Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-26 @ 12:38 AM
Study NCT ID:
NCT04422860
Status:
UNKNOWN
Last Update Posted:
2020-07-13
First Post:
2020-06-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remineralization Efficacy of Gum Arabic Varnish.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003731', 'term': 'Dental Caries'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006170', 'term': 'Gum Arabic'}], 'ancestors': [{'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D053147', 'term': 'Plant Exudates'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2021-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2020-06-04', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remineralization through determination of lesion progression or regression', 'timeFrame': 'Change from baseline at 3,6, 9 months', 'description': 'Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion.'}], 'secondaryOutcomes': [{'measure': 'Caries lesion activity assessment', 'timeFrame': 'Change from baseline at 3,6, 9 months', 'description': 'Visual (change in Surface Appearance) - tactile ( change in Tactile Feeling of the surface by an explorer)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Initial carious lesion', 'Gum Arabic', 'Remineralization power', 'fluoride varnish', 'Mi varnish', 'Acacia senegal'], 'conditions': ['Caries,Dental', 'Remineralization', 'White Spot Lesion']}, 'referencesModule': {'references': [{'pmid': '30296788', 'type': 'BACKGROUND', 'citation': 'Philip N. State of the Art Enamel Remineralization Systems: The Next Frontier in Caries Management. Caries Res. 2019;53(3):284-295. doi: 10.1159/000493031. Epub 2018 Oct 8.'}, {'pmid': '18036508', 'type': 'BACKGROUND', 'citation': 'Onishi T, Umemura S, Yanagawa M, Matsumura M, Sasaki Y, Ogasawara T, Ooshima T. Remineralization effects of gum arabic on caries-like enamel lesions. Arch Oral Biol. 2008 Mar;53(3):257-60. doi: 10.1016/j.archoralbio.2007.10.004. Epub 2007 Nov 26.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '17 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with initial carious lesions.\n* Proper Oral hygiene.\n\nExclusion Criteria:\n\n* Patients with a compromised medical history.\n* Patients with active severe periodontal disease.\n* Patients with hypoplastic or hypomineralized teeth.'}, 'identificationModule': {'nctId': 'NCT04422860', 'briefTitle': 'Remineralization Efficacy of Gum Arabic Varnish.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled Clinical Trial.', 'orgStudyIdInfo': {'id': 'CEBD-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gum Arabic varnish', 'description': 'Gum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization.', 'interventionNames': ['Drug: Gum Arabic varnish']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium Fluoride varnish', 'description': 'The gold standard remineralizing agent recommended by the guidelines.', 'interventionNames': ['Drug: Proflourid Varnish,VOCO']}, {'type': 'ACTIVE_COMPARATOR', 'label': '10% w/v CPP-ACP, 5% sodium fluoride varnish', 'description': 'CPP-ACP is the most studied non fluoride remineralizing agent.', 'interventionNames': ['Drug: MI Varnish,GC Japan Inc.']}], 'interventions': [{'name': 'Gum Arabic varnish', 'type': 'DRUG', 'otherNames': ['Acacia senegal'], 'description': 'Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).', 'armGroupLabels': ['Gum Arabic varnish']}, {'name': 'Proflourid Varnish,VOCO', 'type': 'DRUG', 'description': '5% NaF varnish', 'armGroupLabels': ['Sodium Fluoride varnish']}, {'name': 'MI Varnish,GC Japan Inc.', 'type': 'DRUG', 'description': 'CPP-ACP with fluoride based varnish', 'armGroupLabels': ['10% w/v CPP-ACP, 5% sodium fluoride varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11331', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Rawda H. A.ElAziz, Post Phd', 'role': 'CONTACT', 'email': 'rawda.hesham@dentistry.cu.edu.eg', 'phone': '00201001097200'}, {'name': 'Ahmed H. Samaha, BSc', 'role': 'CONTACT', 'email': 'Ahmed.hesham@dentistry.cu.edu.eg'}], 'overallOfficials': [{'name': 'Rawda H. A.ElAziz, Post Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer at faculty of Dentistry- Cairo University'}, {'name': 'Rasha R Hassan', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant Professor at faculty of Dentistry- Cairo University'}, {'name': 'Ahmed H. Samaha, BSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Master's Degree student at faculty of Dentistry- Cairo University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Master's Degree Student- Faculty of Dentistry", 'investigatorFullName': 'Ahmed Hesham samaha', 'investigatorAffiliation': 'Cairo University'}}}}