NCT07005167尚未招募不适用
Clinical Performance of Endocrowns Fabricated From Two Hybrid Ceramic Materials on Endodontically Treated Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Retention
研究概览
简要总结
The goal of this study is to evaluate the clinical success rate (measured by retention) of endo-crowns fabricated from two hybrid ceramic materials (HC Hard blocks ) versus (Cerasmart) at 6, 12, and 18 months.
Secondary Objectives are:
- To compare the incidence of restoration failures between the two materials
- To assess marginal adaptation and marginal discoloration over time
- To evaluate wear of opposing enamel quantitatively
- To compare surface texture, color match, and luster between materials
- To determine patient satisfaction with both types of restorations It will be a randomized, controlled, double-blind clinical trial with 1:1 allocation ratio.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years
- •Good general health (ASA I or II)
- •Willing and able to provide informed consent
- •Committed to follow-up appointments for 18 months
- •Root canal treated molars requiring restoration
- •Adequate remaining tooth structure:
- •Minimum 2mm ferrule height
- •Sufficient wall thickness (≥1.5mm)
- •At least 2 remaining walls
- •Opposing natural dentition or fixed prosthesis
- •Adequate periodontal health:
- •Probing depth ≤4mm
- •No bleeding on probing
- •Good oral hygiene with plaque score ≤20%
- •Sufficient mouth opening for clinical procedures
- •Normal occlusion and acceptable interocclusal space
排除标准
- •Pregnant or lactating women
- •Severe bruxism or parafunctional habits
- •Active periodontal disease
- •Active caries or inadequate oral hygiene
- •Less than 2mm ferrule height after preparation
- •Apical pathology or inadequate root canal treatment
- •Tooth mobility grade II or III
- •Known allergy to materials used
- •Uncontrolled diabetes (HbA1c >7.0%)
- •Radiation therapy in head and neck region
- •Temporomandibular joint disorders
- •History of poor compliance with dental appointments
- •Heavy smokers (>10 cigarettes/day)
- •Chronic use of medications affecting salivary flow
- •Unable to understand study requirements
- •Evidence of pulpal or periapical pathology
结局指标
主要结局
Retention
时间窗: From cementation of endocrown, then at 6 months, 12 months and 18 months
Modified USPHS criteria
次要结局
- Restoration Failure(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Marginal Adaptation(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Wear of Opposing Enamel(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Surface Texture(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Color Match(From cementation of endocrown, then at 6 months, 12 months and 18 months)
- Luster of Restoration(From cementation, then at 6 months, 12 months and 18 months)
- Patient Satisfaction(From cementation, then at 6 months, 12 months and 18 months)
研究者
Nada Ahmed Farid Zaki Shehab
Lecturer
Cairo University
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Clinical Performance of 3D-Printed vs. Milled EndocrownsNCT06850649Gulcan COSKUN AKAR33
已完成
不适用
Post root canal treatment restoration - Comparison between endocrown and fiber post crowCTRI/2019/04/018848I72
已完成
不适用
Clinical Evaluation of Endocrown and Overlay RestorationsClinical Performance of Endodontically Treated Teeth Restored With Endocrowns and OverlaysNCT06734806TC Erciyes University39
招募中
不适用
Digital, Conventional, And Biomimetic Approaches for Restoring Endodontically Treated TeethEndodontically Treated TeethNCT06717230October University for Modern Sciences and Arts42
进行中（未招募）
不适用
A 3-Year Clinical Evaluation Of Endocrown Restorations With Two Different MaterialsEndodontically Treated TeethNCT06311422Hacettepe University74