Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-02 @ 8:50 AM
Study NCT ID:
NCT03725020
Status:
UNKNOWN
Last Update Posted:
2018-11-06
First Post:
2018-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of a Novel Fluoride Varnish in Preventing WSL During/After Treatment With Fixed Orthodontic Appliances
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2018-10-29', 'studyFirstSubmitQcDate': '2018-10-29', 'lastUpdatePostDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars', 'timeFrame': '12-24 months', 'description': 'Assessed from high-resolution digital photos'}], 'secondaryOutcomes': [{'measure': 'The secondary outcome is the prevalence of WSLs at debonding and one year after debond', 'timeFrame': '12 months', 'description': 'Assessed from high-resolution digital photos'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Orthodontics', 'Fixed appliance', 'White Spot Lesions', 'Fluoride varnish'], 'conditions': ['Orthodontic Appliance Complication']}, 'referencesModule': {'references': [{'pmid': '33009565', 'type': 'DERIVED', 'citation': 'Sonesson M, Brechter A, Lindman R, Abdulraheem S, Twetman S. Fluoride varnish for white spot lesion prevention during orthodontic treatment: results of a randomized controlled trial 1 year after debonding. Eur J Orthod. 2021 Aug 3;43(4):473-477. doi: 10.1093/ejo/cjaa055.'}, {'pmid': '31197364', 'type': 'DERIVED', 'citation': 'Sonesson M, Brechter A, Abdulraheem S, Lindman R, Twetman S. Fluoride varnish for the prevention of white spot lesions during orthodontic treatment with fixed appliances: a randomized controlled trial. Eur J Orthod. 2020 Jun 23;42(3):326-330. doi: 10.1093/ejo/cjz045.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the efficacy of a novel fluoride varnish (NFV) in preventing white spot lesion development in adolescents during and after treatment with fixed orthodontic appliances.', 'detailedDescription': 'The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debonding. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.\n\nDuring the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the test or the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth.\n\nThe pre- and post-treatment photos are projected on a screen (Hewlett Packard ProBook 6650b, Palo Alto CA, USA) in a dark room and the incidence and severity of enamel demineralization will be registered independently by two experienced and calibrated orthodontists according to the index of Gorelick et al. (1982).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criterion is a scheduled treatment with fixed maxillary appliances according a standard straight-wire concept (McLaughlin et al., 2001) during a period of at least 12 months\n\nExclusion Criteria:\n\n* In the event of long-term prescriptions of general antibiotics during the course of the study, this should be recorded separately'}, 'identificationModule': {'nctId': 'NCT03725020', 'briefTitle': 'Efficacy of a Novel Fluoride Varnish in Preventing WSL During/After Treatment With Fixed Orthodontic Appliances', 'organization': {'class': 'OTHER', 'fullName': 'Malmö University'}, 'officialTitle': 'Efficacy of a Novel Fluoride Varnish Formula in Preventing White Spot Lesions During and After Treatment With Fixed Orthodontic Appliances', 'orgStudyIdInfo': {'id': 'MalmoUSonesson'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoride varnish', 'description': 'During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply the test varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The NFV test varnish has mint flavour and the active ingredient is ammonium fluoride dissolved in ethanol, water and an acrylate polymer.', 'interventionNames': ['Other: Fluoride varnish']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Varnish without Fluoride', 'description': 'During the course of the orthodontic treatment, the patients are regularly checked every 6th week. At the end of each such occasion, the clinical staff will apply either the placebo varnish with a small brush in a thin layer around the base of the braces on the maxillary teeth. The varnish is let to dry and the subjects are instructed not to eat or drink within 60 minutes after the application. The placebo varnish has an identical composition as the test varnish except for the ammonium fluoride. Thus, taste, colour and handling properties are the same.', 'interventionNames': ['Other: Fluoride varnish']}], 'interventions': [{'name': 'Fluoride varnish', 'type': 'OTHER', 'description': 'The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debond. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.', 'armGroupLabels': ['Fluoride varnish', 'Varnish without Fluoride']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mikael Sonesson, Odont. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Malmö University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Malmö University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mikael Sonesson', 'investigatorAffiliation': 'Malmö University'}}}}