Clinical Performance and Patient Satisfaction of Cerasmart Versus Lithium Disilicate (E-max) Endocrowns of Endodontically Treated Molar Teeth
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Color match
研究概览
简要总结
- RATIONALE All-ceramic endocrowns are bonded to the tooth using adhesive resins creating strong bonds to the tooth structure resulting in strengthening effect and reducing the need for post and core. various CAD/CAM materials can be used for the fabrication of endocrowns including lithium-disilicate reinforced glass-ceramics, feldspathic ceramics, in ceram alumina and in ceram spinell as well as hybrid ceramics and composites.
Fewer data are available on the clinical performance of the different materials used for endocrowns. With the rapid innovation in the dental restorative materials clinicians are sometimes confused when selecting the best restorative material to restore an endodontically treated tooth with an endocrown. This is due to lack of data with regard to clinical performance of these restorations as well as the degree of patient satisfaction. 2. OBJECTIVES P= Endodontically treated teeth indicated for endocrown I1= Feldspathic endocrown I2= Hybrid endocrown C= IPS e.max Endocrown O= Clinical performance
Research question In patients with endodontically treated teeth requiring endocrown restorations, what are the clinical performance and the level of patient satisfaction of cerasmart endocrown versus lithium disilicate (e-max) ceramic endocrowns?
详细描述
Administrative information
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Title: Clinical performance and patient satisfaction of cerasmart versus lithium disilicate (e-max) endocrowns of endodontically treated teeth (Randomized Controlled Clinical trial) 2. Trial registration: This study will be registered on Clinicaltrials.gov. 3. Protocol version: Version (1). 4. Funding: The trial is totally self-funded whether on a financial or a non-financial basis. Department of fixed prosthodontics, Faculty of Oral and Dental Medicine, Cairo University, provides equipment units and some consumables.
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Roles and responsibilities 5.a. Name: Moustafa Maher Moustafa Elbehairy (E.M). Rule: (Main researcher*)
*Responsible for all clinical procedure in this clinical trial and measuring different outcomes for each group.
Affiliation: Master of Science of Fixed Prosthodontic department-Cairo University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range of the patients from 15-60 years old.
- •Patients able physically and psychologically to tolerate conventional restorative procedures.
- •Patients with endodontically treated molars.
- •Patients with adequate root canal treatment with good apical seal.
- •Presence of teeth in opposite arch with normal occlusion.
- •Supra-gingival margin after preparation.
- •One wall defect cavity.
- •Patients willing to return for follow-up examinations and evaluation.
排除标准
- •Patients in the growth stage with partially erupted teeth.
- •Patients with poor oral hygiene and motivation.
- •Patients with parafunctional habits.
- •Patients with active periodontal or periapical disease.
结局指标
主要结局
Color match
时间窗: 6 months
Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.
Retention
时间窗: 6 months
Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.
Marginal discoloration
时间窗: 6 months
Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.
Secomdary caries
时间窗: 6 months
Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.
Surface texture
时间窗: 6 months
Modified USPHS
Marginal adaptaion
时间窗: 6 months
Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.
Anatomic form
时间窗: 6 months
Modified USPHS Primary outcome: the two groups will be assessed using the modified United States public health service (USPHS) criteria as follows * Alpha (Excellent) ideal. * Bravo (Acceptable) less than ideal but no modifications required * Charlie (Acceptable but modifications needed) staining or other shade modifications required. All the grades of all the patients in both groups will be collected (for the alpha, bravo and Charlie) and the scores for the modified gingival index and the gingival periodontal index and aggregation will be done for the results. For the clinical performance outcome, aggregates of all the alpha grades will be grouped as well as for the bravo and Charlie grades, then a percentage will be calculated for each grade.
次要结局
- Modified Periodontal Index(6 months)
- Modified Gingival bleeding index MGI(6 months)
- Patient satisfaction(6 months)
研究者
Moustafa Elbehairy
PhD Student
Cairo University