Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-01-18 @ 11:10 PM
Study NCT ID:
NCT04357093
Status:
COMPLETED
Last Update Posted:
2025-01-17
First Post:
2020-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.
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': 'D056604', 'term': 'Grape Seed Extract'}], 'ancestors': [{'id': 'D010936', 'term': 'Plant Extracts'}, {'id': 'D028321', 'term': 'Plant Preparations'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2020-04-17', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remineralization of white spot lesions', 'timeFrame': 'Evaluation of tooth surface changes at baseline and at 1, 3 and 6 months after starting treatment .', 'description': 'changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20)'}], 'secondaryOutcomes': [{'measure': 'Satisfaction of the patient: questionnaire', 'timeFrame': 'After 6 months', 'description': 'Using binary questionnaire ( Yes/No)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'descriptionModule': {'briefSummary': 'This clinical trial will be conducted to compare the efficacy of grape seed extract oil versus sodium fluoride mouth wash in the management of remineralization in adult patients with white spot lesion over six months.', 'detailedDescription': 'Natural products have long been used in traditional medicine and are promising sources for novel therapeutic agents, especially in treating oral diseases such as dental caries.\n\nPreviously, herbs are used in dentistry for prevention and curative purpose of dental caries. The main advantages of using herbal alternatives are easy availability, cost effectiveness, increased shelf life, low toxicity, and lack of microbial resistance.\n\nGrape seed extract (GSE) has been found to be a promising natural remineralizing agent for treatment of the demineralized tooth.\n\nGrape seed extract (GSE), a readily available over the counter supplement, has been noted for its potential dental restorative and caries preventative properties as a potent antioxidant. There are multiple bioactive properties in GSE, but in particular, its rich content of proanthocyanidins (PACs) plays a role in its theoretical benefit in caries prevention.\n\nPACs have hydrophobic and hydrophilic properties, which enhance their ability to irreversibly bind to a variety of compounds, particularly minerals, proteins, and carbohydrates.\n\nThe remineralization effect of GSE appears to be featured. First, it participates in mineral deposition on the superficial layer of the lesion through forming insoluble complexes and combines with calcium to enhance remineralization. Second, GSE may interact with the organic portion of enamel through PA-collagen interaction, thereby stabilizing the exposed collagen matrix.\n\nProanthocyanidin (PA) has been proved to strengthen collagen-based tissues by increasing collagen cross-links. It is claimed that it can increase collagen synthesis and accelerates the conversion of soluble collagen into insoluble collagen. Proanthocyanidin has proved safe in different clinical applications and has been used as dietary supplements as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '30 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of at least two WSLs on the labial surfaces of six maxillary anterior teeth that were not present before orthodontic therapy\n* Age range between 13 and 30years.\n\nExclusion Criteria:\n\n* Severe or active periodontal disease.\n* Patients had received therapeutic irradiation to the head and neck region.\n* Patients had participated in a clinical trial within 6 months before commencement of this trial.\n* Patients unable to return for recall appointments\n* Presence of abnormal oral, medical, or mental condition.\n* Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.'}, 'identificationModule': {'nctId': 'NCT04357093', 'briefTitle': 'Remineralizing Efficacy of Grape Seed Extract in Management of White Spot Lesion in Post Orthodontic Treated Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Remineralizing Efficacy of Grape Seed Extract Oil Versus Fluoride Mouthwash in Management of Post-Orthodontic White Spot Lesions: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Grape seed extract'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grape seed extract mouthwash', 'description': 'Grape seed extract mouth wash 15% concentration', 'interventionNames': ['Other: Grape seed extract mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sodium fluoride mouthwash', 'description': 'Sodium fluoride mouthwash 1000 ppm', 'interventionNames': ['Other: Sodium fluoride mouthwash']}], 'interventions': [{'name': 'Grape seed extract mouthwash', 'type': 'OTHER', 'otherNames': ['Grape seed extract'], 'description': 'Mouthwash 15% grape seed extract', 'armGroupLabels': ['Grape seed extract mouthwash']}, {'name': 'Sodium fluoride mouthwash', 'type': 'OTHER', 'description': 'Sodium fluoride mouthwash', 'armGroupLabels': ['Sodium fluoride mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.', 'investigatorFullName': 'Nada Abd El Sattar Mohamed Kotb', 'investigatorAffiliation': 'Cairo University'}}}}