CTRI/2024/02/063034尚未招募不适用
Assessment of Osteoprotegerin (OPG) and implant stability through the Topical application of UV irradiated Vitamin D on implant surface during placement :A Randomized controlled clinical trial
King georges medical university1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年3月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- osteoprotegerin biomarker
研究概览
简要总结
| Dental implants have |
| revolutionized oral rehabilitation, after 10 years of continuous follow-up, |
| it found that success rate of dental implants is 95%. Osteoprotegerin |
| (OPG) and receptor activator of nuclear factor kappa B ligand (RANKL) are |
| osteoblast-derived factors that compete for binding to the same RANK receptor |
| location and have regulating effects on osteoclastogenesis. Osteoprotegerin belongs to the tumor |
| necrosis factor receptor superfamily and it encodes for type I transmembrane |
| glycoproteins. Osteoprotegerin (OPG), also referred to as osteoclast |
| inhibiting factor, is a soluble decoy receptor that can be located in the |
| body. In growing bone, OPG amounts are high and its expression is increased |
| by bone morphogenetic protein (BMP), IL1, TNF, TGF and estrogen. Biochemical changes can be achieved by topically applying biological mediators |
| to the device surface and by applying substances with systemic effects, such |
| as bisphosphonates. (5,6) The term "Vitamin D" applies to a class |
| of vitamin kinds derived from fatty steroid hormones. Ergocalciferol and cholecalciferol |
| are two forms of Vitamin |
| D. Calcitriol, another name for Vitamin D3, is the most |
| active type of Vitamin D and is synthesized when skin cholesterol is exposed |
| to UV radiation. Vitamin D plays a crucial part in maintaining the biological |
| equilibrium of bone and calcium because it directly contributes to calcium |
| absorption in the body. Additionally, this molecule decreases calcium and |
| phosphorus loss while increasing bone reabsorption. osteoblasts |
| cells contain Vitamin D receptors. The production of genes is |
| also regulated by Vitamin D. The effectiveness of tooth implants is |
| significantly influenced by implant stability. Implant stability can be |
| divided into two categories: biological stability, which results from |
| osseointegration, and mechanical stability, which happens between the implant |
| and bone. Collagen fibers, carbohydrates, cells, and calcium, which comprise |
| the four main components of bone. Remodeling and hardening of bone occur |
| constantly. Remodeling may be mechanical, medical, or biochemical. Following |
| the stretching of the periodontal ligament fibers caused by the application |
| of an orthodontic force, regions of compression and strain form. Osteoblastic |
| activity can be seen in areas of strain while osteoclastic activity can be |
| seen in regions of compression. |
Aim of the study is to Evaluation of salivary Osteoprotegerin (OPG) through UV irradiated topical application of Vitamin Don implant surface during placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with edentulous space in the maxillary jaw having healed bone site indicated for rehabilitation with implants.
- •Patient having sufficient residual bone volume for implant placement.
- •Patient having good general health with no systemic disease.
- •Patient having adequate oral hygiene.
- •Good general and periodontal health.
排除标准
- •Patients who consume alcohol, smoke or use illicit drugs.
- •Patient with any systemic disease, irradiated patients, patients with previous or active treatments with steroids or bisphosphonates
- •Pregnant/lactating women
- •Systemic diseases which can affect bone metabolism such as osteoporosis and endocrine diseases
- •Patients taking antibiotics/steroids/anti inflammatory for the past 3 months.
结局指标
主要结局
osteoprotegerin biomarker
时间窗: 0 weeks, 2 weeks, 12 weeks
次要结局
- implant stability(crestal bone loss)
研究者
Ruby Singh
King Georges medical university
研究点 (1)
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