[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592316":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":40,"responsibleParty":62,"collaborators":25,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":25,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":43,"whyStopped":25,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard PAE Protocol Group","ACTIVE_COMPARATOR","In this arm, participants will receive a Class III or Class IV resin-based composite (RBC) restoration with a standard etch-and-rinse bonding protocol. Phosphoric acid etching (PAE) will be applied to both enamel and dentin for 15-30 seconds and 10-15 seconds, respectively. After etching, a universal adhesive will be applied, followed by the placement of the RBC using a standard layering technique with separately photo-polymerized increments. The final restoration will be polished to ensure proper contour and surface finish.",[13],"Procedure: Permanent dental restoration",{"label":15,"type":16,"description":17,"interventionNames":18},"Reduced PAE Duration Protocol Group","EXPERIMENTAL","Participants in this arm will receive Class III or Class IV RBC restorations using a reduced PAE duration protocol. Phosphoric acid etching will be applied simultaneously to both enamel and dentin for a brief 10-second period, followed by the application of the universal adhesive and placement of the RBC. Similar to the standard protocol group, the restoration will be placed using a layering technique with photo-polymerized increments and polished to completion. This group aims to evaluate the effect of a reduced etching time on restorative outcomes compared to the standard PAE protocol.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Permanent dental restoration","In both study arms, permanent dental restorations are made with resin-based composite in permanent anterior teeth. Both study arms will use identical materials for the resin-based composite restoration (Tetric Plus Flow and Tetric Plus Fill) and universal adhesive (Adhese Universal), with the only difference being the duration of the phosphoric acid etching step. All other aspects of the restorative procedure, such as isolation of the operative field, application techniques, and final polishing, will remain consistent across both arms.",[15,9],null,[27],{"name":28,"affiliation":29,"role":30},"Florin Eggmann, PD Dr. med. dent.","University of Basel","PRINCIPAL_INVESTIGATOR",[32,36],{"name":28,"role":33,"phone":34,"phoneExt":25,"email":35},"CONTACT","+41 61 267 26 80","florin.eggmann@unibas.ch",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Roland Weiger, Prof. Dr. med. dent.","+41 61 267 26 25","roland.weiger@unibas.ch",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University Center for Dental Medicine Basel UZB","RECRUITING","Basel","Canton of Basel-City","4058","Switzerland","CH",{"type":50,"coordinates":51},"Point",[52,53],7.57327,47.55839,{"lat":53,"lon":52},[56,57,61],{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},{"name":58,"role":33,"phone":59,"phoneExt":25,"email":60},"Michael M. Bornstein, Prof. Dr. med. dent.","+41 61 267 25 25","michael.bornstein@unibas.ch",{"name":28,"role":30,"phone":25,"phoneExt":25,"email":25},{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Florin Eggmann","Sponsor-Investigator, Head of Cariology","100592316","effect-of-phosphoric-acid-etching-duration-on-direct-resin-based-composite-restorations-in-permanent-anterior-teeth-100592316",false,"NCT06991842","Effect of Phosphoric Acid Etching Duration on Direct Resin-Based Composite Restorations in Permanent Anterior Teeth","Effect of Phosphoric Acid Etching Duration on the Performance of Direct Resin-Based Composite Restorations in Permanent Anterior Teeth: A Randomized Controlled Single-Center Trial","ETCH-PRO","Inclusion Criteria:\n\nSigned informed consent by the participant\n\nAge 18 years or older\n\nIndication for a Class III or Class IV resin-based composite (RBC) restoration on an anterior permanent tooth due to one or more of the following conditions:\n\nProximal carious lesion with cavitation\n\nDefective restoration requiring replacement\n\nNecessary proximal reshaping due to developmental anomalies (e.g., peg teeth, proximal gaps from Bolton discrepancies, orthodontic tooth position, or esthetic concerns like black triangles caused by periodontal tissue recession)\n\nVital teeth with regular sensitivity\n\nSufficient language skills to understand and comply with study procedures\n\nPreoperative Visual Analog Scale (VAS) scores \\\u003C 3 for tooth sensitivity and biting discomfort\n\nGood oral hygiene, including the ability to maintain effective oral hygiene\n\nClinical periodontal health (intact periodontium or a reduced periodontium due to non-periodontal causes or after periodontal treatment)\n\nExclusion Criteria:\n\nInability to achieve sufficient isolation and contamination control during restorative procedures\n\nClass IV restoration required due to crown fracture, crown-root fracture, extensive tooth wear, or carious lesion affecting the incisal edge\n\nMissing antagonist tooth without prosthodontic replacement\n\nIntent to undergo professional tooth bleaching within five years following the Class III or IV restoration (Note: Professional tooth bleaching must be completed at least two weeks prior to study enrollment)\n\nKnown or suspected allergy to any constituents of the materials used (e.g., methacrylates or local anesthetics)\n\nPregnancy or lactation\n\nAcute or chronic health conditions that may impair study participation (e.g., systemic diseases, oral conditions, or treatments that interfere with study procedures)",true,"ALL","18 Years",{"count":78,"type":79},66,"ESTIMATED","INTERVENTIONAL",[82],"NA","The goal of this clinical trial is to learn if reducing the phosphoric acid etching (PAE) time affects the performance of direct resin-based composite (RBC) restorations in permanent anterior teeth. It will also learn about the safety of using a shortened PAE protocol. The main questions it aims to answer are:\n\nDoes a shorter PAE time lead to more or less marginal staining in restored teeth?\n\nWhat sensitivity or other clinical issues do participants experience after restoration using different PAE times?\n\nResearchers will compare a reduced PAE protocol to a standard PAE protocol to see how each affects the outcome of Class III and IV anterior restorations.\n\nParticipants will:\n\nReceive one or two direct RBC restorations using either a shortened or standard PAE protocol\n\nVisit the clinic for follow-ups at baseline, and at 1, 2, 3, and 5 years after restoration\n\nHave sensitivity and restoration quality evaluated using clinical exams, photographs, and questionnaires",[85,86,87],"Dental Restoration, Permanent","Dental Caries (Disorder)","Dental Restoration Failure",[89,90,91,92,93,94,95,22,96,97,98],"Resin-based composite","Universal adhesive","Class III restoration","Class IV restoration","Phosphoric acid etching","Adhesive dentistry","Anterior tooth restoration","Dental bonding","Etch-and-rinse technique","Restorative dentistry","2025-08-04",{"date":101,"type":102},"2025-08-05","ACTUAL",{"date":104,"type":102},"2025-06-01",{"date":106,"type":79},"2031-12-31",{"name":64,"class":6},1]