Clinical Behavior and Patient Satisfaction of Zirconia-reinforced Glass-ceramic Crowns and Ultra-translucent-multilayered Monolithic Zirconia Crowns With a Conservative Marginal Design (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- clinical behavior
研究概览
简要总结
The aim of the present study is to evaluate clinical behavior and patient satisfaction of Zirconia-reinforced lithium disilicate press ceramic crowns when used in a conservative marginal design(0.6mm chamfer finish line). Comparison with Ultratranslucent multilayered monolithic zirconiacrowns will also be carried out in terms of marginal integrity, fracture, color stability and gingival health for 12 month
详细描述
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Select and examine patients based on inclusion/exclusion criteria, then obtain consent.
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Diagnose chief complaint, assess teeth in the esthetic zone, and perform scaling/polishing.
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Take primary impressions for study casts.
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Instruct patients to brush three times daily for good oral hygiene.
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Capture pre-op photos and radiographs.
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Choose the appropriate shade.
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Tooth Preparation:
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Group 1: Ultra-translucent zirconia crown (CAD/CAM, 0.6mm chamfer).
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Group 2: Zirconia-reinforced lithium disilicate crown (press, 0.6mm chamfer).
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Perform tissue retraction and take impressions with IOS.
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Create provisional crowns.
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Fabricate crowns (AMBRIA or KATANA zirconia) per manufacturer guidelines.
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Conduct try-in.
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Cement using light-cured resin adhesive.
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Assess restoration at 3, 6, 9 and 12 months for clinical behavior and patient satisfaction
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age range of the patients from 21- 50 years old; able to read and sign the informed consent document; illiterate patients will be avoided.
- •Patients who can physically and psychologically tolerate conventional restorative procedures.
- •Patients with endodontically treated teeth indicated for ceramic crowns in the esthetic Zone (all axial walls existing).
- •Patients with no active periodontal or pulpal diseases.
- •Patients with teeth problems indicated for full coverage restoration in the esthetic zone (e.g.
- •moderate to severe discoloration, coronal chipping where partial coverage would lack retention, malposed or malformed teeth).
- •Patients willing to return for follow-up examinations and evaluation.
- •Patients that care for good oral hygiene Maintenance.
排除标准
- •1 Patients with poor oral hygiene and motivation.
- •high caries rate.
- •Patients with psychiatric problems or unrealistic expectations (patient that has phobia from dental treatments or needle bunch).
- •Patients suffering from parafunctional habits or temporomandibular disorders.
- •7. Patients with teeth have extensive tooth structure loss, even if one wall is missing.
研究组 & 干预措施
UTML (KATANA) crowns arm
Patients will receive ultra-translucent multilayered monolithic zirconia crowns ( KATANA UTML) fabricated using CAD/CAM with conservative marginal design (0.6 mm).
干预措施: UTML (KATANA) crowns with conservative marginal design (Device)
ZLS crowns arm
Patients will receive zirconia-reinforced lithium silicate press ceramic crowns ( VITA Ambria) with conservative marginal design (0.6 mm).
干预措施: ZLS (AMBRIA) crowns with conservative marginal design (Device)
结局指标
主要结局
clinical behavior
时间窗: 12 months follow-up interval
Marginal integrity: Measuring device: Modified USPHS criteria. Measuring unit: Discrete (scores).
Fracture:
时间窗: Time Frame: 12 months follow-up interval.
Description: Measuring device: Modified USPHS criteria Measuring unit: Discrete (scores).
Color stability:
时间窗: Time Frame: 12 months follow-up interval
Description: Measuring device: Spectrophotometer Measuring unit: ΔE.
Gingival health:
时间窗: 12 months follow-up interval
Measuring device: Gingival index \& Bleeding on probing (BOP) Measuring unit: (scores).
次要结局
- patient satisfaction by Visual analogue Scale (VAS)(12 months follow-up interval)
研究者
Hanan Almudahka
Principal Investigator
Cairo University