Soft Tissue Response to Different Restorative Materials Used in Implant Dentistry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid
研究概览
简要总结
The goal of this clinical trial is to learn how different materials used in dental implants affect the surrounding gum tissue in adults who need dental implants. The main questions it aims to answer are:
How do different materials (titanium, PEEK, zirconia, and lithium disilicate) affect inflammation around dental implants? What changes occur in inflammation markers in the gum tissue after 3 and 6 months? Researchers will compare the different materials to see which one causes the least amount of inflammation.
Participants will:
Receive dental implants made from different materials. Have samples of fluid from around their implants collected for analysis at 3 and 6 months.
Undergo regular dental check-ups to measure gum health, such as bleeding and pocket depth around the implants.
详细描述
The study will involve a total of 40 edentulous patients, each missing four teeth in the posterior region of the mandible or maxillae. Each patient will receive four dental implants and single crowns made from different materials. The primary objectives are to evaluate biomarkers in peri-implant crevicular fluid and to assess the changes in these biomarkers after three and six months of loading. This research will help determine the biocompatibility of the materials and their potential to cause peri-implantitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Participants must be 18 years or older.
- •Participants must be edentulous with at least four missing teeth in the posterior region of the mandible or maxillae.
- •Participants must have appropriate oral hygiene and periodontal status of natural teeth, with a pocket depth of 4mm or less and no bleeding.
- •Dental implants must be fully integrated with no bone resorption or inflammation after three months of implant placement, confirmed by X-ray and clinical examination.
- •Implant placement must be into natural bone without additional procedures such as sinus lift or bone augmentation.
- •The procedure must be a standard implantation with no immediate implant placement.
- •The height of the gingiva must be at least 3mm or more.
排除标准
- •Patients with systemic diseases such as malignancy, diabetes, osteoporosis, or rheumatoid arthritis.
- •Patients with a history of periodontal treatment.
- •Patients who smoke or use tobacco.
- •Patients who have received antibiotic treatment within three months prior to implantation.
- •Pregnant individuals.
结局指标
主要结局
Concentration of Inflammatory Biomarkers in Peri-Implant Crevicular Fluid
时间窗: 3 and 6 months post-implantation
The primary outcome measure will evaluate the concentration of inflammatory biomarkers in the peri-implant crevicular fluid, including IL-6, IL-8, IL-10, IL-17, TNF-alpha, IL-12, IL-1-beta, and IL-4. These biomarkers all have the same unit and will be measured to assess the inflammatory response of peri-implant soft tissue to different prosthetic materials (titanium, PEEK, zirconia, and lithium disilicate). The goal is to determine which material induces the least amount of inflammation, indicating better biocompatibility and a lower risk of peri-implantitis.
次要结局
- Clinical Measurements of Pocket Depth(3 and 6 months post-implantation)
- Clinical Measurements of Bleeding on Probing (BOP) and Pocket Depth(3 and 6 months post-implantation)
研究者
Samuel Akhondi
Research Associate
Harvard Medical School (HMS and HSDM)