Clinical Evaluation of Lava Digital Veneer System (DVS) Crowns
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria
研究概览
简要总结
Study aim is to compare Lava Computer Aided Design / Computer Aided Milling Computer Aided Machining (CAD/CAM)crowns that are veneered (covered) with porcelain that has been milled using CAD/CAM, with similar CAD/CAM Lava crowns that have been veneered with a hand fabricated porcelain covering.
详细描述
Veneers will be randomly allocated to study crowns. Study crowns will be evaluated over three years. The test porcelain veneer is CAD/CAM milled as a veneer shell that is then fused to the CAD/CAM milled Lava crown to make the final crown to be cemented in the patient's mouth. This may be a more predictable technique in the fabrication of Lava crowns than current conventional methods.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 18 years of age.
- •Have at least one decayed back tooth in need of a crown
- •Study tooth to be an upper or lower premolar or molar tooth/ teeth
- •Study tooth to be vital and asymptomatic at start of study
排除标准
- •Teeth which are non vital, have had root canal treatment
- •Teeth which are pulp capped
- •Sensitive teeth
- •Significant untreated dental disease including periodontitis and rampant decay
- •Pregnant or lactating women
- •Patients with allergies to any of the materials to be used in the study
- •Unable to attend the recall appointments
研究组 & 干预措施
DVS veneer
veneer made by CAD/CAM method
干预措施: DVS veneer (Device)
Conventional veneer
Veneer made by laboratory technician
干预措施: Conventional Veneer (Device)
结局指标
主要结局
Clinical Performance of Crowns Via Modified United States Public Health Service (USPHS) Criteria
时间窗: 1 year
Performance reported as the % of teeth with perfect (alpha/A) scores. USPHS criteria: Color Match ( A=Ideal, B=perceptible mismatch but acceptable, C=obvious mismatch and unacceptable); Margin Adaptation (A=no visible crevice, B=crevice along \<50% margin\>1mm depth, C=crevice along\>50% margin \>1mm depth); Margin discoloration (A=none, B=Surface stain non penetrating, C=Penetrating; Surface Finish (A=smooth, B=moderately uniformly rough, C=significant pitts/voids; Crown Fracture (A=none, B=small but repairable, C= coping exposed/complete delamination; Proximal Contact (A=firm resistance to floss/ideal contact, B=light resistance/variable breadth, C=open; Sensitivity (A=none, B= slight but not uncomfortable, C=severe; Caries (A=no evidence, B= evident but repairable, C=evident/not repairable.
Gingival/Periodontal Health Based on Loe & Stillness Index, 1963.
时间窗: 1 year
Performance reported as the # of crowns exhibiting 0, 1, 2 and 3 index score. Gingival Index (0=normal, 1=mild inflammation, 2=moderate inflammation, 3=severe inflammation. Plaque Index (0= none, 1= observed only via probe at on tooth surface at gingival crest, 2=moderate accumulation along gingival margin and adjacent tooth, 3= abundant plaque along gingival margin and adjacent tooth.
次要结局
未报告次要终点