Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Survival rate of zirconia RBFDPs
研究概览
简要总结
The purpose of this study is to evaluate the clinical outcome of resin-bonded fixed dental prostheses (RBFDPs) pretreated with nanostructured alumina coating (NAC).
The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) (control) as a surface pretreatment method of zirconia RBFDPs used for replacing missing central or lateral incisors. The primary outcome evaluated is the retention/survival of the zirconia RBFDPs pretreated with APA and NAC.
详细描述
Zirconia resin-bonded fixed dental prostheses (RBFDPs) have been regarded as a promising minimally invasive alternative for the replacement of missing central and lateral incisors, offering several advantages to orthodontic space closure or tooth replacement with implant-supported restorations. Debonding of the zirconia RBFDPs represents the main technical complication since clinically established airborne particle abrasion (APA) of an inert zirconia surface does not always provide sufficient resin-bond strength. Further, APA can also impair the mechanical properties of zirconia restoration affecting its long-term success. Nano-structured alumina coating (NAC) presents an alternative non-invasive zirconia surface pretreatment. The aim of this randomized controlled clinical trial is to study the effect of NAC coated bonding surface of zirconia RBFDPs affecting its debonding and clinical survival rate.
The study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) as a surface pretreatment method of zirconia RBFDPs. Healthy patients in need of a missing central or lateral incisor replacement are screened and rated to be eligible by two calibrated dentists. RBFDPs are randomly allocated into two groups and inserted by the same operator. The first group, where the bonding surface is pretreated with APA serves a control group. In the second group the restorations are pretreated with NAC. The participants and the operator are blinded to the group assignment in a double-blinded trial design. The primary outcome evaluated is the retention/survival of the RBFDP. Non-parametric tests and Kaplan-Meyer analysis will be used to determine differences between both study groups.
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)
盲法说明
Prior to the beginning of the study 50 identification numbers were divided into 2 groups on the basis of a computer generated tables (www.randomization.com). The two groups were then randomly allocated to the zirconia pretreatment method using a random generator. The randomization process was conducted by a staff member not involved in the research protocol. For each identification number, the selected pretreatment is written on a card contained in an opaque sealed envelope. The envelopes are stored by a study supervisor. Each envelope is opened by a dental technician after the RBFDP's zirconia framework is milled and then once again stored by the study supervisor until the conclusion of a study.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1. Patients with missing central or lateral incisor
排除标准
- •inadequate edentulous space for the pontic
- •signs of bruxism
- •abutment tooth with active periodontal or periapical disease
- •inadequate enamel bonding surface of the abutment tooth
- •inadequate interocclusal space for a retainer wing and a proximal connector
- •pontic guidance
- •physical or psychological disease likely to interfere with normal conduct of the study
研究组 & 干预措施
NAC
Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework
干预措施: NAC (Other)
APA
Air-borne particle abrasion of zirconia RBFDPs prior to bonding
干预措施: APA (Other)
结局指标
主要结局
Survival rate of zirconia RBFDPs
时间窗: From baseline through study completion, an average of 1 year
Survival rate is defined by debonding or restoration loss
次要结局
- Gingivitis(From baseline through study completion, an average of 1 year)
- Parodontitis(From baseline through study completion, an average of 1 year)
- Zirconia framework fracture(From baseline through study completion, an average of 1 year)
- Marginal leakage(From baseline through study completion, an average of 1 year)
- Secondary caries(From baseline through study completion, an average of 1 year)
- Porcelain chipping(From baseline through study completion, an average of 1 year)