Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-28 @ 6:49 AM
Study NCT ID:
NCT07034235
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2025-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Wet and Overwet Dentin on the Clinical Performance of Two Universal Adhesive Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014077', 'term': 'Tooth Erosion'}, {'id': 'D057085', 'term': 'Tooth Wear'}], 'ancestors': [{'id': 'D017001', 'term': 'Tooth Demineralization'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Two blinded, experienced, and calibrated dentists (who specialized in esthetic dentistry with more than 15 years of clinical practice), will perform the clinical evaluation. Patients will be also blinded to group assignment. An inter-examiner and inter-examiner agreement of at least 85% will be necessary before beginning the evaluation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a four-arm, double-blind, randomized controlled clinical trial. Control group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on wet dentin in the etch-and-rinse application strategy.\n\nControl group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime\\&Bond Active; Dentsply Sirona) on wet dentin in the etch-and-rinse application strategy.\n\nExperimental group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on overwet dentin in the etch-and-rinse application strategy.\n\nExperimental group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime\\&Bond Active; Dentsply Sirona) on overwet dentin in the etch-and-rinse application strategy'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-01-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-13', 'studyFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2025-06-13', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retention of restorations', 'timeFrame': 'From date of randomization until thirty-six four months', 'description': 'Retention measured by World Dental Federation (FDI) criteria as following:\n\n* VG: Clinically very good - Restoration retained, no fractures / cracks;\n* G: Clinically good - Small hairline crack;\n* SS: Clinically sufficient/satisfactory - Two or more or larger hairline cracks and/or chipping (not affecting the marginal integrity);\n* US: Clinically unsatisfactory - Chipping fractures which damage marginal quality; bulk fractures with or without partial loss (less than half of the restoration);\n* PO: Clinically poor - (Partial or complete) loss of restoration, (replacement necessary).'}], 'secondaryOutcomes': [{'measure': 'Marginal Adaptation of restorations', 'timeFrame': 'From date of randomization until thirty six months', 'description': 'Marginal Adaptation measured by World Dental Federation (FDI) criteria as following:\n\n* VG: Clinically very good - Harmonious outline, no gaps, no discoloration;\n* G: Clinically good - Small marginal fracture removable by polishing;\n* SS: Clinically sufficient/satisfactory - Several small enamel or dentin fractures;\n* US: Clinically unsatisfactory - Notable enamel or dentine wall fracture;\n* PO: Clinically poor - Filling is loose but in situ.'}, {'measure': 'Marginal Staining of restorations', 'timeFrame': 'From date of randomization until thirty six months', 'description': 'Marginal Staining measured by World Dental Federation (FDI) criteria as following:\n\n* VG: Clinically very good - No marginal staining;\n* G: Clinically good - Minor marginal staining, easily removable by polishing;\n* SS: Clinically sufficient/satisfactory - Moderate marginal staining, not esthetically unacceptable;\n* US: Clinically unsatisfactory - Pronounced marginal staining; major intervention necessary for improvement;\n* PO: Clinically poor - Deep marginal staining not accessible for intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dental bonding', 'Tooth erosion', 'Tooth Wear', 'Adhesive systems', 'Dentinal moisture'], 'conditions': ['Non-carious Cervical Lesions']}, 'descriptionModule': {'briefSummary': 'The aim of this study will be to evaluate the effect of wet and overwet dentin on the long-term clinical performance of two universal adhesive systems used as etch-and-rinse application mode in non-carious cervical lesions (NCCLs).\n\nMaterials \\& Methods: 200 restorations will be randomly placed in 50 subjects according to the following groups (n=50): AMP-wet (Ambar Universal APS Plus adhesive on wet dentin); AMP-overwet (Ambar Universal APS Plus adhesive on oversaturated dentin); PBA-wet (Prime\\&Bond Active adhesive on wet dentin); PBA-overwet (Prime\\&Bond Active adhesive on oversaturated dentin). For all groups, the enamel and dentin will be etched for 15s. All groups will be light-cured for 10s/1,000 mW/cm2. A resin composite will be placed by applying three increments and each one was light cured for 20s/1,000 mW/cm2. The restorations will be finished immediately with fine diamond burs and spiral polishers. The restorations will be evaluated at baseline and after 6 months by using the FDI criteria. The following outcomes will be evaluated: retention, marginal staining, marginal adaptation, post-operative sensitivity and recurrence of caries. The differences among the groups will be calculated using Friedman repeated measures analysis of variance rank (α = 0.05).', 'detailedDescription': 'This is a four-arm, double-blind, randomized controlled clinical trial.