Comparison of the Short-term Clinical Efficacy of Angulated Screw-retained and Cemented Single Implant Crowns in Esthetic Region: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Marginal bone loss
研究概览
简要总结
Objective: To compare the clinical efficacy of angulated screw-retained and cemented single implant crowns(SIC) in esthetic region.
Methods/Design: The study was a prospective, single center, randomized controlled clinical trial. Patients with the needs of single tooth restoration in esthetics region were recruited from Oct. 2018 to Aug. 2019. Sixty patients were enrolled in the present study and they were randomly assigned into two groups: angulated screw-retained group(AG, 30 patients) and cemented group (CG,30 patients). Clinical and radiological evaluations were performed on the day of final crowns delivery and 12 months later. Implant survival rate, marginal bone loss(MBL), pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)(TNF-α, IL-6), mechanical complications, peri-implant conditions(mPI, PD, BOP%), pink esthetics score/white esthetics score (PES/ WES) and patients satisfaction were assessed.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1) age≥18;
- •2) Single dental implant in the esthetic region;
- •3) adjacent to natural teeth;
- •4) absence of oral mucosal disease and oral infection;
- •implants withconical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
- •patients with the willingness of all-ceramic permanent restorations.
排除标准
- •Multiple implants in the esthetic region, or the restoration is a bridge;
- •Heavy smokers (>10 cigarettes/day);
- •3) the angle between implant axis and restoration axis>25°;
- •4) uncontrolled periodontitis;
- •5) with systematic diseases that may affect implant therapy, such as uncontrolled diabetes mellitus (Fasting blood-glucose>7.2mmol/L, Glycosylated hemoglobin >7%), current intake of bisphosphonates (treatment for malignancy), pregnant(or plan to get pregnant), with history of radiation therapy in head and neck region;
- •6) Unwilling to participate in the present study.
结局指标
主要结局
Marginal bone loss
时间窗: 1year
Peri-apical radiographs with paralleling technique wereperformed on the day offinal restorations delivery and 1-year visit. Implant length was used as calibration reference. The distance between restoration margin and the most coronal level of implant-bone contactwas recorded. Final result was calculated as themean value of the mesial and distal sites
次要结局
- Survival rate.(1 year)
- Mechanical complications(1 year)
- PES/WES(1 year)
- Patient's satisfaction(1 year)
- bleeding on probing% (BOP%)(1 year)
- Pro-inflammatory cytokinesin peri-implant crevicular fluid (PICF)(1 year)
- pocket probing depth(PD)(1 year)
- modified plaque index (mPI)(1 year)
研究者
Junyu Shi
Principal Investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University