Influence of the Osteoimplant Vitamin Complex on the Stability of Dental Implants. Randomized Double-blind Clinical Trial.
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- IMPLANT STABILITY
研究概览
简要总结
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:
'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'.
As secondary objectives, we will also evaluate the effect of Osteoimplant© and Osteoimplant Complex© on pain, postoperative inflammation and soft tissue healing.
The 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:
- 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.
- 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.
详细描述
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:
'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'.
As secondary objectives, we will also evaluate the effect of Osteoimplant© and Osteoimplant Complex© on pain, postoperative inflammation and soft tissue healing.
The 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:
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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 Osteimplant Complex©.
- •Signed informed consent.
排除标准
- •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 Osteimplant Complex©.
- •Patients undergoing treatment with drugs that could affect the bone regeneration process, such as chemotherapy drugs, bisphosphonates, corticosteroids or immunosuppressants.
- •Patients with metabolic bone diseases or who have undergone radiotherapy in the last five years.
- •Patients with hypercalcaemia or a tendency to hypercalcification, taking vitamin D or calcium supplements.
- •Patients with a history of renal colic.
- •Patients who are not going to undergo nephrotic colic.
结局指标
主要结局
IMPLANT STABILITY
时间窗: From implant placement until 12 weeks
All implants will be placed following the same surgical protocol and in strict compliance with the implant manufacturer's instructions regarding the drilling protocol associated with the patient's bone quality. Once the implants are placed, stability measurements shall be taken with the Osstell ISQ and the stability levels of the implants shall be evaluated at different stages of treatment by performing the following measurements: 1. First measurement: after implant placement surgery. We will evaluate the primary stability. 2. Second measurement: at 8 weeks to determine the evolution of osseointegration throughout the healing process of our implants. 3. Third measurement: at 12 weeks to assess the evolution of osseointegration again before 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:
次要结局
未报告次要终点
研究者
Francisco Javier Manzano-Moreno
PhD, Doctor in Dental Surgery
Universidad de Granada