Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-25 @ 12:35 PM
Study NCT ID:
NCT06202495
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2024-01-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dentine Hypersensitivity Treated With Laser and Fluoride.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D005459', 'term': 'Fluorides'}], 'ancestors': [{'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 43}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-07-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-18', 'studyFirstSubmitDate': '2024-01-01', 'studyFirstSubmitQcDate': '2024-01-01', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'NRS (numerical rating scale)', 'timeFrame': 'Before treatment and 1 week, 1 month, 3 months, 6 months after treatment', 'description': 'The dentine hypersensitivity will be evaluated with the Numerical Rating Scale ( NRS ), where 0 meant pain absence and 10 a unbearable pain (Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, et al. Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011;41(6):1073-93.)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dentine hypersensitivity', 'fluoride', 'laser'], 'conditions': ['Sensitive Dentin']}, 'descriptionModule': {'briefSummary': 'The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.\n\nNRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient after cold air blow stimulus.\n\nAfter treatment application, the follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months', 'detailedDescription': 'The aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity.\n\nThe study is designed with a split mouth design. NRS (numerical rating scale) index will be used to evaluate the pain suffered by each patient. The pain response will be stimulated by thermal urge (cold air blow). Teeth will be divided in two groups. The treatment group, treated with 980nm diode laser and amino fluoride gel; the control group, treated only with amino fluoride gel.\n\nThe follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months. In these follow-up sessions a revaluation of the pain response is performed using the NRS index.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Teeth in good periodontal health\n* Good oral hygiene\n* Dentine hypersensitivity: NRS (Numerical Rating Scale) ≥ 3\n\nExclusion Criteria:\n\n* Teeth local disease or fractures in treatment area\n* Irreversible teeth necrosis or pulpitis\n* Definitive restorations or veneers\n* Recent use of painkillers or anti-inflammatory drugs,\n* Treatment for dentine Hypersensitivity less than 6 months before the study start\n* Therapies contraindication'}, 'identificationModule': {'nctId': 'NCT06202495', 'briefTitle': 'Dentine Hypersensitivity Treated With Laser and Fluoride.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Dentine Hypersensitivity Treated With Diode Laser and Amino Fluoride: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2024-FLUORIDELASER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Laser and Fluoride', 'description': "The treatment group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface. For treatment will be used 400 μm diameter and 5 mm long tips of for 4 minutes", 'interventionNames': ['Device: Laser and Fluoride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoride', 'description': 'The control group will be treated with amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) for 4 minutes.', 'interventionNames': ['Other: Fluoride']}], 'interventions': [{'name': 'Laser and Fluoride', 'type': 'DEVICE', 'description': "topic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States) in association 980nm diode laser (doctor smile wiser by Lambda s.p.a. Via dell'Impresa, 1, 36040 Brendola VI, Italy) 1.5 W, pulsed mode 2 mm from tooth surface", 'armGroupLabels': ['Laser and Fluoride']}, {'name': 'Fluoride', 'type': 'OTHER', 'description': 'topic application of amino-fluoride gel (Elmex Dental Gel, Colgate-Palmolive company, New York, 300 Park Ave, United States)', 'armGroupLabels': ['Fluoride']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Catanzaro', 'country': 'Italy', 'facility': 'A.O. Mater Domini, U.O. Odontoiatria, University of Catanzaro "Magna Græcia".', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}], 'overallOfficials': [{'name': 'Andrea Scribante, DDS PhD MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unit of Dental Hygiene - Section of Dentistry - Dep of Clin Surg Diagn Ped Sci - University of Pavia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Andrea Scribante', 'investigatorAffiliation': 'University of Pavia'}}}}