[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659275":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":34,"overallOfficials":13,"centralContacts":40,"locations":46,"responsibleParty":66,"collaborators":13,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":13,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":13,"enrollmentInfo":79,"targetDuration":13,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":90,"whyStopped":13,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Cairo University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Proximal Contact Tightness","Proximal contact tightness will be evaluated according to the FDI criteria (item 8: approximal anatomical form). Clinical assessment will be performed using a dental floss test and calibrated metal blades (25-100 μm) to assess resistance at the proximal contact area. The outcome will be recorded according to the FDI grading scale (8.1-8.5), as described by Heintze et al. (2010).","Immediately After Restoration Placement (baseline)",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Parallel Assignment","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","This study is a two-arm, parallel-group randomized clinical trial comparing a Ni-Ti shape-memory sectional matrix system with a conventional sectional matrix system for Class II composite restorations. Eligible participants requiring Class II direct composite restorations will be randomly allocated to one of the two intervention groups. The proximal contact tightness will be evaluated as the primary outcome, while proximal contour quality and other relevant clinical parameters will be assessed as secondary outcomes. Clinical assessments will be performed immediately after restoration placement and at 1-year follow-up.",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"Ni-Ti Shape Memory Matrix System","EXPERIMENTAL","Participants will receive Class II composite restorations using a Quickmat-Flex ultra-thin titanium sectional matrix band combined with a Ni-Ti shape-memory separation ring.",[28],"Device: Ni-Ti Shape-Memory Sectional Matrix System",{"label":30,"type":31,"description":32,"interventionNames":33},"Conventional Sectional Matrix System","ACTIVE_COMPARATOR","Participants will receive Class II composite restorations using a conventional stainless-steel sectional matrix system (TOR VM) combined with a conventional separation ring.",[28],[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":13},"DEVICE","Ni-Ti Shape-Memory Sectional Matrix System","Intervention 1 - Ni-Ti Shape-Memory Sectional Matrix System\n\nQuickmat-Flex ultra-thin titanium sectional matrix band combined with a Ni-Ti shape-memory separation ring for restoration of Class II posterior composite cavities.\n\nIntervention 2 - Conventional Sectional Matrix System\n\nTOR VM stainless-steel sectional matrix system combined with a conventional separation ring for restoration of Class II posterior composite cavities.",[30,24],[41],{"name":42,"role":43,"phone":44,"phoneExt":13,"email":45},"Mahitab Kamal, BDS Cairo University","CONTACT","01019679235","mahitab.kamal@dentistry.cu.edu.eg",[47],{"facility":48,"status":13,"city":49,"state":50,"zip":13,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Faculty of Dentistry Cairo university","Cairo","Cairo Governorate","Egypt","EG",{"type":54,"coordinates":55},"Point",[56,57],31.24967,30.06263,{"lat":57,"lon":56},[60,62],{"name":61,"role":43,"phone":44,"phoneExt":13,"email":45},"Mahitab Ahmed Kamal, BDS",{"name":63,"role":43,"phone":64,"phoneExt":13,"email":65},"Omnia Magdy Kamal, Lecturer of Conservative Denti","01200055725","omnia.magdy@dentistry.cu.edu.eg",{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"PRINCIPAL_INVESTIGATOR","Mahitab Ahmed Anwar Kamal","Internal Resident at Faculty of dentistry Cairo University","100659275","ni-ti-shape-memory-versus-conventional-sectional-matrices-systems-in-class-ii-composite-restorations-a-randomized-clinical-trial-100659275",false,"NCT07862894","Ni-Ti Shape-Memory Versus Conventional Sectional Matrices Systems in Class II Composite Restorations: A Randomized Clinical Trial","Clinical Performance of Ni-Ti Shape-Memory Versus Conventional Sectional Matrices Systems in Class II Composite Restorations: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Adult patients (≥18 years) requiring Class II composite restorations in posterior teeth.\n\n  * Good oral hygiene and periodontal health.\n  * No systemic conditions affecting oral health.\n\nExclusion Criteria:\n\n* Patients with bruxism or parafunctional habits.\n\n  * Severe malocclusion interfering with proximal contacts.\n  * Allergy to dental materials used in the study.","ALL","18 Years",{"count":80,"type":81},50,"ESTIMATED","INTERVENTIONAL",[84],"NA","The aim of this randomized controlled clinical trial is to evaluate and compare the clinical performance of a Ni-Ti shape-memory sectional matrix system versus a conventional sectional matrix system in Class II direct composite restorations.\n\nThe study will specifically assess the following clinical parameters:\n\n1. Proximal contact tightness\n2. Proximal contour quality\n3. Fracture and retention of the restoration\n4. Marginal adaptation These clinical parameters will be evaluated immediately after restoration placement and after a 1-year follow-up using standardized clinical assessment methods, including the FDI criteria, dental floss evaluation, and radiographic assessment, where applicable.\n\nFracture and retention, and marginal adaptation will be assessed according to predefined scoring criteria.",[87],"Class II Composite Restorations",[89],"Class II restorations; sectional matrix; Ni-Ti matrix; proximal contact tightness; proximal contour; randomized clinical trial","NOT_YET_RECRUITING","2026-10-02",{"date":93,"type":94},"2026-10-07","ACTUAL",{"date":96,"type":81},"2026-11-01",{"date":98,"type":81},"2028-01-01",{"name":5,"class":6},1]