Clinical Evaluation of OBU When Used for Indirect Dental Restorations
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
研究概览
简要总结
The objective of this study is to evaluate the clinical safety and performance of Optibond Universal (OBU), a single component universal dental adhesive intended for indirect dental restorations according to manufacturer's Instruction For Use.
详细描述
The device used in the study, Optibond Universal (OBU) is a single component universal dental adhesive intended for direct and indirect dental restorations. OBU is formulated to provide reliable bond strength with any etch technique, on all common substrates and in combination with any resin cement without auxiliary products (silane or metal primers) even in absence of light. OBU is intended for general population use by a dental professional.
OBU contains an acidic component to etch the tooth surface in order to allow the adhesive to mechanically adhere to the prepared tooth surface. The adhesive can be used with light or without light cured prior to application of the restorative material. This allows for the adhesive to mechanically and chemically bond to the applied restorative material. OBU is formulated to provide a reliable bond strength, and it's compatible with all etching modes (self-etch, selective etch, and total etch).
Aim/Hypothesis/Objective The primary objective of this study is to evaluate the clinical performance of OBU used in the intended clinical conditions.
The device will undergo evaluation in the following categories:
Functional Properties Endodontic posts Ceramic restorations Composite and metal crowns Pretreatment for indirect restorations Core build-ups
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
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is willing to provide voluntary written informed consent in English.
- •Is in good medical health and able to tolerate the dental procedures.
- •Has 1 qualifying either vital or endodontically treated molar and/or premolar that requires an endodontic post and or core build-ups with subsequent indirect restoration or an indirect restoration only. Only 1 tooth per quadrant can be included in the study if more than 1 tooth in need of restoration. The maximum number of restorations will not exceed two per patient.
- •The tooth must be restorable, i.e. without subgingival caries and must have a minimum of 2-3 mm healthy supragingival tooth structure.
- •Study teeth must have an antagonist in the opposite jaw and have a neighboring tooth on at least one side.
- •Study teeth must be vital and without any symptoms suggesting irreversible damage of the pulp, or endodontically treated and hermetically filled according to standards of care (i.e., free of clinical signs and symptoms of periapical pathology).
排除标准
- •Is currently taking part in an evaluation of other dental procedures.
- •Has chronic periodontitis or rampant caries.
- •The study tooth exhibits clinical signs of periapical pathology.
- •The study tooth has a history of self-reported preoperative pulpal problems.
- •The study tooth that has been restored using eugenol containing materials.
- •Study Subjects with severe parafunctional habits or occlusal issues affecting the subject teeth.
- •Women who are pregnant (self-reported). It is standard of care to postpone routine dental procedures and radiographed until after pregnancy.
- •Women who are breast feeding.
- •Known allergy to methacrylates or other components of resin composites, local anesthetics, or metals used for dental restorations.
- •An employee of the sponsor or members of their immediate family.
- •Condition affecting salivary flow (e.g., salivary gland disorder, Sjögren's Syndrome, xerogenic medications).
- •Are unwilling or unable to have dental radiographs or photographs taken of their dentition and soft tissues.
- •Unable to return to the recall visits.
- •Any other condition which is the view of the investigator may affect the ability of a patient to complete the study.
- •Teeth with implant restorations.
- •Third molars.
结局指标
主要结局
Sensitivity Questionnaire-Visual Analog Scale 1 to 5 (1=No pain, 5=Worst pain possible)
时间窗: 2-Year Followup Assessments (approximately 2 years from Baseline)
Postoperative sensitivity
FDI (World Dental Federation) Clinical Evaluation Criteria-Modified
时间窗: 2-Year Followup Assessments
Functional Properties, Biological Properties, Aesthetic Properties (1 clinically excellent-5 clinically poor Scale)
Sensitivity Questionnaire-Visual Analog Scale 0 to 10 (0=No pain, 10=Worst pain possible)
时间窗: 48 hours after Cementation (up to 4 weeks from Preparation)
Postoperative sensitivity
次要结局
未报告次要终点
研究者
Sibel Antonson
Professor and Assistant Dean for Research and Development
Nova Southeastern University