Bioactive Microstructured Anti Microbial Precoated Surface Implant Versus Non-coated Surface Implant in Type 2 Diabetic Patients in the Mandible (Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- change in pain intensity
研究概览
简要总结
Dental implant's surface properties significantly influence both biological and mechanical integration. Surface bio-treatment could accelerate and enhance bone regeneration, ensuring successful implantation. therefore, this study compares bone densification, primary and secondary stability, wound healing, and pain intensity between pre-coated antimicrobial surfaces of dental implants versus non-coated surfaces in controlled type 2 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate interproximal space.
- •Adequate interocclusal space.
- •Adequate anatomical location, accessibility, and visualization for easy surgical implant placement.
- •Both genders.
- •Controlled medical condition
排除标准
- •Presence of parafunctional dependency as bruxism.
- •Adjacent pathosis near the implant site.
- •Patient under radiotherapy targeting the head and neck.
- •Heavy smokers.
研究组 & 干预措施
Pre coated surface implants
干预措施: Pre coated impants (Other)
Non coated surface implants
干预措施: Non coated implant surface (Other)
结局指标
主要结局
change in pain intensity
时间窗: 1st,3rd, and 7th days
pain was assessed using visual analogue scale that ranges from 0 (No pain) to 10 (untolerated pain)
Wound Healing score
时间窗: 1st,3rd, and 7th days,14th day
Landry healing index was used; 1. Very poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue:Present, Incision margin: Not epithelialized, with loss ofepithelium beyond incision margin, Suppuration: Present 2. Poor Tissue color: ≥50% of gingiva red, Response to palpation: Bleeding, Granulation tissue: Present, Incision margin: Not epithelialized, with connective tissue exposed 3. Good Tissue colour: ≥25% and\<50% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed 4. Very good Tissue colour: \<25% of gingiva red, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue exposed 5. Excellent Tissue color: All tissues pink, Response to palpation: No bleeding, Granulation tissue: None, Incision margin: No connective tissue expose
change in implant stability
时间窗: up to 4 months
implant stability will be assessed using Osstell device
次要结局
- Post operative complications(6 months)
- Change in bone density(up to 4 months)
研究者
Hams Hamed Abdelrahman
Assistant Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University