[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588004":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":73,"collaborators":77,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":92,"maxAge":26,"enrollmentInfo":93,"targetDuration":26,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":26,"overallStatus":104,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of Santiago de Compostela","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BTCP Group","EXPERIMENTAL","The experimental BTCP group includes participants who will receive BTCP after the extraction of an impacted mandibular third molar to test its osteogenic properties. BTCP is prepared according to the manufacturer's instructions, initially by immersing it in sterile saline solution. It is applied to the socket after extraction using specialized instruments and is compared with a control group that receives Bio-Oss, a standard xenograft material.\n\nPatients in the experimental group receive postoperative medication, including antibiotics and pain management treatment. Follow-up evaluations assess pain, inflammation, complications, and bone regeneration through radiological assessment.\n\nObjective: To evaluate the efficacy of BTCP in bone regeneration compared to the control.",[13],"Combination Product: Medical device: beta-tricalcium phosphate",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","The control group serves as the active comparator to the BTCP experimental group in this study. Participants undergo the same impacted mandibular third molar extraction procedures as those in the experimental group, but receive a standard material, Bio-Oss, instead of BTCP.\n\nBio-Oss, a widely used xenograft material in dental surgeries, serves as the reference due to its osteoconductive properties. It is applied to the socket after extraction using specialized instruments and acts as a benchmark for comparing the efficacy of BTCP. Patients in the control group receive postoperative medication according to the study protocol, including antibiotics and pain management treatment. Follow-up assessments evaluate pain, inflammation, complications, and bone regeneration through radiological evaluation.",[19],"Other: Bovine Hydroxyapatite",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","Medical device: beta-tricalcium phosphate","The description of the intervention for BTCP in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. BTCP is indicated for the treatment of segmental and cavitary bone loss, aesthetic repairs, and bone augmentations (such as inlay or onlay grafts); for filling dental alveolar bone; for dental implant placement; and for the stabilization of osteotomies and prostheses in dentistry.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Bovine Hydroxyapatite","The intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties.",[15],[32,36],{"name":33,"affiliation":34,"role":35},"Fabio Camacho Alonso, phD","Universidad de Murcia","PRINCIPAL_INVESTIGATOR",{"name":37,"affiliation":38,"role":39},"Abel García García, phD","Universidade de Santiago de Compostela","STUDY_CHAIR",[41],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"MARIO PEREZ-SAYANS GARCIA, PHD, PHD","CONTACT","+34626233504","mario.perez@usc.es",[47,62],{"facility":38,"status":26,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Santiago de Compostela","A Coruña","15705","Spain","ES",{"type":54,"coordinates":55},"Point",[56,57],-8.54569,42.88052,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":26,"phoneExt":26,"email":45},"Mario Pérez-Sayáns, PHD,PHD",{"facility":63,"status":26,"city":64,"state":64,"zip":26,"country":51,"countryCode":52,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"University of Murcia","Murcia",{"type":54,"coordinates":66},[67,68],-1.13004,37.98704,{"lat":68,"lon":67},[71],{"name":72,"role":43,"phone":26,"phoneExt":26,"email":26},"Fabio Camacho Alonso",{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Mario Pérez Sayáns","Professor",[78,79],{"name":34,"class":6},{"name":80,"class":81},"Nueva Galimplant SLU","UNKNOWN","100588004","phase-4-osteogenic-action-of-a-medical-device-based-on-beta-tricalcium-phosphate-btcp-100588004",false,"NCT06935747","Osteogenic Action of a Medical Device Based on Beta-tricalcium Phosphate (BTCP)","Clinical Study to Analyze the Osteogenic Action of a Beta-tricalcium Phosphate-based Product in Bone Regeneration After the Extraction of Impacted Mandibular Third Molars.","BTCP","Inclusion Criteria:\n\n* Patients must be of legal age, generally defined as 18 years or older, to be able to provide adequate informed consent and understand the risks and benefits of the procedure.\n* Informed Consent: Patients must be willing to provide written informed consent to participate in the study, indicating their understanding and acceptance of the associated procedures and risks.\n* Need for Extraction of Impacted Mandibular Third Molars: Patients must require the extraction of both impacted mandibular third molars to be eligible for the study.\n* Similar Complexity of Impacted Third Molars: The impacted mandibular third molars must present similar complexity for extraction on both sides of the jaw, to ensure a fair comparison between the study groups.\n* Absence of Medical Contraindications for Oral Surgical Procedures: Patients must not have significant medical contraindications that would prevent oral surgical procedures, such as clotting disorders, uncontrolled systemic diseases, or a history of severe infections.\n\nExclusion Criteria:\n\n* Severe Mental Disorders: Patients with severe mental disorders that may affect their ability to understand and follow study instructions may be excluded due to concerns about their capacity to provide valid informed consent and follow the study protocol.\n* Contraindications for Dental Extractions: Patients with specific contraindications for dental extraction, such as a history of osteonecrosis of the jaws or serious complications associated with previous dental procedures, may be excluded for safety reasons.\n* Patients under the age of 18 will not be eligible to participate in the study due to ethical and legal concerns related to obtaining informed consent and the ability to understand the risks and benefits of the study.\n\nWithdrawal from the Study:\n\n-If a patient experiences severe complications during the study, such as severe postoperative infections, severe allergic reactions, or any other adverse event that may jeopardize their health, they will be considered for withdrawal from the study to ensure their well-being. Additionally, if a patient decides to voluntarily withdraw from the study at any time, their decision will be respected, and appropriate medical care will be provided as needed.",true,"ALL","18 Years",{"count":94,"type":95},30,"ESTIMATED","INTERVENTIONAL",[98],"PHASE4","The general objective of this split-mouth study is to analyze the osteogenic action of BTCP during the bone regeneration process following the extraction of impacted mandibular third molars.",[101,102,103],"Bone Loss","Regenerative Inflammation","Third Molars Extraction","NOT_YET_RECRUITING","2025-04-21",{"date":107,"type":108},"2025-04-24","ACTUAL",{"date":110,"type":95},"2025-07",{"date":112,"type":95},"2026-07",{"name":75,"class":6},2]