Osteoimplant and Dental Implants Stability

Based on the scientific evidence, the relevance of this subject, we consider this studyto be justified, the general or specific objective of which is as follows:'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 implantsurgery'.As secondary objectives, we will also evaluate the effect of Osteoimplant© andOsteoimplant Complex© on pain, postoperative inflammation and soft tissue healing.The sample will consist of 60 patients. The sample will be randomly divided into 2 groupsusing a randomisation table generated by a statistical programme. For blinding, neitherthe 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. Patientsshall be assigned to one of the following groups: ‐ Group I: 30 patients prescribed to take Osteoimplant Complex© on the followingschedule: 2 tablets per day starting 5 days before implant placement and 1 tabletper day of Osteimplant© for 2 months after implant placement. ‐ Group II: 30 patients who were prescribed placebo with the following regimen: 2tablets per day starting 5 days before implant placement and 1 tablet per day for 2months after implant placement.3.1. Study design Our study is a double‐blind randomised clinical trial (RCT) to evaluatethe stability of the implants in the different phases of treatment: at the time ofinsertion (primary stability), at 8 and 12 weeks (secondary stability). Postoperativepain and swelling will also be studied.Composition of nutritional supplements. ‐ The preoperative nutritional supplement corresponds to Osteoimplant Complex® and iscomposed of: vitamin C 48.5 mg, coenzyme Q10 41.3 mg, Zinc 35 mg, beta‐carotene 10%25 mg, bioflavonoids citrus 60% 20.83 mg, vitamin E and magnesium 15 mg. ‐ The post‐operative nutritional supplement corresponds to Osteoimplant®, and iscomposed of: Ovocet ®, collagen 350 mg, calcium 300 mg, vitamin D3 100IU/mg,magnesium 8 mg.Patients Conceptual or target population Patients with partial or total single toothedentulism requiring rehabilitation with intraosseous implants.Study or accessible population The patients who will form part of our study will be thosewho attend the Master's Degree in Oral Surgery and Implantology of the Faculty ofDentistry of the University of Granada requesting dental implants for theirrehabilitation.All patients will undergo a clinical history and subsequent clinical examination. Theclinical history will consist of an anamnesis, where the patient's personal details willbe collected (name, age, sex, profession, address and telephone number), as well asfamily history, illnesses suffered, previous surgical interventions, drug allergies andcurrent treatment. Subsequently, an intraoral and extraoral examination will be carriedout, consisting of inspection and palpation of the bucco‐facial territory.To complement our examination and make a correct diagnosis, all patients will undergo aradiological study as a step prior to surgery, which will always consist of anorthopantomography, the usual projection for this type of intervention, with which acorrect diagnosis can be made. In addition, we will complete the study with a CBCT inorder to assess three‐dimensionally the relationship with anatomical structures and theavailability of bone.Once the diagnosis has been correctly made, the patient will be informed, both orally andin writing, of the possible complications that may arise in this type of surgery. Thefollowing inclusion and exclusion criteria will be applied to the target population forparticipation in the study:Inclusion criteria: ‐ Patients presenting with unitary or partial edentulism. ‐ Age: Between 18‐75 years. ‐ Anaesthetic risk ASA I‐II. ‐ Patients who do not abuse alcohol, drugs or chronic smoking (>10 cigarettes/day). ‐ Patients with adequate periodontal status (≤10% plaque index and bleeding index). ‐ Absence of drug allergies that could compromise our study. ‐ Absence of allergy to any of the components of Osteoimplant© and OsteimplantComplex©. ‐ Signed informed consent.Exclusion criteria: ‐ Age not between 18‐75 years old. ‐ Pregnant or breastfeeding women. ‐ Chronic smokers (>10 cigarettes/day). ‐ Patients with decompensated metabolic disease. ‐ Poor periodontal status (≥10% plaque index and bleeding index). ‐ Patients allergic to any of the components of Osteoimplant© and OsteimplantComplex©. ‐ Patients undergoing treatment with drugs that could affect the bone regenerationprocess, such as chemotherapy drugs, bisphosphonates, corticosteroids orimmunosuppressants. ‐ Patients with metabolic bone diseases or who have undergone radiotherapy in the lastfive years. ‐ Patients with hypercalcaemia or a tendency to hypercalcification, taking vitamin Dor calcium supplements. ‐ Patients with a history of renal colic. ‐ Patients who are not going to undergo nephrotic colic. 1. Surgical Protocol First ofall, the patient rinses with 0.12% chlorhexidine. After 1 minute, the area to beimplanted is anaesthetised using a truncal block or infiltrative technique with 4%articaine together with epinephrine. A transcrestal or paracrestal incision is made,depending on the case, and the mucoperiosteal flap is detached. Once detached, theposition of the implant will be determined thanks to the in situ visualisation ofthe bone thickness and the previous CBCT study of each patient. Subsequently, thedrilling sequence is determined by the company itself. Once the implant bed has beencreated, we will proceed to insert the implant with a torque of at least 30‐45N. Atthis point, the first stability measurement will be taken, then the cover screw willbe placed and the flap and suture will be repositioned. The patient will be reviewedand given a series of postoperative guidelines in physical format, which it isessential to follow for a correct result of our surgery.All implants will be placed following the same surgical protocol and in strict compliancewith the implant manufacturer's instructions regarding the drilling protocol associatedwith the patient's bone quality.Once the implants are placed, stability measurements shall be taken with the Osstell ISQand the stability levels of the implants shall be evaluated at different stages oftreatment by performing the following measurements: 1. First measurement: after implant placement surgery. We will evaluate the primarystability. 2. Second measurement: at 8 weeks to determine the evolution of osseointegrationthroughout the healing process of our implants. 3. Third measurement: at 12 weeks to assess the evolution of osseointegration againbefore subjecting the implant to occlusal loads.Prior to implant placement, each patient will be assigned to a study group, where,depending on their assignment, they will receive either placebo or the drug in question:Preoperative phase: ‐ Group I: prescribed to take Osteoimplant Complex ® 2 every 24 hours, 5 days prior tosurgery. ‐ Group II: prescribed to take placebo 2 every 24 hours, 5 days prior to surgery.Post‐operative phase: ‐ Group I: prescribed to take Osteoimplant® 1 every 24 hours, for 8 weeks aftersurgery. ‐ Group II: prescribed placebo 1 every 24 hours for 8 weeks after surgery. In bothgroups, an antibiotic treatment of amoxicillin 500 mg, 1 every 8 hours for 5 days isadministered. In case of penicillin allergy, the drug of choice will be clindamycin300 mg 1 every 8 hours for 5 days; as well as an analgesic and anti‐inflammatorytreatment: ibuprofen 400 mg 1 every 8 hours for 2 days, from the third day ondemand. As rescue medication paracetamol 1 g.