Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-26 @ 12:48 AM
Study NCT ID:
NCT02724592
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2016-03-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alkilzym@uni-greifswald.de', 'phone': '0049-17623399340', 'title': 'Dr. Mohammad Alkilzy', 'organization': 'University of Greifswald'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'description': 'Incidence of Treatment-Emergent Adverse Events (definitions are adapted from Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42). Safety definitions are adapted from the Directive 2001/20/EC and in accordance with ISO 14155 and MDD 93/42.', 'eventGroups': [{'id': 'EG000', 'title': 'Intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)\n\nself assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'control group, only Fluoride varnish (Duraphat®)\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)\n\nself assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'control group, only Fluoride varnish (Duraphat®)\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'spread': '19.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '25.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device.\n\nDiagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity.\n\nEffect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Visual Analog Scale of Lesion Progression (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)\n\nself assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'control group, only Fluoride varnish (Duraphat®)\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '88.0', 'spread': '40.8', 'groupId': 'OG000'}, {'value': '49.1', 'spread': '43.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'Visual Analog Scale of lesion progression (VAS), Effect via t test between Baseline and 6-months recall VAS values range from -100 % to +100 %. The value of -100 means that the carious lesion is strongly remineralising, the value of 0 means that the lesion is arrested, and the value of +100 means that the lesion is strongly progressing.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICDAS Classification Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)\n\nself assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'control group, only Fluoride varnish (Duraphat®)\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Number of patients who have improvement on the ICDAS classification index (International Caries Detection and Assessment System), changes from Baseline to 6-months recall.\n\nThis carries clinical index range from 0 to 6. The values mean:\n\n0 No evidence of caries\n\n1. Initial caries\n2. Distinct visual change in enamel\n3. Localised enamel breakdown due to caries with no visible dentine\n4. Underlying dark shadow from dentine\n5. Distinct cavity with visible dentine\n6. Extensive distinct cavity with visible dentine. During the study, a change from level to lower level number (e.g. from 2 to 1) in patients means that the carious lesion is regressed.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Caries Activity Assessment According to Nyvad Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)\n\nself assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}, {'id': 'OG001', 'title': 'Control', 'description': 'control group, only Fluoride varnish (Duraphat®)\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'description': 'Caries activity assessment according to Nyvad criteria, number of participants still have active lesions overall study.\n\nThis assessment includes two clinical judgment inserts: active lesion or inactive lesion basing on visual-tactile surface characteristics of the caries lesions such as integrity, texture, translucency/opacity, lesion location, and surface color.\n\nDuring the study, an alteration from active lesion to in active lesion means an improvement.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)\n\nself assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}, {'id': 'FG001', 'title': 'Control', 'description': 'control group, only Fluoride varnish (Duraphat®)\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '70 patients met the inclusion criteria and offered participation', 'preAssignmentDetails': 'No patient declined to participate'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)\n\nself assembling peptide P11-4 (Curodont™ Repair): Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}, {'id': 'BG001', 'title': 'Control', 'description': 'control group, only Fluoride varnish (Duraphat®)\n\nfluoride varnish (Duraphat®): Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '9.0', 'groupId': 'BG000', 'lowerLimit': '7.0', 'upperLimit': '13.0'}, {'value': '10.5', 'groupId': 'BG001', 'lowerLimit': '8.0', 'upperLimit': '13.0'}, {'value': '9.75', 'groupId': 'BG002', 'lowerLimit': '7.0', 'upperLimit': '13.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Germany', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-15', 'studyFirstSubmitDate': '2016-03-07', 'resultsFirstSubmitDate': '2017-02-27', 'studyFirstSubmitQcDate': '2016-03-24', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-15', 'studyFirstPostDateStruct': {'date': '2016-03-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Caries Activity and Progression Assessment Using LASER Fluorescence Readings by Diagnodent® Device.', 'timeFrame': '6 months', 'description': 'Evaluation of the additional therapeutic benefit of Curodont™ compared to fluoride varnish (Duraphat®) alone on early occlusal carious lesions using LASER "Light Amplification by Stimulated Emission of Radiation" fluorescence readings by Diagnodent® device.\n\nDiagnodent® device measures the caries activity using LASER fluorescence of bacterial secretions in the caries lesion. The readings range from 0 to 99; 0 means no bacterial activity in the carious lesion whereas 99 refers to high bacterial and caries activity.