Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-26 @ 6:42 AM
Study NCT ID:
NCT04203134
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Burning Mouth Syndrome Mouth Guard Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002054', 'term': 'Burning Mouth Syndrome'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009064', 'term': 'Mouth Protectors'}], 'ancestors': [{'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effectiveness in pain control', 'timeFrame': 'Baseline through 6 month', 'description': 'patient reported pain level using self reported word descriptor scale. Range from 0 - 5, with 0 as "no pain" and 5 as "excruciating pain"'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burning Mouth Syndrome', 'Burning Mouth']}, 'descriptionModule': {'briefSummary': 'This study will seek to test the effectiveness of a nonpharmacologic therapy for burning mouth syndrome (BMS). This nonpharmacologic therapy approach will be the fabrication a protective acrylic mouthguard for the maxillary arch and palate.', 'detailedDescription': 'The study involves a nonpharmacologic and non-invasive treatment method for BMS which will be administered randomly (flipping a coin) to half of the study subjects, (case group) in addition to normal condition treatment protocol for BMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• New patients diagnosed with BMS seen in the oral medicine clinic for the study period.\n\nExclusion criteria includes:\n\n• Patients with inconclusive diagnosis or evidence of underlying condition that may be causing oral burning therefore excluding BMS as a diagnosis\n\nInclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT04203134', 'briefTitle': 'Burning Mouth Syndrome Mouth Guard Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Protective Mouth Guards in Burning Mouth Syndrome (Prospective Study)', 'orgStudyIdInfo': {'id': 'IRB201902692'}, 'secondaryIdInfos': [{'id': 'OCR29702', 'type': 'OTHER', 'domain': 'University of Florida'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group', 'description': 'Patients in the randomly assigned treatment group will receive a mouthguard at first visit along with standard treatment of BMS.', 'interventionNames': ['Device: Mouthguard']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Control group will proceed through treatment for BMS in an otherwise standard treatment protocol and will not receive a mouthguard.'}], 'interventions': [{'name': 'Mouthguard', 'type': 'DEVICE', 'description': "The mouthguard is a thin clear acrylic protector fabricated from an impression of a patient's upper teeth and palate. The acrylic protector will be trimmed and will fit onto the patient's upper teeth and palate for use during the day, except when eating to minimize trauma to the tongue that exacerbates burning tongue pain.", 'armGroupLabels': ['Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida College of Dentistry', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Austin Belknap', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}