[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616749":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":23,"responsibleParty":39,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":10,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":26,"whyStopped":10,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Mahidol University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Test",null,"Restoring with an injectable single shade composite resin using an injectable moulding technique",[13],{"name":14,"affiliation":15,"role":16},"Pipop Saikaew, PhD","Department of Operative Dentistry and Endodontics, Faculty of Dentistry, Mahidol University","STUDY_DIRECTOR",[18],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"Sawanya Prutthithaworn Dr, PhD","CONTACT","+662-200-7821","sawanya.pru@mahidol.ac.th",[24],{"facility":25,"status":26,"city":27,"state":10,"zip":10,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Pediatric Dental Clinic, Faculty of Dentistry, Mahidol University","RECRUITING","Bangkok","Thailand","TH",{"type":31,"coordinates":32},"Point",[33,34],100.50144,13.75398,{"lat":34,"lon":33},[37],{"name":38,"role":20,"phone":21,"phoneExt":10,"email":22},"Sawanya Prutthithaworn, Dr",{"type":40,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Sawanya Prutthithaworn","Principal Investigator","100616749","colour-match-stability-and-patients-satisfaction-of-single-shade-composites-in-anterior-teeth-100616749",false,"NCT07309653","Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth","Colour Matching, Stability, and Patient's Satisfaction in Maxillary Anterior Restorations Using Single-Shade Composite and Silicone-Guided Index: A 12-Month Clinical Evaluation","Inclusion Criteria:\n\n* Children who exhibit cooperative dental behaviours (rating 3 and 4) according to Frankl's behaviour rating scale (Frankl et al. 1962)\n* Presence of at least one maxillary anterior permanent tooth with one-third of crown structure loss from dental trauma\n* The affected tooth must be vital or have undergone vital pulp therapy (e.g., pulpotomy with Calcium hydroxide, white-MTA, or Biodentine)\n\nExclusion Criteria:\n\n* Known allergy to methacrylate-based materials\n* Presence of parafunctional habits, such as bruxism\n* Presence of rampant caries\n* Presence of signs of hypomineralisation, such as post-eruptive breakdown, hypersensitivity, changes in enamel texture and hardness, and abnormal translucency on radiographs.\n* The affected tooth is classified as having moderate or severe discolouration according to Dean's fluorosis index (Dean, 1942)\n* The affected tooth has lost less than one-third of its coronal crown structure\n* The affected tooth has a fracture located at the subgingival margin\n* The affected tooth requires splinting due to the severity of the trauma\n* Presence of severe malocclusion that could compromise the integrity of the restoration",true,"ALL","6 Years","15 Years",{"count":55,"type":56},23,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the clinical performance of a single-shade composite resin, used with an injection moulding technique, in restoring maxillary incisors affected by traumatic dental injury in patients aged 6-15 years.\n\nThe main questions it aims to answer are:\n\n* How well does a single composite resin colour match the natural tooth?\n* How stable is the colour over a 6- and 12-month follow-up?\n* How satisfied are the children and parents with the restoration?",[60,61],"Tooth Injuries","Dental Restoration, Permanent",[63,64,65,66,67,68,69],"Patient satisfaction","Color stability","Color matching","Single shade composter resins","Injection moulding technique","Flowable composite resins","Dental trauma","2025-12-29",{"date":72,"type":73},"2026-01-02","ACTUAL",{"date":75,"type":73},"2025-12-16",{"date":77,"type":56},"2027-10-28",{"name":5,"class":6},1]