\n\nControl group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on wet dentin in the etch-and-rinse application strategy.\n\nControl group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime\\&Bond Active; Dentsply Sirona) on wet dentin in the etch-and-rinse application strategy.\n\nExperimental group 1: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Ambar Universal APS Plus; FGM) on overwet dentin in the etch-and-rinse application strategy.\n\nExperimental group 2: 50 non-carious cervical lesions (NCCL) will receive composite resin restorations using an universal adhesive (Prime\\&Bond Active; Dentsply Sirona) on overwet dentin in the etch-and-rinse application strategy\n\nLCNCs will be randomized to universal adhesive usage and dentinal moisture levels. All groups will be light-cured with a lightcuring device (Quazar, FGM) with a light intensity of 900 mW/cm² for 10 seconds. Operators will restore the cervical area by applying three increments of resin (Llis-FGM for experimental groups 1 and 2; and TPH Spectrum-Dentsply for experimental groups 3 and 4). Each increment will light cure for 20 s at 900 mW/cm2 (Quazar, FGM). Restorations will be finished immediately with fine and extra fine diamond burs and polished with polishing spirals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients older than 18 years.\n* Presence of at least two Non-Carious Cervical Lesions in the dental arch with a need for restorative treatment.\n* Acceptable level of oral hygiene according to the Simplified Oral Hygiene Index.\n* At least 20 teeth in function.\n\nExclusion Criteria:\n\n* Driving difficulties that prevent adequate oral hygiene.\n* Periodontal disease.\n* Active caries lesions on the teeth included in the research.\n* Parafunctional habits.\n* Active staples of removable partial dentures on the teeth included in the research and that these are not pillars of prostheses.'}, 'identificationModule': {'nctId': 'NCT07034235', 'briefTitle': 'Effect of Wet and Overwet Dentin on the Clinical Performance of Two Universal Adhesive Systems', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de los Andes, Chile'}, 'officialTitle': 'Clinical Evaluation of the Effect of Wet and Overwet Dentin Using Two Universal Adhesives in Restorations of Non-carious Cervical Lesions: Double Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'F142025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group 1', 'description': '50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.', 'interventionNames': ['Procedure: Dentin Overwet', 'Device: Ambar Universal APS Plus; FGM']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group 2', 'description': '50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.', 'interventionNames': ['Procedure: Dentin Overwet', 'Device: Prime&Bond Active; Dentsply Sirona']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group 1', 'description': '50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.', 'interventionNames': ['Procedure: Dentin Wet', 'Device: Ambar Universal APS Plus; FGM']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group 2', 'description': '50 non-carious cervical lesions (NCCL) will receive composite resin restorations in the etch-and-rinse strategy.', 'interventionNames': ['Procedure: Dentin Wet', 'Device: Prime&Bond Active; Dentsply Sirona']}], 'interventions': [{'name': 'Dentin Wet', 'type': 'PROCEDURE', 'description': 'Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on wet dentin in the etch-and-rinse application strategy.', 'armGroupLabels': ['Control group 1', 'Control group 2']}, {'name': 'Dentin Overwet', 'type': 'PROCEDURE', 'description': 'Composite resin restorations of non-carious cervical lesions will be performed with an adhesive on overwet dentin in the etch-and-rinse application strategy.', 'armGroupLabels': ['Experimental group 1', 'Experimental group 2']}, {'name': 'Ambar Universal APS Plus; FGM', 'type': 'DEVICE', 'description': 'Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive', 'armGroupLabels': ['Control group 1', 'Experimental group 1']}, {'name': 'Prime&Bond Active; Dentsply Sirona', 'type': 'DEVICE', 'description': 'Composite resin restorations of non-carious cervical lesions will be performed with an universal adhesive', 'armGroupLabels': ['Control group 2', 'Experimental group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8360053', 'city': 'Santiago', 'state': 'Santiago Metropolitan', 'country': 'Chile', 'facility': 'Mario Felipe Gutiérrez Reyes', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}], 'overallOfficials': [{'name': 'Mario Gutierrez, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidad de los Andes, Chile'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de los Andes, Chile', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade Estadual de Ponta Grossa', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Mario Felipe Gutiérrez Reyes', 'investigatorAffiliation': 'Universidad de los Andes, Chile'}}}}