[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595386":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":41,"locations":52,"responsibleParty":66,"collaborators":32,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":32,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":55,"whyStopped":32,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Universidad de Granada","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"drug intervention: Gel SM","EXPERIMENTAL","30 lower third molars in whose alveolus post-extraction we will place simvastatin gel at 1.2%.",[13],"Drug: Simvastatin",{"label":15,"type":16,"description":17,"interventionNames":18},"Drug intervention: Sm + collagen sponge","ACTIVE_COMPARATOR","30 lower third molars in whose alveolus post-extraction we will place a collagen sponge impregnated with saline solution containing 10 mg of simvastatin.",[19],"Drug: Simvastatin 10 mg",{"label":21,"type":22,"description":23,"interventionNames":24},"Control","PLACEBO_COMPARATOR","30 lower third molars in whose alveolus post-extraction we will place a collagen sponge impregnated with gel without simvastatin",[25],"Drug: Simvastatin Placebo",[27,33,37],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Simvastatin","Simvastatin gel with 1.2% simvastatin",[9],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"Simvastatin 10 mg","sponge of collagen impregned in saline solution with 10 mg of simvastatin",[15],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"Simvastatin Placebo","Collagen sponge impregned in simvastatin placebo gel without simvastatin",[21],[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Manzano-Moreno FJ Francisco Javier Manzano-Moreno","CONTACT","+34651606228","+34","fjmanza@ugr.es",{"name":49,"role":44,"phone":50,"phoneExt":46,"email":51},"Lopez-Andrade E Elena López-Andrade","+34656821779","elenitandrade@correo.ugr.es",[53],{"facility":54,"status":55,"city":56,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":32},"UGranada","RECRUITING","Granada","18071","Spain","ES",{"type":61,"coordinates":62},"Point",[63,64],-3.60667,37.18817,{"lat":64,"lon":63},{"type":67,"investigatorFullName":68,"investigatorTitle":69,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Francisco Javier Manzano-Moreno","PhD, DDS","100595386","early-phase-1-topic-simvastatin-for-bone-regeneration-100595386",false,"NCT07031778","Topic Simvastatin for Bone Regeneration","Efficacy of Topical Application of Simvastatin in Bone Regeneration","SM","Inclusion Criteria:\n\n* Anesthetic risk ASA I-II.\n* Patients with the adjacent tooth in the mouth (37 or 47).\n* Third molars with fully developed roots.\n* Mandibular third molars included or semi-included.\n* With indication for extraction.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pregnant or lactating women.\n* Chronic smokers.\n* Patients with decompensated metabolic disease.\n* Patients with motor difficulties that prevent or hinder hygiene.\n* Patients who are using statins to treat hypercholesterolemia.\n* Patients under treatment with drugs that could affect the osseointegration process such as chemotherapy drugs, bisphosphonates, corticosteroids or immunosuppressants.\n* Patients with metabolic bone diseases or who have undergone radiotherapy in the last five years.",true,"ALL","18 Years","40 Years",{"count":83,"type":84},90,"ESTIMATED","INTERVENTIONAL",[87],"EARLY_PHASE1","The goal of this clinical trial is to evaluate the efficacy of topical application of simvastatin in bone regeneration in the maxillae, in the reduction of dimensional bone changes, using mandibular third molar surgery as a model and assessing bone healing at 12 weeks. We will also compare the two forms of intralveolar topical administration currently used to assess which is the best form of administration. The main questions it aims to answer are:\n\n* Can the topical application of simvastatin, used as a preservation material, improve the variations with respect to bone dimensions and density that occur after tooth extraction.\n* Can topical application of SM improve soft tissue healing.\n* Does the topical application of SM produce changes with respect to postoperative variables of pain, inflammation or trismus.\n* What is the best vehicle for topical SM administration?\n\nFor this purpose, the investigators will randomly place 4 topical treatment options in the postextraction alveoli:\n\n* SM in gel form\n* collagen sponge impregnated with saline solution containing 10 mg of SM\n* collagen sponge with placebo gel. All patients will undergo postoperative CBCT, which will be repeated at 12 weeks.\n\nIn addition, inflammation, trismus and pain variables will be measured preoperatively, at 24 hours, 3 and 7 days.",[90,91],"Dimensional Changes","Bone Density",[93,94,95,96],"simvastatin","bone density","dimensional changes","cbct scan","2025-06-12",{"date":99,"type":100},"2025-06-22","ACTUAL",{"date":102,"type":100},"2025-01-07",{"date":104,"type":84},"2025-12-31",{"name":5,"class":6},1]