Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-30 @ 4:14 AM
Study NCT ID:
NCT07323693
Status:
COMPLETED
Last Update Posted:
2026-01-07
First Post:
2025-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Efficacy of Using Bioactive Desensitizer Gel
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003807', 'term': 'Dentin Sensitivity'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-12-23', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog scale (VAS)', 'timeFrame': 'Change from the Baseline, 1 week, 1 months, 3 months, 6 months', 'description': 'A VAS is a line that is 10 cm in length, the extremes of which represent the limits of pain, a patient may experience an external stimulus (The left endpoint designated no pain was marked as 0 and the right endpoint designated sever pain was marked as 10). Patients will be asked to place a mark on the 10 cm line that indicated their dentin hypersensitivity intensity'}], 'secondaryOutcomes': [{'measure': 'Level of Pain Assessment using The Schiff sensitivity scale', 'timeFrame': 'Change from the Baseline, 1 week, 1 months, 3 months, 6 months', 'description': 'It was used to assess dentin hypersensitivity. A score of 0, 1, 2 or 3 was assigned 0 = no subject response to stimulus\n\n1. = subject response but will continue\n2. = subject responds and moves or requests discontinuation\n3. = painful response to stimulus, discontinuation requested.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dentin hypersentivity'], 'conditions': ['Dentin Desensitizing Agents', 'Dentin Hypersensitivity, Non-carious Cervical Lesions', 'Dentin Hypersensitivity']}, 'descriptionModule': {'briefSummary': 'To evaluate and compare the clinical effectiveness of a Bioactive Desensitizer Gel (which releases calcium and phosphate to form hydroxyapatite) versus a standard 5% Sodium Fluoride (NaF) Varnish in reducing cervical dentin hypersensitivity (CDH) in adult patients over a period of 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • With ≥1 sensitive tooth and with exposed dentin in the upper or lower dental arches.\n\n * Grade IV gingival recession.\n * Schiff sensitivity score needed to be ≥2, indicating that application of a jet of air makes the patient respond and move or requests discontinuation of the stimuli application.\n\nExclusion Criteria:\n\n* • Domestic or in-office fluoride application and bleaching 6 months before beginning of treatment\n\n * Long-term use of anti-inflammatory, analgesic and psychotropic drugs.\n * Allergies to product ingredients\n * Eating disorders, systemic conditions that cause or predispose patients to develop dentin hypersensitivity (for example, gastroesophageal reflux disease, GERD)\n * Excessive dietary or environmental exposure to acids.\n * Orthodontic appliance treatment within the previous three months.\n * Periodontal surgery within the previous three months before the study'}, 'identificationModule': {'nctId': 'NCT07323693', 'briefTitle': 'Clinical Efficacy of Using Bioactive Desensitizer Gel', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Clinical Efficacy of Using Bioactive Desensitizer Gel Versus Sodium Fluoride Varnish on Cervical Dentin Hypersensitivity in Adult Patients: A 6m Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Cons 25/4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bioactive Desenstizer', 'description': 'A micro-brush applicator was saturated with the material (Predicta Bioactive Desensitizer Gel) and massaged it into the tooth for 30-40 secs.Using a rubbing motion was used to liquefy the gel and allow it to penetrate the surface', 'interventionNames': ['Procedure: Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'sodium fluoride varnish', 'interventionNames': ['Procedure: Treatment']}], 'interventions': [{'name': 'Treatment', 'type': 'PROCEDURE', 'description': 'A micro-brush applicator was saturated with the material (Predicta Bioactive Desensitizer Gel) and massaged it into the tooth for 30-40 secs. Using a rubbing motion was used to liquefy the gel and allow it to penetrate the surface', 'armGroupLabels': ['Bioactive Desenstizer']}, {'name': 'Treatment', 'type': 'PROCEDURE', 'description': 'the sodium fluoride (Proshield) varnish, was painted with a disposable micro-brush on the sensitive surface as per the instructions for 60 seconds from the manufacturer.', 'armGroupLabels': ['sodium fluoride varnish']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Conservative dentistry department, Faculty of Dentistry, Cairo University', 'investigatorFullName': 'Rawda Hesham Abd ElAziz', 'investigatorAffiliation': 'Cairo University'}}}}