Effect of Adding Silicon Dioxide (SiO₂) Nanoparticles to a Printable Acrylic Resin Denture Base Material for Implant Overdentures: A Clinical Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Surface Roughness of the Denture Base Fitting Surface
研究概览
简要总结
This clinical study evaluated whether adding a small amount (0.5 wt%) of silicon dioxide (SiO₂) nanoparticles to a 3D-printable acrylic denture material could improve the clinical performance of implant-retained mandibular overdentures.
the results showed that the SiO₂-modified denture bases had smoother surfaces and were associated with better peri-implant soft tissue measurements than the conventional 3D-printed denture bases. The modified denture bases also showed lower bacterial counts and reduced Candida albicans levels during follow-up. No implant failures were reported during the study period.
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
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dentally Edentulous Status: Completely edentulous patients in both arches requiring a maxillary complete denture and a mandibular implant-retained overdenture.
- •Bone Volume: Patients with adequate mandibular bone height and width to accommodate bilateral implant placement in the canine region.
- •General Health: Good general health status permitting standard dental implant surgical procedures.
- •Oral Hygiene: Acceptable oral hygiene status and motivation to maintain oral health.
- •Compliance: Patient willingness and capability to comply with all scheduled follow-up visits and clinical evaluations.
排除标准
- •Systemic Health Conditions: Patients with compromised systemic conditions or uncontrolled systemic diseases that adversely affect bone healing, soft tissue response, or osseointegration (e.g., uncontrolled diabetes mellitus).
- •Oncological Therapy: History of previous head and neck radiotherapy or active/past chemotherapy.
- •Tobacco Use: Heavy smoking
- •Parafunctional Habits: Presence of severe bruxism or other parafunctional oral habits.
- •Patient Compliance: Poor patient compliance or inability/unwillingness to commit to the required follow-up schedule and maintenance protocols.
研究组 & 干预措施
Conventional 3D-Printed Denture Base
Completely edentulous patients receiving two-implant-retained mandibular overdentures fabricated using standard, unmodified 3D-printable acrylic resin.
干预措施: Standard 3D-printed acrylic resin denture base (Device)
SIO2 Nanoparticle-Modified 3D-Printed Denture Base
Completely edentulous patients receiving two-implant-retained mandibular overdentures fabricated using 3D-printable acrylic resin modified with $0.5 wt% silanized silicon dioxide SiO2 nanoparticles.
干预措施: SIO2 nanoparticle-modified 3D-printed acrylic resin denture base (Device)
结局指标
主要结局
Surface Roughness of the Denture Base Fitting Surface
时间窗: Baseline (denture insertion), 3 months, and 6 months post-insertion
Measured in micrometers using a 3D optical profilometer to assess surface micro-irregularities. Standardized areas on both the right and left sides of the denture base fitting surface are evaluated to calculate the mean value. Lower values indicate a smoother surface.
次要结局
- Candida albicans Colony Count(1 week, 1 month, 3 months, and 6 months post-denture insertion)
- Modified Gingival Index (GI)(1 month, 3 months, and 6 months post-denture insertion)
- Modified Plaque Index (PI)(1 month, 3 months, and 6 months post-denture insertion)
- Modified Probing Depth (PD)(1 month, 3 months, and 6 months post-denture insertion)
- Aerobic Bacterial Count(1 week, 1 month, 3 months, and 6 months post-denture insertion)