Comparison of Two Different Excess Cement Clean-up Options for Cementing Metal-free Ceramic Restorations on Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Relative ratio between the detectable area covered by cement remnants per crown site and the total crown
研究概览
简要总结
This study quantitatively compared cement residues of two resin cement types around implant-supported restorations (ISR) with a crown-abutment margin located at the gingival level. This prospective, single-blinded, cross-over clinical trial compared optically detectable cement remnants between Self-Adhesive Resin Cement (RC) and Resin-Modified Glass Ionomer Cement (RMGIC).
详细描述
This prospective, two-arm, non-randomized, clinical trial compared detectable cement remnants on 30 patients and 60 ISR. Two cements were compared; self-adhesive resin (RC) and resin-modified glass ionomer (RMGIC). Comparisons were carried out on identical pairs of ISR tested within the same patients with a 1-week healing interval. The primary outcome variable was the ratio of cement-covered area to total crown area. Areas were analyzed ex-situ by standardized digital image analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •physical and psychological ability to undergo implant therapy (ASA I or II)
- •presence of a single mandibular molar indicated for extraction with adjacent healthy and present natural teeth or implant-supported restoration
- •presence of ≥ 6 mm width and ≥ 10 mm height native bone ridge - presence of intact alveolar bone walls after tooth extraction and presence of interradicular bone > 4 mm to achieve primary implant stability
- •presence of ≥ 1.5 mm distance to adjacent teeth at the bone level
- •overall healthy, non-inflamed keratinized soft tissues.
排除标准
- •Presence of general conditions contributory to dental implant treatment comprising but not limited to:
- •presence of active periodontitis 25
- •poor oral hygiene as determined by the Oral Health Index (OHI)
- •pregnant or lactating
- •presence of uncontrolled medical systemic conditions, e.g. diabetes;
- •ongoing or past medical treatments affecting wound healing, terminated less than 3 months prior to the study-related intervention
结局指标
主要结局
Relative ratio between the detectable area covered by cement remnants per crown site and the total crown
时间窗: Crowns were retrieved for analysis immediately after intraoral cementation and residual cement removal.
Digital photographs of the specimens were obtained using custom-made equipment with a standardized distance. The images were analyzed as follows: the contours of the area covered by residual cement were identified visually after optical magnification and marked; the contours comprising the entire surface area of the prosthetic superstructure, i.e. abutment and crown, were determined; the ratio between the area covered with cement and the total surface area per aspect of the specimen was calculated.
次要结局
未报告次要终点