[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645642":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":42,"locations":51,"responsibleParty":62,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":23,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":54,"whyStopped":26,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Minia University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cention N","EXPERIMENTAL","Following local anesthesia, rubber dam isolation, caries removal, and cavity preparation, enamel etching and adhesive application were performed, Cention N was hand-mixed according to the manufacturer's instructions (1 scoop powder:1 drop liquid), placed into the prepared cavity, adapted to the cavity walls, and condensed to ensure optimal marginal adaptation. Optional light curing for 20 seconds was performed, followed by finishing and polishing to obtain the final restoration.",[13],"Device: Cention-N",{"label":15,"type":16,"description":17,"interventionNames":18},"Resin Composite","ACTIVE_COMPARATOR","Following local anesthesia and rubber dam isolation, caries removal and cavity preparation were performed using a high-speed diamond bur under water cooling. Enamel margins were etched with 37% phosphoric acid for 30 seconds, rinsed, gently air-dried, and an adhesive system was applied and light-cured according to the manufacturer's instructions. The cavity was then restored with a bioactive injectable resin composite placed directly into the cavity and light-cured for 20 seconds. Finishing and polishing procedures were performed to achieve proper anatomical contour and smooth surface",[19],"Device: Resin Composite",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Cention-N","Following local anesthesia, rubber dam isolation, caries removal, and cavity preparation, enamel etching and adhesive application were performed. Cention N was hand-mixed according to the manufacturer's instructions (1 scoop powder:1 drop liquid), placed into the prepared cavity, adapted to the cavity walls, and condensed to ensure optimal marginal adaptation. Optional light curing for 20 seconds was performed, followed by finishing and polishing to obtain the final restoration.",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Following local anesthesia and rubber dam isolation, caries removal and cavity preparation were performed using a high-speed diamond bur under water cooling. Enamel margins were etched with 37% phosphoric acid for 30 seconds, rinsed, gently air-dried, and an adhesive system was applied and light-cured according to the manufacturer's instructions. The cavity was then restored with a bioactive injectable resin composite placed directly into the cavity and light-cured for 20 seconds. Finishing and polishing procedures were performed to achieve proper anatomical contour and smooth surface.",[15],[31,35,39],{"name":32,"affiliation":33,"role":34},"Rehab Gamal Madani, bachelor of dentistry","Faculty of Dentistry, Assiute University","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":38},"Ahmed Abdelhamid Elheeny, PhD","Faculty of Dentistry, Minia University","STUDY_CHAIR",{"name":40,"affiliation":33,"role":41},"Moustafa Mohamed Sayed, PhD","STUDY_DIRECTOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":26,"email":47},"Rehab Gamal Madani, master","CONTACT","+201010498491","rehab.gamal89pg@dent.s-mu.edu.eg",{"name":36,"role":45,"phone":49,"phoneExt":26,"email":50},"00201064257135","ahmedelheeny@mu.edu.eg",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":26,"country":57,"countryCode":58,"cosmosGeoPoint":26,"geoPoint":26,"contacts":59},"Faculty of Dentistry, Minya university","RECRUITING","Minya","Asyut Governorate","Egypt","EG",[60,61],{"name":36,"role":45,"phone":49,"phoneExt":26,"email":50},{"name":32,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":34,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Rehab Gamal Mohamed Ahmed","Demonstrator of pediatric dentistry","100645642","clinical-and-radiographic-assessment-of-first-permanent-molars-with-cention-n-100645642",false,"NCT07703176","Clinical and Radiographic Assessment of First Permanent Molars With Cention-N","Assessment of Clinical, Radiographic, and Oral Health-Related Quality of Life Following Restoration of First Permanent Molars With Cention-N: A 12-Month Split-Mouth Randomized Controlled Trial","Inclusion Criteria:\n\nClinical:\n\n1. Children aged 8-10 years.\n2. Children classified as ASA physical status I or II.