Biological and Esthetic Evaluation of Ceramic Onlay With Different Preparation Designs (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- postoperative sensitivity
研究概览
简要总结
Aim of study: is to asses biological and esthetical success of ceramic onlay restorations while preparing the teeth using shoulder finish line preparation versus butt joint with bevel preparation.
Methods:
Patients with need to posterior onlay restoration (premolars and molars) will be allocated into two groups either conventional (shoulder finish line) or conservative group (butt joint with bevel), after tooth preparation impression, restoration fabrication, try in, cementation and restoration will be evaluated two weeks post cementation then follow up will be held every two months for 1 year.
详细描述
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Research objective: The aim of this study is to asses biological and esthetical success of ceramic onlay restorations while preparing the teeth using shoulder finish line preparation versus butt joint with bevel preparation.
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Research Procedure:
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Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radiographic examination, intraoral photographs and primary impression (alginate impression*) for diagnostic cast construction.
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Visit 2: Tooth preparation according to its group either shoulder, or butt joint with bevel preparation, secondary impression using addition silicone rubber base material two step two viscosities technique and temporary restoration.
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Visit 3: evaluation of e-max press onlay ceramic restoration on the cast then evaluation intra-oral on the prepared tooth and permanent cementation of the final restoration using adhesive resin cement.
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Visit 4: Every 2 months post operatively follow-up visit for one year.
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PICOTS P: Population: Patients requiring posterior onlays. I: Intervention: butt joint finish line with bevel preparation for ceramic onlay.
C: comparator: shoulder finish line preparation for ceramic onlay.
O: Outcome:
Primary: Postoperative sensitivity Secondary: Marginal discoloration Tertiary: Secondary Caries T: Time: 1 year. S: Study design: Randomized controlled clinical trial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double blinded
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1-From 18-70 years old, be able to read and sign the informed consent document.30 2- Have no active periodontal or pulpal diseases, have teeth with good restorations.
- •3- Psychologically and physically able to withstand conventional dental procedures 4- Patients with teeth problems indicated for posterior onlay (molars or premolars).
- •Decayed teeth
- •Teeth restored with large filling restorations 5- Able to return for follow-up examinations and evaluation
排除标准
- •Patient less than 18 or more than 70 years
- •Patient with active resistant periodontal diseases
- •Patients with poor oral hygiene, high caries risk and uncooperative patients
- •Pregnant women
- •Patients in the growth stage with partially erupted teeth
- •Psychiatric problems or unrealistic expectations
- •Lack of opposing dentition in the area of interest. 8- the presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region.
研究组 & 干预措施
conventional ceramic onlay with shoulder finishline
tooth that need ceramic onlay restoration, a conventional cavity will be prepared with shoulder finishline.
干预措施: shoulder finishline (Procedure)
conservative ceramic onlay preparation buttjoint with bevel
tooth that need ceramic onlay restoration, a conservative cavity will be prepared with butt joint with bevel finishline.
干预措施: butt joint with bevel (Procedure)
结局指标
主要结局
postoperative sensitivity
时间窗: 1 year follow up
pain immediately after restoration cementation
次要结局
- Marginal Discoloration(1 year follow up)
研究者
Ahmed Adel Mahmoud Gadallah
PhD researcher
Cairo University