[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567121":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":28,"locations":11,"responsibleParty":34,"collaborators":11,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":65,"whyStopped":11,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":11},{"fullName":5,"class":6},"Universidad de Granada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"osteoimplant","EXPERIMENTAL",null,[13],"Drug: osteoimplant",{"label":15,"type":16,"description":11,"interventionNames":17},"placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","30 lower third molars will be selected and prescribed preoperative treatment with two units of Osteoimplant Complex® 5 days prior to surgery and postoperative treatment with one unit of Osteoimplant® for 8 weeks from the time of surgery. Both nutritional supplements will be administered every 24 hours.",[9],{"type":21,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Placebo","30 lower wisdom teeth will be selected and prescribed placebo, both preoperatively 5 days prior to surgery and postoperatively for 8 weeks from the time of surgery.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"FRANCISCO JAVIER MANZANO-MORENO MANZANO-MORENO, PhD","CONTACT","+34651606228","fjmanza@ugr.es",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Francisco Javier Manzano-Moreno","PhD, DDS","100567121","early-phase-1-osteoimplant-and-bone-healing-100567121",false,"NCT06664060","Osteoimplant and Bone Healing","Efficacy of Two Nutritional Supplements on Healing and Bone Density in the Jaws","Osteocic","Inclusion Criteria:\n\n* Patients presenting both lower third molars.\n* Adult patients between 18 and 40 years of age.\n* Anaesthetic risk ASA I-II (American Society of Anaesthesiologists classification) \\[14\\].\n* Absence of drug or food allergies that could compromise our study (e.g. egg).\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Age not between 18-40 years.\n* Pregnant or breastfeeding women.\n* Presenting decompensated metabolic disease.\n* Poor periodontal status (≥10% plaque index and bleeding index).\n* Patients who have undergone radiotherapy in the last five years.\n* Patients who will not comply with the study guidelines.\n* Unsigned informed consent.\n* History of allergy to any study medication or related drugs (e.g. egg).\n* Patients with a history of renal colic.",true,"ALL","18 Years","40 Years",{"count":51,"type":52},60,"ESTIMATED","INTERVENTIONAL",[55],"EARLY_PHASE1","In view of the above and the possible improvements in terms of postoperative morbidity and tissue repair in oral surgery, this study is justified, the general objective of which would be:\n\n'To evaluate the efficacy of perioperative oral administration of two nutritional supplements based on vitamins and antioxidants (Osteoimplant Complex® and Osteoimplant®), using mandibular third molar surgery as a study model, assessing postoperative symptomatology and bone density'.\n\nThe null hypothesis of this study is: 1) the administration of the perioperative nutritional complex (Osteoimplant Complex® and Osteoimplant®) did not improve postoperative symptoms and 2) neither did it increase bone density after lower third molar extraction.",[58,59],"Dimensional Changes","Bone Density",[61,62,63,64],"vitamin d","vitamin c","bone density","dimensional changes","NOT_YET_RECRUITING","2024-10-27",{"date":68,"type":69},"2024-10-29","ACTUAL",{"date":71,"type":52},"2025-01-07",{"date":73,"type":52},"2025-12-31",{"name":5,"class":6}]