Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT07065305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-29
First Post:
2025-06-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005459', 'term': 'Fluorides'}, {'id': 'D017438', 'term': 'Bisphenol A-Glycidyl Methacrylate'}, {'id': 'C020946', 'term': 'triethylene glycol dimethacrylate'}], 'ancestors': [{'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D006858', 'term': 'Hydrofluoric Acid'}, {'id': 'D017611', 'term': 'Fluorine Compounds'}, {'id': 'D008689', 'term': 'Methacrylates'}, {'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000098826', 'term': 'Bisphenol A Compounds'}, {'id': 'D000098704', 'term': 'Bisphenols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D003188', 'term': 'Composite Resins'}, {'id': 'D012117', 'term': 'Resins, Synthetic'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '* Eligible patients will be randomly assigned to the intervention or control group using computer-generated random numbers.\n* Allocation concealment will be ensured using sealed opaque envelopes.\n* Clinical evaluators assessing outcomes will be blinded to the group allocation to reduce bias.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '* Group 1 no pretreatment will received.\n* Group 2 will receive Curodont Repair (P11-4 plus fluoride).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 21}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-24', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-07-03', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Marginal integrity of restorations', 'timeFrame': '6 months and 12 months', 'description': 'Assessed using mirror and probe according to Modified USPHS Criteria'}, {'measure': 'Clinical longevity of restorations', 'timeFrame': '6 and 12 months', 'description': 'Assessed by restoration retention using mirror and probe'}, {'measure': 'Overall clinical performance of restorations', 'timeFrame': '6 and 12 months', 'description': 'Evaluated using Modified USPHS Criteria'}], 'secondaryOutcomes': [{'measure': 'Postoperative hypersensitivity', 'timeFrame': '6 and 12 months', 'description': 'Evaluated using cold spray test'}, {'measure': 'Marginal discoloration', 'timeFrame': '6 and 12 months', 'description': 'Assessed using digital photographic method'}, {'measure': 'Recurrent caries', 'timeFrame': '6 and 12 months', 'description': 'Detected using digital photographic method'}, {'measure': 'Surface roughness', 'timeFrame': '6 and 12 months', 'description': 'Evaluated using digital photographic method'}, {'measure': 'Surface luster', 'timeFrame': '6 and 12 months', 'description': 'Assessed using digital photographic method'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Er, Cr: YSGG Laser', 'Caries-Affected Dentin', 'Remineralization Potential', 'Self-Assembling Peptide P11-4 Containing Fluoride'], 'conditions': ['Remineralization Potential', 'Dentin Caries']}, 'descriptionModule': {'briefSummary': 'This study will be performed in two parts, in vivo and in vitro to assess the effect of the remineralization potential of self-assembling peptide P11-4 containing Fluoride on caries-affected dentin compared to untreated caries-affected dentin and the influence of Er, Cr: YSGG Laser treatment.', 'detailedDescription': 'The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride treatment applied over demineralized dentin in occlusal carious molars.\n\n* Research objectives: To assess the effect of the two treatment modalities to enhance remineralization of demineralized dentin and clinical performance of restorations.\n* Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance the remineralization and clinical performance of composite restorations In Vitro Study\n\n 1- The present study will be performed to evaluate the remineralization potential of the self-assembling peptide P11-4 combined with fluoride and its effect on bond strength and analyze morphological changes over demineralized dentin in occlusal carious molars using Scanning Electron Microscopy (SEM).\n* Research Objectives: To evaluate the effect of Curodont Repair Fluoride Plus and Er,Cr:YSGG laser pretreatment on the bond strength of composite resin to superficial and deep dentin.\n* Research question: Will pretreatment of caries affected dentin using self-assembling peptide P11-4 containing fluoride compared to untreated caries-affected dentin will enhance bond strength?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* o Patients aged (20 - 40) years.\n\n * Presence of at least one posterior permanent molar with an occlusal carious lesion classified as ICDAS code 3 or 4 requiring operative treatment.\n * Good general and oral health.\n * Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n* o Patients with systemic conditions affecting oral health or healing.\n\n * Teeth with pulp involvement or periapical pathology.\n * Allergy to study materials.\n * Poor oral hygiene or periodontal disease in the target tooth region.'}, 'identificationModule': {'nctId': 'NCT07065305', 'briefTitle': 'Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions', 'orgStudyIdInfo': {'id': 'OPDEN-103-1-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Curodont Repair Fluoride Plus (P11-4 + fluoride)', 'description': "• In the Intervention group the Curodont Repair (P11-4 + fluoride) will be applied according to the manufacturer's instructions: The paste is gently applied to the dentin surface and left undisturbed for 5 minutes to allow self-assembly and infiltration and excess material will be removed with a gentle air spray", 'interventionNames': ['Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland', 'Drug: Beautifil II LS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Beautifil II LS', 'description': 'No pretreatment; proceed directly to bonding. Then the surface will dry with absorbent paper. A layer of the adhesive system (BeautiBond extrem, Shofu Inc., Kyoto, Japan) will be actively applied for 20 seconds using a micro brush. Then, the adhesive will light-cure for 10 seconds with Radii-cal LED light curing device (1200 mW/cm2) (SDI, Bayswater, Australia) (2', 'interventionNames': ['Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland', 'Drug: Beautifil II LS']}], 'interventions': [{'name': 'Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland', 'type': 'DRUG', 'description': 'Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)', 'armGroupLabels': ['Beautifil II LS', 'Curodont Repair Fluoride Plus (P11-4 + fluoride)']}, {'name': 'Beautifil II LS', 'type': 'DRUG', 'otherNames': ['S-PRG (Surface Pre-Reacted Glass-ionomer) filler, Bis-GMA, TEGDMA, glass fillers , Shofu Inc., Kyoto, Japan', 'Giomer-based restorative composite'], 'description': 'Application of Giomer restorative material following standard adhesive procedures without pretreatment.', 'armGroupLabels': ['Beautifil II LS', 'Curodont Repair Fluoride Plus (P11-4 + fluoride)']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of Restorative Dentistry', 'investigatorFullName': 'Fatheya Mansour Elshinawy', 'investigatorAffiliation': 'Misr University for Science and Technology'}}}}