Comparison of BioHPP (High Performance Polymer) - vs Titanium- vs Zirconia Abutments A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean Bone level
研究概览
简要总结
The project is a prospective, randomized, controlled study. The material BioHPP (High Performance Polymer) is compared with the gold-standard abutment materials titanium and zirconia in terms of peri-implant soft tissue healing.
详细描述
A total of 60 participants are divided into three groups of 20 persons each. One group receives BioHPP abutments, while the two control groups receive titanium or zirconia abutments.
The patients are provided with closed healing dental implants. After 3 months, following implant exposure and optical impression, the implants are restored with individual abutments.
Follow-up appointments are scheduled at 3, 6, 12, 24, and 36 months after implantation. During these visits, implant healing is assessed based on clinical parameters such as probing depth, plaque index, mean bone level, and bleeding on probing.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •The patients must be between 18 and 99 years old.
- •non-smokers, former smokers, or light smokers (fewer than 10 cigarettes per day).
- •ASA ( American Society of Anesthesiologists) Class I or II.
- •There must be no pregnancy or breastfeeding period.
- •the patients must have an edentulous section of up to 3 teeth in the maxillary or mandibular region, where it is possible to place an implant
- •no allergy to any of the study-related materials
排除标准
- •Patients under 18 or over 99 years old.
- •Heavy smokers or former heavy smokers who quit less than five years ago
- •Existing pregnancy or breastfeeding period.
- •Individuals classified as ASA Class III to V.
- •Presence of a polymer allergy.
- •Patients with severe systemic diseases, immune deficiencies, or on corticosteroid medication.
- •Patients undergoing local radiation or bisphosphonate therapy.
- •Patients requiring sinus augmentation or soft tissue augmentation.
- •Participation in another dental study
结局指标
主要结局
Mean Bone level
时间窗: 36 months after implantation
in millimeters
次要结局
- Plaque index(36 months after implantation)
- Bleeding on probing(36 months after implantation)
- Probing depth(36 months after implantation)
- Occurrence of complications(36 months after implantation)