MARGINAL BONE LEVELS AROUND IMPLANTS PLACED BY PARTIAL OR FULL-THICKNESS FLAP: A 3-YEAR RANDOMIZED CONTROLLED CLINICAL TRIAL
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- marginal bone levels
研究概览
简要总结
Each enrolled patient received one implant placed with the partial-thickness flap disconnect mode (PT Test Group) or the full-thickness flap disconnect mode (FT Control Group) from the same implant system (Anyridge, MegaGen Implant Co., Gyeongbuk, South Korea). Each implant was placed at 0.5 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature. This implant system has specific macrostructural and microstructural techniques that allow high levels of standards. The fixture-abutment connection is internally conical at 2.8 mm with 5° indexing: this feature makes it possible to reduce the prosthetic microgap, move the platform away from the bone margin while maintaining an optimal crestal margin and prevent rotation or unscrewing of the prosthetic component. Each implant was placed at 1 mm sub-crest as per protocol guidelines. This choice was made according to the current scientific literature.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 years of age;
- •Need for implant placement therapy in the posterior area (from the second premolar to the second molar) due to a failing tooth;
- •Presence of adjacent and opposing natural teeth;
- •Sufficient mesial-distal and interocclusal space for placement of the implant and definitive restoration;
- •Sufficient apical bone to achieve a minimum primary stability of 30Ncm.
排除标准
- •Diagnosis of periodontal disease;
- •Medical or general contraindications for the surgical procedure, such as systemic diseases, history of head and neck radiation therapy, current steroid treatment, neurological or psychiatric conditions affecting oral hygiene, immune-compromised status, severe clenching, or bruxism;
- •Heavy smoking (>10 cigarettes/day);
- •Active infection at the implant site.
研究组 & 干预措施
Implant placement through partial thickness flap procedure
干预措施: dental implants (Device)
Implant placement through full thickness flap procedure
干预措施: dental implants (Device)
结局指标
主要结局
marginal bone levels
时间窗: each year up to 3 years
次要结局
未报告次要终点
研究者
Antonino Palazzolo
DDS, MSc, MClindDent (Oral Surgery), PhD
University of Milan