[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566618":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":49,"sex":50,"minAge":51,"maxAge":26,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Universidad de Granada","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OSTEOIMPLANT GROUP","EXPERIMENTAL","patients prescribed to take Osteoimplant Complex© on the following schedule: 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant© for 2 months after implant placement.",[13],"Dietary Supplement: osteoimplant",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Group","PLACEBO_COMPARATOR","30 patients who were prescribed placebo with the following regimen: 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement.",[19],"Dietary Supplement: Placebo Oral Tablet",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","osteoimplant","Osteoimplant Complex© on the following schedule: 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant© for 2 months after implant placement.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo Oral Tablet","2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"FRANCISCO JAVIER MANZANO-MORENO Prof. Dr. Francisco Javier Manzano-Moreno, PhD, DDS","CONTACT","+34651606228","fjmanza@ugr.es",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Francisco Javier Manzano-Moreno","PhD, Doctor in Dental Surgery","100566618","early-phase-1-osteoimplant-and-dental-implants-stability-100566618",false,"NCT06657521","Osteoimplant and Dental Implants Stability","Influence of the Osteoimplant Vitamin Complex on the Stability of Dental Implants. Randomized Double-blind Clinical Trial.","OIMP","Inclusion Criteria:\n\n* Patients presenting with unitary or partial edentulism.\n\n  * Age: Between 18-75 years.\n  * Anaesthetic risk ASA I-II.\n  * Patients who do not abuse alcohol, drugs or chronic smoking (\\>10 cigarettes\u002Fday).\n  * Patients with adequate periodontal status (≤10% plaque index and bleeding index).\n  * Absence of drug allergies that could compromise our study.\n  * Absence of allergy to any of the components of Osteoimplant© and Osteimplant Complex©.\n  * Signed informed consent.\n\nExclusion Criteria:\n\n* Age not between 18-75 years old.\n* Pregnant or breastfeeding women.\n* Chronic smokers (\\>10 cigarettes\u002Fday).\n* Patients with decompensated metabolic disease.\n* Poor periodontal status (≥10% plaque index and bleeding index).\n* Patients allergic to any of the components of Osteoimplant© and Osteimplant Complex©.\n* Patients undergoing treatment with drugs that could affect the bone regeneration 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.\n* Patients with hypercalcaemia or a tendency to hypercalcification, taking vitamin D or calcium supplements.\n* Patients with a history of renal colic.\n* Patients who are not going to undergo nephrotic colic.",true,"ALL","18 Years",{"count":53,"type":54},60,"ESTIMATED","INTERVENTIONAL",[57],"EARLY_PHASE1","Based on the scientific evidence, the relevance of this subject, we consider this study to be justified, the general or specific objective of which is as follows:\n\n'To evaluate the effect of the administration of Osteoimplant© and Osteoimplant Complex© as a food supplement in obtaining implant stability and in the healing of dental implant surgery'.\n\nAs secondary objectives, we will also evaluate the effect of Osteoimplant© and Osteoimplant Complex© on pain, postoperative inflammation and soft tissue healing.\n\nThe sample will consist of 60 patients. The sample will be randomly divided into 2 groups using a randomisation table generated by a statistical programme. For blinding, neither the patient nor the operator shall be aware of the group to which each patient belongs. To ensure blinding, medication will be delivered in sealed, opaque envelopes. Patients shall be assigned to one of the following groups:\n\n* Group I: 30 patients prescribed to take Osteoimplant Complex© on the following schedule: 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant© for 2 months after implant placement.\n* Group II: 30 patients who were prescribed placebo with the following regimen: 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement.",[60,61],"Primary Stability of the Implants","Pain",[63,64,65,66,67,68],"Dental implant","vitamin c","vitamin D","stability","pain","inflamation","NOT_YET_RECRUITING","2024-10-23",{"date":72,"type":73},"2024-10-24","ACTUAL",{"date":75,"type":54},"2025-01-01",{"date":77,"type":54},"2025-12-31",{"name":5,"class":6}]