Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-02-22 @ 6:45 PM
Study NCT ID:
NCT02419157
Status:
COMPLETED
Last Update Posted:
2015-04-17
First Post:
2015-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Selective Enamel Etching in Self-etching Adhesives: a 2-year Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C030242', 'term': 'phosphoric acid'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-16', 'studyFirstSubmitDate': '2015-03-29', 'studyFirstSubmitQcDate': '2015-04-16', 'lastUpdatePostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Restoration retention rate as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months', 'timeFrame': 'Baseline, 3, 6, 12, 18 and 24 months'}], 'secondaryOutcomes': [{'measure': 'Restoration marginal integrity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months', 'timeFrame': 'Baseline, 3, 6, 12, 18 and 24 months'}, {'measure': 'Restoration marginal staining as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months', 'timeFrame': 'Baseline, 3, 6, 12, 18 and 24 months'}, {'measure': 'Secondary caries as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months', 'timeFrame': 'Baseline, 3, 6, 12, 18 and 24 months'}, {'measure': 'Post-operative sensitivity as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months', 'timeFrame': 'Baseline, 3, 6, 12, 18 and 24 months'}, {'measure': 'Pulp vitality as measured by modified U.S. Public Health Service evaluation criteria at baseline, 3, 6, 12, 18 and 24 months', 'timeFrame': 'Baseline, 3, 6, 12, 18 and 24 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cervical lesions', 'Clinical trial', 'Self-etch adhesive'], 'conditions': ['Selective Enamel Etching in Dental Restorations']}, 'referencesModule': {'references': [{'pmid': '15668328', 'type': 'BACKGROUND', 'citation': 'De Munck J, Van Landuyt K, Peumans M, Poitevin A, Lambrechts P, Braem M, Van Meerbeek B. A critical review of the durability of adhesion to tooth tissue: methods and results. J Dent Res. 2005 Feb;84(2):118-32. doi: 10.1177/154405910508400204.'}, {'pmid': '15765956', 'type': 'BACKGROUND', 'citation': 'De Munck J, Vargas M, Iracki J, Van Landuyt K, Poitevin A, Lambrechts P, Van Meerbeek B. One-day bonding effectiveness of new self-etch adhesives to bur-cut enamel and dentin. Oper Dent. 2005 Jan-Feb;30(1):39-49.'}, {'pmid': '12638771', 'type': 'BACKGROUND', 'citation': 'Perdigao J, Geraldeli S. Bonding characteristics of self-etching adhesives to intact versus prepared enamel. J Esthet Restor Dent. 2003;15(1):32-41; discussion 42. doi: 10.1111/j.1708-8240.2003.tb00280.x.'}, {'pmid': '17432395', 'type': 'BACKGROUND', 'citation': 'Peumans M, De Munck J, Van Landuyt K, Lambrechts P, Van Meerbeek B. Five-year clinical effectiveness of a two-step self-etching adhesive. J Adhes Dent. 2007 Feb;9(1):7-10.'}, {'pmid': '15766585', 'type': 'BACKGROUND', 'citation': 'Van Meerbeek B, Kanumilli P, De Munck J, Van Landuyt K, Lambrechts P, Peumans M. A randomized controlled study evaluating the effectiveness of a two-step self-etch adhesive with and without selective phosphoric-acid etching of enamel. Dent Mater. 2005 Apr;21(4):375-83. doi: 10.1016/j.dental.2004.05.008.'}, {'pmid': '17302950', 'type': 'BACKGROUND', 'citation': 'Reis AF, Bedran-Russo AK, Giannini M, Pereira PN. Interfacial ultramorphology of single-step adhesives: nanoleakage as a function of time. J Oral Rehabil. 2007 Mar;34(3):213-21. doi: 10.1111/j.1365-2842.2006.01656.x.'}, {'pmid': '16315023', 'type': 'BACKGROUND', 'citation': 'Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems applied with or without selective enamel etching.', 'detailedDescription': 'The purpose of this study is to evaluate the clinical effectiveness of non-carious cervical lesions (NCCLs) restored with two self-etching adhesive systems: Clearfil SE Bond (Kuraray Noritake, Japan) and Xeno V + (Dentsply De Trey, Germany) applied with or without 36% phosphoric acid enamel etching. Assessments were at baseline, 3, 6, 12, 18 and 24 months of clinical service.