Evaluation of the Effect of Slopped Shoulder Implant Neck Versus Conventional Implant Neck Design on the Crestal Bone Level in the Maxilla: Randomized Clinical Trial (RCT)
试验速览
- 阶段
- 不适用
- 入组人数
- 16
- 主要终点
- pink esthetic score(PES)
研究概览
简要总结
In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching.The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues.
详细描述
Implant prosthesis allows normal muscle function, and the implant stimulates the bone and maintains its dimensions in a manner similar to healthy natural teeth. Crestal bone loss can result in increased bacterial accumulation resulting in secondary peri-implant inflammation and bone loss which can further result in loss of alveolar support, which in turn can lead to occlusal overload resulting in implant failure. In implant dentistry, platform switching is a method used to preserve alveolar bone levels around dental implants. The concept refers to using an implant with slopped shoulder neck of narrower diameter on implants of wider diameter, rather than placing abutments of similar diameter, referred to as platform matching. The authors developed the concept of slopped shoulder implant which results in an inward bone creeping at the coronal part of the implant to be in continuity with the alveolar bone crest.
The rational to use this type of implant allows an increase at residual crestal bone volume around the implant neck and has 3 merits:
- Reduced mechanical stress at the implant neck area;
- Repositioning of gingival papillae on the beveled neck implant (that is the physiologic condition);
- proper vascular supply to the implant investing structure and bone tissue also because of reduced inter-implant space.
The aim of the study is to compare the effect of bone-level implants versus the conventional implant on oral soft tissues
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
the design of the dental implant
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good oral hygiene
- •Systemically healthy (free from any systemic diseases).
- •Adequate native bone to achieve implant primary stability
- •Have had the tooth extraction at least 3 months before implant surgery.
- •Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery
排除标准
- •Pregnant woman
- •Had a history of alcoholism or drug abuse within the past 5 years.
- •Had bruxism or clenching habits.
- •Patients who refused to join the study.
- •Had significant untreated periodontal disease or history of treated periodontitis.
- •Had caries on teeth adjacent to the prospective implant site.
- •Periapical infection.
- •localized radiation therapy of the oral cavity; antitumor chemotherapy.
- •poor oral hygiene
研究组 & 干预措施
slopped shoulder implant
The osteotomy site will be prepared using appropriate drill sizes with flapless approach, The implant (conventional neck implant design )will be inserted till the platform will be flushed with the crestal bone, The primary stability will be checked using torque wrench
干预措施: slopped shoulder implant (Other)
conventional implant with flat platform
inserted implant will be bone leveled implant (crestal maxi z) implant (conventional implant with platform). The primary stability will be checked using torque wrench
干预措施: slopped shoulder implant (Other)
结局指标
主要结局
pink esthetic score(PES)
时间窗: 8 months
soft tissue esthetics scale : Seven variables will be evaluated vs. a natural reference tooth: mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. Using a 0-1-2 scoring system, 0 being the lowest, 2 being the highest value, the maximum achievable PES is 14.
次要结局
- crestal bone resorption(8 months)
- implant stability(8 months)
研究者
Hosam Ahmed Sharawi Shehabeldin
B.Sc. in Oral and Dental Medicine
Cairo University