Impact of Regular Home-use Dual Light Photodynamic Therapy in the Prevention of Osteolysis After Dental Implant Surgery
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Incidence of osteolysis around dental implants
研究概览
简要总结
The aim of the study is to determine whether regular use of the antibacterial, photodynamic, CE-marked Lumoral device reduces the risk of osteolysis after dental implant surgery. The study also aims to find out whether Lumoral treatment can replace the use of chlorhexidine. Subjects will be randomized into two groups (20 + 20 subjects) and all will be given individual guidance on maintaining good oral hygiene. The participants in the study group will also be given Lumoral appliances with instructions for use at home. The Lumoral device has been shown in previous studies to be safe to use and effective in eliminating harmful oral bacteria.
详细描述
After a dental implant procedure, implant stability is crucial for the success of the implant. The initial stability of the implant is determined by various factors such as implant design, surgical technique, bone quality, and quantity.
During the implant procedure, the implant is placed into the jawbone and is in direct contact with the surrounding bone. Over time, the bone will grow and fuse with the implant surface in a process called osseointegration. The implant stability is evaluated immediately after the surgery by measuring the implant stability quotient (ISQ) using a device called an implant stability meter.
The ISQ value ranges from 0 to 100, with higher values indicating greater implant stability. In general, an ISQ value of 60 or higher is considered to be a good indicator of implant stability. If the initial ISQ value is low, the implant may be at risk of failure due to lack of stability, and additional measures may be necessary to promote osseointegration, such as using bone grafting materials or growth factors.
In the first few weeks after the implant procedure, the implant may experience some initial mobility due to the inflammatory response and remodeling of the bone around the implant. However, with time, the bone will grow and fuse with the implant, providing a stable foundation for dental restoration.
With proper implant placement and regular follow-up care, the incidence of osteolysis can be minimized. Maintaining good oral hygiene practices, such as regular brushing, flossing, and dental check-ups, can help reduce the risk of inflammatory changes around dental implants. In addition, patients are usually advised to avoid placing excessive force on the implant during the healing process to prevent any damage to the implant and to ensure successful osseointegration. For example, patients can be advised to have a soft food diet at least for a few days after the 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
- Single (Outcomes Assessor)
盲法说明
Data will be collected using individual study codes for participants. Study codes do not reveal which group the participant has belonged to.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of ≥ 18 years
- •Generally healthy,
- •At least one new implant inserted
- •New implant inserted
- •Agreement to participate in the study with a written consent form signed
排除标准
- •Uncontrolled diabetes mellitus (DM)
- •Active smoking
- •Any significant systemic disease
- •Immediate implantation after tooth extraction
- •Use of antibiotics within 4 weeks week prior study
- •Presence of any physical limitation or restriction that might restrict Lumoral use
- •Pregnancy or lactation
- •History of six months use of antimicrobials, bisphosphonates, or corticosteroids.
研究组 & 干预措施
Study group
Standard oral hygiene and Lumoral Treatment home-use
干预措施: Lumoral Treatment (Device)
Study group
Standard oral hygiene and Lumoral Treatment home-use
干预措施: Standard oral hygiene (Other)
Control group
Standard oral hygiene only
干预措施: Standard oral hygiene (Other)
结局指标
主要结局
Incidence of osteolysis around dental implants
时间窗: 4 months
Assessing overall number of study subject that have developed osteolysis
次要结局
- Active matrix metalloproteinase 8 (aMMP-8)(4 months)
- Bleeding on probing (BOP)(4 months)
- Probing Pocket Depth (PPD)(4 months)