Effect of Customized Healing Abutments on Peri-implant Soft Tissue and Bone
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- soft tissue alteration
研究概览
简要总结
The goal of this clinical trial is to evaluate effect of customized healing abutment in patients who need single implant reconstruction. The main question it aims to answer is:
• effect of customized healing abutment on peri-implant soft and hard tissue Participants will received customized healing abutments before final prostheses delivery.
详细描述
Patients who need single implant restoration will be received one- stage implant placement with utilization of customized healing abutment. Data collection about change in hard and soft tissue will be collected digitally at several times points. Patients will received single crown on implant as final prosthesis. Change in peri-implant tissue will be analyzed with digital softwares.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18 years of age;
- •patients who needed a single implant placing therapy in maxillary or mandibular arch except in third molar regions
- •sufficient mesial distal and interocclusal space for placement of the implant and definitive restoration;
- •had sufficient apical bone to place an implant with minimum primary stability of 30 Ncm.
排除标准
- •medical and general contraindications for the surgical procedure;
- •heavy smokers (>10 cigarettes/day);
- •an active infection at the implant site.
结局指标
主要结局
soft tissue alteration
时间窗: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
peri-implant soft tissue change compared to baseline including vertical and horizontal soft tissue alteration by superimposing intraoral scan at different time points
hard tissue alteration
时间窗: T0 baseline before implant placement, 6month follow up, 12month follow up
peri-implant marginal bone change compared to baseline at different time points by periapical radiograph
volumetric alteration
时间窗: T0 baseline before implant placement,T1 1month follow up, 4month follow up, 6month follow up, 12month follow up
peri-implant volumetric change at different time points compared to baseline with superimposing intraoral scan
次要结局
- pain numerical rating scale(at prosthesis delivery, 2 hours and 24 hours after prosthesis delivery)
- pink esthetic score(T0 baseline before implant placement, 6 month follow up)
研究者
Pimduen Rungsiyakull
Associate Professor
Chiang Mai University