\n\nEffect via the changes in LASER fluorescence readings between Baseline and 6-months recall (Change = Baseline value - 6 months value). Higher positive change value means caries regression, whereas lower positive or negative change value refers to caries progression.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog Scale of Lesion Progression (VAS)', 'timeFrame': '6 months', 'description': 'Visual Analog Scale of lesion progression (VAS), Effect via t test between Baseline and 6-months recall VAS values range from -100 % to +100 %. The value of -100 means that the carious lesion is strongly remineralising, the value of 0 means that the lesion is arrested, and the value of +100 means that the lesion is strongly progressing.'}, {'measure': 'ICDAS Classification Index', 'timeFrame': '6 months', 'description': 'Number of patients who have improvement on the ICDAS classification index (International Caries Detection and Assessment System), changes from Baseline to 6-months recall.\n\nThis carries clinical index range from 0 to 6. The values mean:\n\n0 No evidence of caries\n\n1. Initial caries\n2. Distinct visual change in enamel\n3. Localised enamel breakdown due to caries with no visible dentine\n4. Underlying dark shadow from dentine\n5. Distinct cavity with visible dentine\n6. Extensive distinct cavity with visible dentine. During the study, a change from level to lower level number (e.g. from 2 to 1) in patients means that the carious lesion is regressed.'}, {'measure': 'Caries Activity Assessment According to Nyvad Criteria', 'timeFrame': '6 months', 'description': 'Caries activity assessment according to Nyvad criteria, number of participants still have active lesions overall study.\n\nThis assessment includes two clinical judgment inserts: active lesion or inactive lesion basing on visual-tactile surface characteristics of the caries lesions such as integrity, texture, translucency/opacity, lesion location, and surface color.\n\nDuring the study, an alteration from active lesion to in active lesion means an improvement.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dental Caries']}, 'referencesModule': {'references': [{'pmid': '28892645', 'type': 'DERIVED', 'citation': 'Alkilzy M, Tarabaih A, Santamaria RM, Splieth CH. Self-assembling Peptide P11-4 and Fluoride for Regenerating Enamel. J Dent Res. 2018 Feb;97(2):148-154. doi: 10.1177/0022034517730531. Epub 2017 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'Objectives: Occlusal surfaces of erupting permanent molars are highly prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.\n\nMethods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups.', 'detailedDescription': "Objectives: Occlusal surfaces of erupting permanent molars are high prone to caries. Self-assembling peptide (P11-4) has proven to enhance biomimetic mineralization of early carious lesions. Aim of this study was to evaluate safety, clinical applicability and effect of using P11-4 (Curodont™ Repair) in non-invasive treatment of early occlusal lesions.\n\nMethods: 70 patients with active early occlusal lesions (ICDAS-II:1-3) on first or second permanent molars at eruption will be allocated in this randomized, controlled, single blinded study to test (Curodont™ Repair+Duraphat®) or control (Duraphat®) groups. Safety and applicability will be evaluated using dentist's/patient's questionnaires about adverse events, difficulties of application and satisfaction with procedure. Lesions will be assessed at baseline and recalls after 3 and 6 months regarding caries activity, clinical status (ICDAS-II) and with Diagnodent®. The Visual Analog Scale (VAS) of regression and of lesion size in addition to the Global Impression of Change Questionnaire will also be assessed. At every recall, fluoride varnish will be applied on lesions and patients received oral health instructions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Early occlusal carious lesions (without cavity) on permanent molar "6" or "7" at eruption which does not require an invasive treatment\n* Age ≥ 5 years\n* Size and form of the lesions: the lesions must both be fully visible and assessable and accessible\n* Willing and able to attend the on-study visits and to observe good oral hygiene throughout the study\n* Written informed consent before participation in the study\n\nExclusion Criteria:\n\n* Evidence of tooth erosion\n* Fluoride varnish application \\< 3 months prior to study treatment\n* History of head and neck illnesses (e.g. head/neck cancer)\n* Any pathology or concomitant medication affecting salivary flow or dry mouth\n* Any metabolic disorders affecting bone turnover\n* Concurrent participation in another clinical trial'}, 'identificationModule': {'nctId': 'NCT02724592', 'briefTitle': 'Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Effect of Self Assembling Peptide P11-4 in Patients With Early Occlusal Carious Lesions: A Mono-centre, Controlled, Single-blinded, Randomised Study', 'orgStudyIdInfo': {'id': 'BB001/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention', 'description': 'intervention group, self assembling peptide P11-4 (Curodont™ Repair) and fluoride varnish (Duraphat®)', 'interventionNames': ['Device: self assembling peptide P11-4 (Curodont™ Repair)', 'Device: fluoride varnish (Duraphat®)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'control group, only Fluoride varnish (Duraphat®)', 'interventionNames': ['Device: fluoride varnish (Duraphat®)']}], 'interventions': [{'name': 'self assembling peptide P11-4 (Curodont™ Repair)', 'type': 'DEVICE', 'description': 'Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions', 'armGroupLabels': ['intervention']}, {'name': 'fluoride varnish (Duraphat®)', 'type': 'DEVICE', 'description': 'Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions', 'armGroupLabels': ['control', 'intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mohammad Alkilzy, Dr. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Greifswald'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}