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be at least 18 years;\n* Present at least 4 NCCLs in vital teeth with margins in enamel and dentin (and its largest area in dentin), independently of teeth location;\n* Non-smoking;\n* Read and sign the Statement of Informed Consent.\n\nExclusion Criteria:\n\n* Compromised medical history;\n* Severe or chronic periodontitis;\n* Extreme caries sensitivity;\n* Heavy bruxism;\n* Under orthodontic treatment;\n* Poor oral hygiene;\n* Smokers.'}, 'identificationModule': {'nctId': 'NCT02419157', 'briefTitle': 'Selective Enamel Etching in Self-etching Adhesives: a 2-year Clinical Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Guarulhos'}, 'officialTitle': 'Effectiveness of One- and Two-step Self-etching Adhesives Applied With or Without Selective Enamel Etching: a 2-year Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'PRGRE 2015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Clearfil SE Bond Etch (CSE-E)', 'description': "CSE-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points.\n\nSelective enamel etching with 36% phosphoric acid", 'interventionNames': ['Drug: Selective enamel etching with 36% phosphoric acid', 'Device: Clearfil SE Bond']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xeno V+ Etch (XV-E)', 'description': "XV-E (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Enamel margins were selectively etched with 36% phosphoric acid for 15s and subsequently thoroughly rinsed and air-dried. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points.\n\nSelective enamel etching with 36% phosphoric acid", 'interventionNames': ['Drug: Selective enamel etching with 36% phosphoric acid', 'Device: Xeno V']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Clearfil SE Bon Non-etch (CSE-NE)', 'description': "CSE-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points.\n\nNo selective enamel etching with 36% phosphoric acid", 'interventionNames': ['Drug: No selective enamel etching with 36% phosphoric acid', 'Device: Clearfil SE Bond']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Xeno V+ Non-etch (XV-NE)', 'description': "XV-NE (n=28): After shade selection, teeth were restored under relative isolation. Lesions were cleaned with pumice and water in a rubber cup followed by rinsing and drying. An enamel bevel of 1-2 mm was prepared with a diamond bur operated in a high-speed handpiece under air-water spray. Adhesive system was applied according to manufacturers' instructions and light-cured with an LED for 10s. NCCLs were restored incrementally with a microhybrid composite resin. Increments were light cured for 20s. Afterwards, retraction cord was removed and finishing and polishing were performed with rubber points.\n\nNo selective enamel etching with 36% phosphoric acid", 'interventionNames': ['Drug: No selective enamel etching with 36% phosphoric acid', 'Device: Xeno V']}], 'interventions': [{'name': 'Selective enamel etching with 36% phosphoric acid', 'type': 'DRUG', 'otherNames': ['36% phosphoric acid'], 'description': 'Etch: selective 36% phosphoric acid enamel etching', 'armGroupLabels': ['Clearfil SE Bond Etch (CSE-E)', 'Xeno V+ Etch (XV-E)']}, {'name': 'No selective enamel etching with 36% phosphoric acid', 'type': 'DRUG', 'otherNames': ['Without 36% phosphoric acid'], 'description': 'Non-etch: without phosphoric acid selective enamel etching', 'armGroupLabels': ['Clearfil SE Bon Non-etch (CSE-NE)', 'Xeno V+ Non-etch (XV-NE)']}, {'name': 'Clearfil SE Bond', 'type': 'DEVICE', 'armGroupLabels': ['Clearfil SE Bon Non-etch (CSE-NE)', 'Clearfil SE Bond Etch (CSE-E)']}, {'name': 'Xeno V', 'type': 'DEVICE', 'armGroupLabels': ['Xeno V+ Etch (XV-E)', 'Xeno V+ Non-etch (XV-NE)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'André F Reis', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Guarulhos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guarulhos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Faculty', 'investigatorFullName': 'Caroline Ely', 'investigatorAffiliation': 'University of Guarulhos'}}}}