Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT04340869
Status:
UNKNOWN
Last Update Posted:
2020-04-10
First Post:
2020-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents
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': 'D013805', 'term': 'Theobromine'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-09', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue scale pain score', 'timeFrame': '1 month', 'description': '0 = no pain to 10=severe exagerated pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dentin Sensitivity']}, 'descriptionModule': {'briefSummary': 'Treatment of Dentin Hypersensitivity Using Theobromine , Remin Pro , and Combination of Both Materials'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients that aged 18-50 years.\n* Patients in good general health.\n* Patients that have accessible teeth demonstrating signs of sensitivity.\n\nExclusion Criteria:\n\n* • Any chronic debilitating disease that could influence study outcomes.\n\n * Partial dentures, orthodontic appliances, implants or restorations in a poor state of repair that could influence study outcomes.\n * Intolerance or hypersensitivity to the study desensitizing agents or their ingredients.\n * Desensitising treatment or tooth bleaching within 8 weeks of screening.\n * Daily use of medications that might influence the perception of pain.('}, 'identificationModule': {'nctId': 'NCT04340869', 'briefTitle': 'Treatment of Dentin Hypersensitivity Using Different Desensitizing Agents', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'The Effect of Using Two Desensitizing Agents Alone and In Combination on Dentin Permeability and Hypersensitivity', 'orgStudyIdInfo': {'id': 'REC18-145'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Theobromine', 'description': 'Natural extract from Cocoa', 'interventionNames': ['Other: Theobromine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Remin Pro', 'description': 'Fluoride , Hydroxyapatite , and Xylitol', 'interventionNames': ['Other: Remin Pro']}, {'type': 'EXPERIMENTAL', 'label': 'Combination', 'description': 'Remin Pro and Theobromine', 'interventionNames': ['Other: Theobromine', 'Other: Remin Pro']}], 'interventions': [{'name': 'Theobromine', 'type': 'OTHER', 'description': 'Natural extract from Cocoa', 'armGroupLabels': ['Combination', 'Theobromine']}, {'name': 'Remin Pro', 'type': 'OTHER', 'description': 'Remin Pro', 'armGroupLabels': ['Combination', 'Remin Pro']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11111', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ebtsam Kassab', 'role': 'CONTACT', 'email': 'dentiebtsamkassab@gmail.com', 'phone': '+201005889938'}], 'facility': 'Al-Azhar University , Faculty of Dental medicine for Girls', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Ebtsam Kassab', 'role': 'CONTACT', 'email': 'dentiebtsamkassab@gmail.com', 'phone': '+201005889938'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'ebtsam kassab', 'investigatorAffiliation': 'Al-Azhar University'}}}}