Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-02-27 @ 4:31 PM
Study NCT ID:
NCT03086720
Status:
UNKNOWN
Last Update Posted:
2017-03-22
First Post:
2017-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012973', 'term': 'Sodium Hypochlorite'}, {'id': 'D014867', 'term': 'Water'}], 'ancestors': [{'id': 'D006997', 'term': 'Hypochlorous Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D006878', 'term': 'Hydroxides'}, {'id': 'D000468', 'term': 'Alkalies'}, {'id': 'D000838', 'term': 'Anions'}, {'id': 'D007477', 'term': 'Ions'}, {'id': 'D004573', 'term': 'Electrolytes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2017-03-16', 'studyFirstSubmitQcDate': '2017-03-16', 'lastUpdatePostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Retention rates of the restoration', 'timeFrame': '6, 12, 24, 36 and 60 months', 'description': 'Patients will be reevaluated at each specified time point and all restoration sites will be evaluated to check if the restoration will be still in place, or if it is missing, or if there is partial retention'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in Post-operative sensitivity', 'timeFrame': '6, 12, 24, 36 and 60 months', 'description': 'At each time-point, patients will be recalled and interviewed regarding any symptom related to each restorations placed.'}, {'measure': 'Change from baseline in marginal staining rates', 'timeFrame': '6, 12, 24, 36 and 60 months', 'description': 'At each time-point, patients will be recalled and restorations will be reassessed in order to record changes in the rates of marginal staining, using the World Dental Federation (FDI) criteria for restorations assessment (Hickel et al 2010).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adhesive system', 'Controlled clinical trial', 'Dental restoration', 'Noncarious cervical lesions', 'Dental restoration failure', 'Sodium hypochlorite'], 'conditions': ['Non-carious Cervical Lesions']}, 'referencesModule': {'references': [{'pmid': '20628774', 'type': 'BACKGROUND', 'citation': 'Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.'}, {'pmid': '28237629', 'type': 'BACKGROUND', 'citation': 'Favetti M, Schroeder T, Montagner AF, Correa MB, Pereira-Cenci T, Cenci MS. Effectiveness of pre-treatment with chlorhexidine in restoration retention: A 36-month follow-up randomized clinical trial. J Dent. 2017 May;60:44-49. doi: 10.1016/j.jdent.2017.02.014. Epub 2017 Feb 22.'}, {'pmid': '35584331', 'type': 'DERIVED', 'citation': 'Favetti M, Schroeder T, Montagner AF, Moraes RR, Pereira-Cenci T, Cenci MS. NaOCl Application after Acid Etching and Retention of Cervical Restorations: A 3-Year Randomized Clinical Trial. Oper Dent. 2022 May 1;47(3):268-278. doi: 10.2341/20-166-C.'}]}, 'descriptionModule': {'briefSummary': 'This study will verify the effect of the application of a substance (10% sodium hypoclorite -NaOCL) in dentin on noncarious cervical lesions, with the aim of increasing the longevity of the restorations performed in this type of lesion.\n\nThe hypothesis of the present study is that the application of deproteinization solution after acid etching does not influence the failure rate of the restorations.', 'detailedDescription': 'The purpose of this study will be to evaluate the failure rates of composite restorations of non-carious cervical lesions (NCCL) performed with or without the pre-treatment with 10% sodium hypochlorite (NaOCl) on etched dentin.\n\nA randomized controlled split-mouth and double blind clinical trial will be carried out. Patients with at least two NCCL will be selected. Each patient will be received at least one pair of composite restorations (Filtek Z350/3M ESPE), bonded either with 2 techniques: control (acid etching + placebo solution for 60 seconds + Adper Single Bond 2/3M ESPE) or experimental (acid etching + 10% NaOCl for 60 seconds + Adper Single Bond 2). A calibrated examiner will be evaluated the restorations (baseline, 6-, 12-, 24- and 36-month) using the FDI criteria. The primary outcome is retention of the restoration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients presenting at least two non-carious cervical lesions (NCL) in anterior, canine or pre-molars;\n* Patients who had more than 20 teeth in the mouth;\n* Patients who were at least 18 years of age at the time of treatment and capable to understand and sign the written informed consent;\n* NCL in the facial surface of the teeth with sometimes a small part extending interproximally; Patients with good periodontal heath.\n\nExclusion Criteria:\n\n* Patients with smoking habits, practicing bruxism, severe systemic diseases, using active orthodontic treatment, malocclusion (Angle Class II or Class III);\n* Tooth with the NCL with the absent of antagonist;\n* NCL wear facets upper than 50% of the incisal/occlusion surface, as a result of tooth attrition;\n* Presence of caries or restorations in the area to be treated;\n* Full-mouth visible plaque index (VPI) or full-mouth gingival bleeding index upper than 20%, probing depth and clinical attachment loss values exceeding 4 mm with bleeding on probing;\n* Unwillingness to return for follow-ups or refuse to participate.'}, 'identificationModule': {'nctId': 'NCT03086720', 'briefTitle': 'Deproteinization as a Coadjuvant in Dentin Adhesion of Noncarious Cervical Lesions', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Pelotas'}, 'officialTitle': 'Effect of Sodium Hypochlorite Pre-treatment on the Retention of Restorations for Non-carious Cervical Lesions: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'UFPEL- PPGO 0019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sodium hypochlorite', 'description': 'Dentin pre-treatment with a experimental solution (sodium hupochlorite), after the dentin acid etching', 'interventionNames': ['Procedure: Sodium hypochlorite']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Water', 'description': 'Application of water (placebo) after dentin acid etching', 'interventionNames': ['Procedure: Water']}], 'interventions': [{'name': 'Sodium hypochlorite', 'type': 'PROCEDURE', 'description': 'Application of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system.', 'armGroupLabels': ['Sodium hypochlorite']}, {'name': 'Water', 'type': 'PROCEDURE', 'description': 'Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application', 'armGroupLabels': ['Water']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96015560', 'city': 'Pelotas', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Federal University of Pelotas - School of Dentistry', 'geoPoint': {'lat': -31.76997, 'lon': -52.34101}}], 'overallOfficials': [{'name': 'Maximiliano Cenci, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Dentistry, Federal University of Pelotas'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Pelotas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Maximiliano Sergio Cenci', 'investigatorAffiliation': 'Federal University of Pelotas'}}}}