Ignite Creation Date:
2025-12-24 @ 4:42 PM
Ignite Modification Date:
2025-12-28 @ 4:33 AM
Study NCT ID:
NCT04731766
Status:
UNKNOWN
Last Update Posted:
2021-02-01
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver 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': 'D012969', 'term': 'Sodium Fluoride'}], 'ancestors': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D002327', 'term': 'Cariostatic Agents'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-29', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2021-01-29', 'lastUpdatePostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in dentin Hypersensitivity', 'timeFrame': '1 week, 4 weeks & 8 weeks', 'description': 'Visual Analogue Scale (VAS) will be used; 0 is no pain and 10 is severe pain. Pictures are added to the same, as well as colors to guide the patient during selection of pain severity.'}], 'secondaryOutcomes': [{'measure': 'change in dentinal Tubule Occlusion', 'timeFrame': '1 week, 4 weeks * 8 weeks', 'description': 'the dentinal tubule occlusion of citrine 5% sodium fluoride and the dentinal tubule occlusion of nano-silver fluoride for treatment of dentin hypersensitivity and compare them together'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dentin Hypersensitivity']}, 'descriptionModule': {'briefSummary': '2 different varnishes will be used to test their effectiveness in controlling teeth hypersensitivity in adult patient.', 'detailedDescription': "In-vivo part:\n\nEach varnish will be applied separately on different teeth according to the manufacturer's instructions and the VAS will be measured according to a specific timeline: T0 (baseline, before application of varnish), T1 (1 week after application), T2 (4 weeks after application) and T3 (4 weeks after application).\n\nIn-situ part:\n\nDentin specimen will be prepared from extracted teeth from the orthodontic department in our college, sterilized and prepared.\n\nit will be bonded to an orthodontic wire and bonded to upper first molar. Dentinal occlusion will be measured using scanning electron microscope following the same timeline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients consulting in one of the Qasr Einy, faculty of dentistry outpatient clinics.\n* Males or females.\n* Patient's age range 25-50 years.\n* Patients complaining of hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bi-cuspids, and first molars with exposed cervical dentine) with teeth scoring Bpain (VAS score: greater than or equal to 3) during application of stimulus (airblast and tactile sensitivity test).\n* Tooth with exposed root surface, complaining from hypersensitivity (VAS score; greater than or equal to 3).\n* Patients accept the 2-months follow-up period.\n* Provide informed consent.\n\nExclusion Criteria:\n\n* • Patients participating in another dental study that may alter the results of this study.\n\n * A medical condition that could hinder the accuracy of pain reporting (e.g., pain disorders).\n * Any chronic medical condition that requires the regular use of anti-inflammatory pain medications.\n * Patients used or applied a desensitizing varnish within the last four weeks.\n * Patients with dental problems; chipped teeth, defective restorations, fractured Un-displaced cuspids or deep dental caries.\n * Lack of patient's approval and compliance."}, 'identificationModule': {'nctId': 'NCT04731766', 'briefTitle': 'Effect of Using Different Varnishes on Dentin Hypersensitivity; Na Fluoride and Nano-silver Fluoride', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effectiveness of Using Nano-Silver Fluoride Varnish Versus Sodium Fluoride Varnish in Management of Cervical Dentin Hypersensitivity in Adult Patients: A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '205'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Citrine 5% Sodium Fluoride', 'description': 'It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.', 'interventionNames': ['Behavioral: Citrine 5 % sodium fluoride']}, {'type': 'EXPERIMENTAL', 'label': 'concocuted Nano-silver fluoride', 'description': 'Nano-silver fluoride (NSF) is a laboratory synthesized solution', 'interventionNames': ['Behavioral: concocted nano-silver fluoride']}], 'interventions': [{'name': 'Citrine 5 % sodium fluoride', 'type': 'BEHAVIORAL', 'description': 'Citrine varnish is a 5% sodium fluoride varnish, It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.', 'armGroupLabels': ['Citrine 5% Sodium Fluoride']}, {'name': 'concocted nano-silver fluoride', 'type': 'BEHAVIORAL', 'description': "Nano-silver fluoride (NSF) is a solution which has been introduced as an experimental formulation in which it's stability for three years has been proved by Santos et al. The laboratory synthesis of concocted NSF was carried out in a nano-technology center; Several trials were done until we have reached a successful end product.", 'armGroupLabels': ['concocuted Nano-silver fluoride']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nayera Hassanien Mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Nayera Hassanien Mohamed', 'investigatorAffiliation': 'Cairo University'}}}}