Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-31 @ 1:17 PM
Study NCT ID:
NCT04527159
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2020-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Desensitizing Materials
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': 'C525245', 'term': 'VivaSens Liner'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-02-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-30', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-21', 'lastUpdatePostDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Likert type scale used to measure attitudes or opinions', 'timeFrame': '24 Hours', 'description': 'Likert type scale grading from 0-4 0: No sensitivity\n\n1. Very mild sensitivity\n2. Mild sensitivity\n3. Moderate Sensitivity\n4. Severe Sensitivity to compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dentin Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'To compare the efficacy of two commercially available in-office desensitizing agents (Fluoraphat Pro and VivaSens®), in the treatment of dentinal hypersensitivity.', 'detailedDescription': 'Dentine hypersensitivity (DH) is a condition that occurs in non-pathological, non-defective teeth and is defined as "a short, sharp pain in response to stimuli, typically thermal, evaporative, tactile, osmotic or chemical and which cannot be attributed to any other dental defect or pathology". The incidence of DH ranges from 4% to 74% in several studies. Mandibular first molars, canines and premolars of both jaws are most commonly affected by DH.\n\nThe pathogenesis of DH is linked to exposure of dentinal tubules that can occur in the oral cavity due to dental erosion from acidogenic diets, aggressive tooth-brushing, injudicious use of whitening products, gingival recession, periodontal debridement or surgery. The most commonly reported initiating factor is cold drinks. Management usually involves methods that can achieve one or both of the following objectives; i) alteration of fluid flow in the dentinal tubules and ii) modification or blocking of the pulpal nerve response.\n\nA broad range of products that achieve these objectives have been developed after rigorous trials and can be used in-office or at home depending on the severity of the condition. These products are commonly referred to as desensitizing agents. Grossman suggested that an ideal desensitizing agent should be non-irritating to the pulp, relatively painless on application, easy to apply, rapid in action, effective for long periods of time and should not stain the teeth.\n\nThe use of dentine desensitizers has become one of the most common methods in managing DH. The most commonly used desensitizers contain components such as fluoride, triclosan, benzalkonium chloride, ethylene diaminetetraacetic acid and glutaraldehyde. Fluoraphat Pro (Neumunster, Germany) and VivaSens® (Ivoclar Vivadent, Schaan, Liechtenstein, Switzerland) are two agents that have been tested for use as dentine desensitizers and are currently available for commercial use. In the present study, two such varnishes VivaSens (Ivoclar Vivadent, Schaan, Liechtenstein, and Switzerland) and Fluoraphat (Promedical Neumunster, Germany) have been used. The present study aims to establish which of the two desensitizing agents has better efficacy in reducing hypersensitivity in patients who have been previously diagnosed with DH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Gender and Age are not included in the calculation, since the effects could not be determined reliably', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males and females aged between 18 and 50 years\n* Patient should have at least 2 teeth with dentinal hypersensitivity\n* Sound tooth structure\n* Willingness to participate in the study\n\nExclusion Criteria:\n\n* Gingival recession\n* Caries\n* Non-carious lesions (attrition, abrasion, erosion, abfraction)\n* Teeth restored with dental filling\n* Fractured or cracked tooth\n* Microleakage'}, 'identificationModule': {'nctId': 'NCT04527159', 'briefTitle': 'Comparison of Desensitizing Materials', 'organization': {'class': 'OTHER', 'fullName': 'Riyadh Elm University'}, 'officialTitle': 'Comparison Between Two Different Desensitizing Materials in Controlling Natural Dentin Hypersensitivity: A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'dentin hypersensitivity'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'desensitizing agents (Fluoraphat Pro and VivaSens®)', 'description': '22 participants above the age of 18 years who presented to dental clinics in Riyadh Elm University with dentine hypersensitivity were randomly selected to participate in the study.\n\nEach participant has at least two teeth with natural hypersensitivity which was not caused by any iatrogenic causes or bad oral habits, so there are 44 cases divided into two groups according to the material used, each group has 22 teeth, that make it applicable to apply the studied material with every patient on individual tooth with the same variables of the oral mouth. When teeth in the hypersensitivity group were evaluated for the level of DH, all teeth were found to have Grade 4 sensitivity.', 'interventionNames': ['Drug: Fluoraphat Pro / VivaSens']}], 'interventions': [{'name': 'Fluoraphat Pro / VivaSens', 'type': 'DRUG', 'otherNames': ['VivaSens'], 'description': 'desensitizing agents for treatment of dentinal hypersensitivity', 'armGroupLabels': ['desensitizing agents (Fluoraphat Pro and VivaSens®)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13311', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Nourah Aljasser', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'overallOfficials': [{'name': 'Roula Alboouni, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Riyadh Elm University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nourah Mulfi Aljasser', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nourah Mulfi Aljasser', 'investigatorAffiliation': 'Riyadh Elm University'}}}}