Evaluation of Low-Intensity Therapeutic Wavelength Nanotechnology Devices in Alveolar Preservation: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- VAS
研究概览
简要总结
After tooth extraction, a progressive alveolar bone resorption is observed. Alveolar ridge preservation consists of placing a biomaterial within the extraction socket and covering it with a membrane.
This procedure helps limit physiological bone resorption, making the soft and hard tissue profile of the edentulous site more prosthetically favorable.
详细描述
After tooth extraction, a progressive remodeling process occurs that is often associated with significant alveolar bone resorption, particularly in sites with compromised bony walls. Alveolar ridge preservation is a surgical procedure aimed at minimizing this physiological resorption by placing grafting materials within the extraction socket and protecting them with a barrier membrane.
In the present protocol, the socket is filled with a xenogeneic bone graft enriched with hyaluronic acid, which enhances biological activity by promoting angiogenesis, cell migration, and early wound healing. The grafted site is then covered with a dermal matrix membrane, providing mechanical protection, stabilization of the biomaterial, and guided tissue regeneration.
In one study group, in addition to the surgical procedure, postoperative biostimulation using low-intensity photonic nanotechnology is applied. This adjunctive therapy is intended to enhance cellular metabolism, modulate inflammation, and accelerate both soft and hard tissue healing. The combined approach aims to preserve alveolar volume more effectively, improve the quality of regenerated tissues, and create a more favorable prosthetic environment for subsequent implant rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 21 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults in good general health
- •Indication for tooth extraction in sites planned for delayed implant placement
- •Inability to place immediate post-extraction implants due to insufficient residual bone to ensure primary stability
- •Extraction sockets presenting absence of the buccal (vestibular) bone wall
- •Signed informed consent
排除标准
- •Systemic conditions affecting bone healing
- •Uncontrolled periodontal disease
- •Smoking >10 cigarettes/day
- •Pregnancy or lactation
- •Use of medications interfering with bone metabolism
研究组 & 干预措施
Traditional Alveolar Preservation
The socket is filled with a xenogeneic bone graft enriched with hyaluronic acid and dermal membrane
干预措施: Socket Preservation (Procedure)
therapeutic wavelengths Alveolar Preservation
Therapeutic wavelengths are applied as part of the alveolar preservation protocol. The extraction socket is filled with a xenogeneic bone graft enriched with hyaluronic acid and subsequently covered with a dermal membrane to support healing and tissue regeneration.
干预措施: Socket Preservation (Procedure)
结局指标
主要结局
VAS
时间窗: 1 day , 3 days , 7 days ,14 days
Postoperative pain assessment using the Visual Analog Scale (VAS) (1-10)
Analgesic consumption
时间窗: 7 days
recorded as the number of ibuprofen 400 mg tablets taken
次要结局
- Histological Evaluation(4- 6 month)
研究者
Giuseppe D'Albis
Dr
University of Bari Aldo Moro