\n3. Children demonstrate positive or definitely positive behavior (scores 3 or 4 on the Frankl Behavior Rating Scale).\n4. Children who are available for regular recall visits throughout the study period.\n5. Presence of bilateral carious lesions in permanent first molars, with a clear description of lesion depth whenever possible.\n6. Asymptomatic vital permanent first molars showing no clinical or radiographic signs of pathology.\n\nRadiographic:\n\n1. Normal lamina dura and periodontal ligament space.\n2. No apical radiolucency.\n\nExclusion Criteria:\n\nClinical:\n\n1. Children with behavioral difficulties or without signed parental consent.\n2. Children are classified as ASA physical status class III or higher.\n3. Teeth presenting clinical signs of pulpitis or necrosis (e.g., nocturnal pain, fistula, abscess, pulp exposure, or pathological mobility).\n\nRadiographic:\n\n1. Evidence of abnormal radiolucency involving the pulp chamber or root apex.\n2. Detection of furcal bone radiolucency or abnormal root resorption.","ALL","8 Years","10 Years",{"count":76,"type":77},100,"ESTIMATED","INTERVENTIONAL",[80],"NA",": Assessment of Clinical, Radiographic, and Oral Health-Related Quality of Life Following Restoration of First Permanent Molars with Cention N: A 12-Month Split-Mouth Randomized Controlled Trial\n\nIntroduction\n\nDental caries is one of the most common chronic diseases affecting children. First permanent molars (FPMs) are particularly susceptible to caries because of their early eruption and complex occlusal anatomy. Restorative treatment aims to preserve tooth function and prevent disease progression. Composite resin is widely used because of its esthetics and mechanical properties; however, polymerization shrinkage may compromise marginal integrity. Cention N is a newer alkasite restorative material that releases fluoride, calcium, and hydroxide ions, promoting remineralization and enhancing caries resistance. Since treatment success should include both clinical outcomes and patient-centered outcomes, oral health-related quality of life (OHRQoL) will also be assessed.\n\nAim\n\nTo compare the clinical and radiographic performance of Cention N and bioactive injectable resin composite in restoring first permanent molars over 12 months. A secondary objective is to evaluate changes in children's oral health-related quality of life.\n\nMaterials and Methods\n\nThis will be a split-mouth randomized controlled clinical trial involving 100 children aged 8-10 years.\n\nInclusion criteria:\n\nHealthy children (ASA I or II). Positive\u002Fdefinitely positive behavior (Frankl 3 or 4). Bilateral carious first permanent molars. Vital, asymptomatic teeth without radiographic pathology.\n\nExclusion criteria:\n\nLack of parental consent. ASA III or higher. Teeth with signs of irreversible pulp disease or radiographic pathology.\n\nEthical approval will be obtained from the Research Ethics Committee, Faculty of Dentistry, Minia University, and written informed consent will be obtained from parents.\n\nClinical Procedure\n\nFollowing clinical and radiographic examination, local anesthesia and rubber dam isolation will be performed. Caries will be removed conservatively, followed by acid etching and adhesive application.\n\nOne molar will be restored with bioactive injectable resin composite according to the manufacturer's instructions.\n\nThe contralateral molar will be restored with Cention N, mixed and placed according to the manufacturer's instructions, with optional light curing.\n\nAll restorations will be finished and polished using standardized procedures.\n\nOutcome Assessment\n\nPrimary outcome\n\nClinical and radiographic evaluation at 3, 6, and 12 months using the modified USPHS criteria, including:\n\nColor match Marginal adaptation Marginal discoloration Anatomic form Secondary caries Restoration integrity\n\nSecondary outcome Assessment of oral health-related quality of life using the Child Perceptions Questionnaire (CPQ8-10), which evaluates oral symptoms, functional limitations, emotional well-being, and social well-being.\n\nStatistical Analysis\n\nCollected data will be tabulated and analyzed using appropriate statistical methods to compare the performance of both restorative materials over the follow-up period.",[83],"Dental Caries",[85],"Cention N Clinical Trial","2026-07-13",{"date":88,"type":89},"2026-07-15","ACTUAL",{"date":91,"type":89},"2026-03-09",{"date":93,"type":77},"2027-09-09",{"name":5,"class":6},1]