protocolSection identificationModule nctId: NCT06275581, orgStudyIdInfo id: CR15_15 (EM-11-050055), briefTitle: Clinical Evaluation of the Performance of a Newly Developed Glass Ionomer Restorative for Posterior Restorations in an Adult Population, statusModule overallStatus: TERMINATED, startDateStruct date: 2017-06-14, primaryCompletionDateStruct date: 2021-03-24, completionDateStruct date: 2021-10-01, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: Universidad Europea de Madrid, class: OTHER, collaborators name: 3M, descriptionModule briefSummary: STUDY DESIGN Post market clinical follow-up; pilot study, prospective, controlled, randomized, split-mouth, blinded evaluation INTRODUCTION AND PURPOSE OF STUDY Continuous advancements in the field of glass ionomers have led to an increasing range of permanent indications, especially with regards to stress bearing Class II restorations. As a further development in the 3M glass ionomer category, Ketac Universal can be used for the abovementioned indication in a simplified procedure without the need for cavity conditioning or restoration coating. All products used in this study are CE marked thus can be used for routine clinical treatment.STUDY OBJECTIVES Objective of the study is to evaluate the clinical survival and quality parameters of Class II Ketac Universal restorations compared to intra-individual (split-mouth) Class II Ketac Molar Quick control restorations over time STUDY ENDPOINTSPrimary Endpoint:1. Evaluation of restoration survival over time based on the glass ionomer restoration criteria (simplified FDI criteria as proposed by Mathilde Peters et al.)Secondary Endpoints:1. Evaluation of restoration quality based on the glass ionomer restoration criteria (simplified FDI criteria)2. Evaluation of restoration wear based on comparison of digital impressionsSafety Endpoint:1. Evaluation of potential adverse events NULL HYPOTHESIS There is no statistically significant difference between both glass ionomers* regarding overall survival* regarding restoration quality parameters TEST GROUP Ketac Universal Aplicap Glass Ionomer Restorative (3M) CONTROL GROUP Ketac Molar Quick Aplicap Glass Ionomer Restorative (3M)* regarding restoration wear METHODS AND MATERIALS A total of 39 subjects were enrolled and treated. The study was originally planned with 80 patients. Due to slow recruitment, it was decided to decrease the number of patients.Treatment:After signing informed consent, test and control product were randomly assigned to the two study teeth (randomization letter). Restoration extension (e.g. mod) and reason for restoration placement (e.g. secondary caries, tooth fracture) were recorded in the CRF. Two teeth per subject were included. Each product was used strictly according to respective Instructions for Use without using the optional protective coating. Restorations were placed in combination with sectional matrix system (Palodent system) and according to best practice (especially with regards to moisture control). Finishing and polishing was done with the Sof-Lex system. Areas in close proximity to the pulp were covered with local application of a calcium hydroxide material in both study materials. Study teeth were excluded from study if pulp exposure had occurred or if only a repair restoration was required instead of a full Class II restoration.Evaluation periods:All subjects were evaluated by two independent evaluators according to Performance Criteria for Posterior Glass Ionomer Restorations (simplified FDI criteria)* at baseline at day of restoration placement or up to 1 month after restoration placement* after 6 months (± 1 months)* after 1 year (± 1 months)* after 2 years (± 1 months) In addition, photos (at least occlusal view) were taken of every study tooth prior to restoration placement and at every evaluation.In order to further assess the wear of both restorative materials, full arch digital impressions (both upper and lower jaw) were taken at baseline evaluation and at every following evaluation using 3M True Definition Scanner. STL files were digitally compared to those taken at baseline., conditionsModule conditions: Tooth Wear, conditions: Glass Ionomer Cements, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Blinded evaluation, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 39, type: ACTUAL, armsInterventionsModule interventions name: Ketac Universal Aplicap Glass Ionomer Restorative (3M) (test group), interventions name: Ketac Molar Quick Aplicap Glass Ionomer Restorative (control group), outcomesModule primaryOutcomes measure: Restoration survival over time based on the glass ionomer restoration criteria, secondaryOutcomes measure: Evaluation of restoration quality based on the glass ionomer restoration criteria, secondaryOutcomes measure: Evaluation of restoration wear based on comparison of digital impressions, secondaryOutcomes measure: Safety Endpoint: The safety endpoint is the incidence of Adverse Events., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 66 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dental Health Clinic at Universidad Europea de Madrid (UEM) Department of Prosthodontics, city: Madrid, zip: 28045, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False