Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-26 @ 8:35 PM
Study NCT ID:
NCT05094492
Status:
UNKNOWN
Last Update Posted:
2021-10-26
First Post:
2021-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-10-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-14', 'studyFirstSubmitDate': '2021-10-13', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remineralization', 'timeFrame': '6 months', 'description': 'measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Caries; Initial']}, 'descriptionModule': {'briefSummary': 'Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.', 'detailedDescription': 'This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active carious white spot lesions.\n* Patient compliance.\n* Controlled oral hygiene condition.\n\nExclusion Criteria:\n\n* Participant in another trial.\n* Non carious lesions.\n* Systemic diseases or concomitant medication affecting salivary flow.\n* Cavitation of carious lesions.\n* Parafunctional habits.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT05094492', 'briefTitle': 'Evaluation of Remineralization Potential of Self Assembling Peptide Combined With Fluoride', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'p11-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self assembling peptide P11-4 with fluoride', 'description': 'P11-4 forms a 3D matrix within subsurface of incipient carious lesions , allowing formation of new hydroxyapatite crystal facilitating guided regeneration of enamel lesions. Combination with fluoride will have a synergistic effect on remineralization potential', 'interventionNames': ['Combination Product: Curodont Repair Fluoride Plus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Fluoride varnish', 'description': 'Gold standard agent for remineralization of incipient carious lesions.', 'interventionNames': ['Other: Bifluorid 10 fluoride varnish']}], 'interventions': [{'name': 'Curodont Repair Fluoride Plus', 'type': 'COMBINATION_PRODUCT', 'description': 'P11-4 self assembling peptide combined with fluoride', 'armGroupLabels': ['Self assembling peptide P11-4 with fluoride']}, {'name': 'Bifluorid 10 fluoride varnish', 'type': 'OTHER', 'description': '5% Sodium Fluoride varnish (equal to 22,600 ppm fluoride)', 'armGroupLabels': ['Fluoride varnish']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'El Manial', 'country': 'Egypt', 'contacts': [{'name': 'Omar O Shaalan, Phd', 'role': 'CONTACT', 'email': 'omar.shaalan@dentistry.cu.edu.eg', 'phone': '00201122665661'}], 'facility': 'Faculty of Dentistry, Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Omar O Shaalan, PhD', 'role': 'CONTACT', 'email': 'omar.shaalan@dentistry.cu.edu.eg', 'phone': '00201122665661'}], 'overallOfficials': [{'name': 'Omar O Shaalan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Conservative Dentistry Department, Faculty of Dentistry', 'investigatorFullName': 'Omar Osama Shaalan', 'investigatorAffiliation': 'Cairo University'}}}}