [{'name': 'Motivational interviewing', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Oral hygiene counseling and motivational interviewing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08907', 'city': "L'Hospitalet de Llobregat", 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Odontològic Universitat de Barcelona', 'geoPoint': {'lat': 41.35967, 'lon': 2.10028}}], 'overallOfficials': [{'name': 'Maria Montserrat Rigau Gay, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Barcelona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS', 'investigatorFullName': 'Maria Montserrat Rigau Gay', 'investigatorAffiliation': 'University of Barcelona'}}}}