Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-08 @ 6:16 AM
Study NCT ID:
NCT03285360
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2017-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Dentin Hypersensitivity'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2017-09-14', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain due to dentin hypersensitivity (evaporative stimulus)', 'timeFrame': '2 minutes after treatment', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS'}], 'secondaryOutcomes': [{'measure': 'Pain due to dentin hypersensitivity (evaporative stimulus)', 'timeFrame': '1 week', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (evaporative stimulus)', 'timeFrame': '2 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (evaporative stimulus)', 'timeFrame': '3 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (evaporative stimulus)', 'timeFrame': '4 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (evaporative stimulus)', 'timeFrame': '6 months', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (evaporative stimulus)', 'timeFrame': '12 months', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by air blast measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (tactile stimulus)', 'timeFrame': '2 minutes after treatment', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (tactile stimulus)', 'timeFrame': '1 week', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (tactile stimulus)', 'timeFrame': '2 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (tactile stimulus)', 'timeFrame': '3 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (tactile stimulus)', 'timeFrame': '4 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (tactile stimulus)', 'timeFrame': '6 months', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (tactile stimulus)', 'timeFrame': '12 months', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by tactile stimulation with a probe measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (thermal stimulus)', 'timeFrame': '2 minutes after treatment', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (thermal stimulus)', 'timeFrame': '1 week', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (thermal stimulus)', 'timeFrame': '2 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (thermal stimulus)', 'timeFrame': '3 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (thermal stimulus)', 'timeFrame': '4 weeks', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (thermal stimulus)', 'timeFrame': '6 months', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS'}, {'measure': 'Pain due to dentin hypersensitivity (thermal stimulus)', 'timeFrame': '12 months', 'description': 'Pain arising from dentin hypersensitivity in non-carious lesions stimulated by cold water measured by a 10 cm visual analogue scale VAS'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bifluoride, sylc, hypersensitivity,'], 'conditions': ['Hypersensitivity Dentin', 'Tooth Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'Will the use of Bioactive glass with air abrasion technology (Sylc) compared to Fluoride Varnish (Biflourid 10) affects the degree of pain in patients complaining from hypersensitivity due to non-carious lesions?', 'detailedDescription': '* Population: Patients complaining from Dentin Hypersensitivity due to non-carious lesions.\n* Intervention: Sylc, Air Abrasion Bioactive glass (Denfotex Research Ltd.)\n* Comparison: BiFlourid 10, Fluoride Varnish (VOCO, Germany)\n* Outcome measures: Dentin Hypersensitivity\n\nOutcome name Measuring device Measuring unit Dentin Hypersensitivity\n\n* Thermal\n* Tactile\n* Evaporative'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females.\n* Age: 18-70 years old.\n* Patients with good oral hygiene.\n* Co-operative patients who show interest to participate in the study.\n\nExclusion Criteria:\n\n* Patients with bad oral hygiene.\n* Patients with orthodontic appliances, or bridge work that might interfere with evaluation.\n* Patients who did any periodontal surgeries within the previous 6 months.\n* Patients who are allergic to any ingredients will be used in the study.\n* Pregnant and lactating women.'}, 'identificationModule': {'nctId': 'NCT03285360', 'briefTitle': 'Effectiveness of Bioactiveglass Air Abrasion Versus Fluoride Varnish in Management of Dentin Hypersensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effectiveness of Sylc Air Abrasion Bioactive Glass Technology Versus Fluoride Varnish Application in Management of Hypersensitivity of Non-Carious Cervical Lesions: Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'CairoU-DEzz'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'sylc bioactive glass', 'description': 'Sylc is a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment.\n\nSteps:\n\n1. Isolation: D.M. will make proper isolation for the teeth using cotton rolls.\n2. Hand piece: NSK Prophymate Neo will be used to deliver the powder particles on the sensitive areas. Air stream adjusted at 40-46 psi.\n3. Application: The hand piece will be held at constant distance (3-4mm) away from the tooth surface, with 60-80 degrees on the buccal surfaces. The powder will be applied for 5-10 seconds per tooth in a circular movement.\n4. Suction: High volume suction will be used on lingual side of the teeth to suck any particles, and avoid patient from swallowing it.', 'interventionNames': ['Combination Product: Sylc']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'fluoride varnish (Bifluorid 10)', 'description': 'fluoride varnish Bifluorid 10(by VOCO) will be used. It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.\n\nThe single dose form will be used, to make sure the amount of fluoride varnish used is standardized.\n\nSteps:\n\n1. Preparation: The tooth will be properly cleaned, and the surface will be air-dried.\n2. Dispensing: The foil will be pierced using a micro- tim, the opening will be enlarged, the brush will be wet in a circular movement.\n3. Application: Thin coat will be applied on the tooth surface. The varnish will be left from 10-20 seconds then air dried.\n\nConcerning the storage of the Bifluoride 10, it will be stored in refrigerator at the operative clinic to avoid exposure to high temperature or sunlight.', 'interventionNames': ['Combination Product: fluoride varnish (Bifluorid 10)']}], 'interventions': [{'name': 'Sylc', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Sylc bioactive glass'], 'description': 'a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment', 'armGroupLabels': ['sylc bioactive glass']}, {'name': 'fluoride varnish (Bifluorid 10)', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['Bifluorid 10'], 'description': 'It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.', 'armGroupLabels': ['fluoride varnish (Bifluorid 10)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': 'Faculty of dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina E Mohamed, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Dina Ezz', 'investigatorAffiliation': 'Cairo University'}}}}