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临床试验/NCT07648485
NCT07648485尚未招募不适用

Clinical Performance of CAD/CAM Hard Hybrid Ceramic Inlays Versus Resin Composite Inlays in Vital Molars With Extensive Occluso-Proximal Cavities: Two-Year Randomized Clinical Trial

Cairo University0 个研究点目标入组 50 人开始时间: 2026年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Marginal Adaptation

研究概览

简要总结

this study aims to compare the clinical performance of hard hybrid ceramics and composite resin indirect restorations fabricated by CAD/CAM technology for the vital teeth with occluso-proximal cavities. the clinical performance assessed include marginal adaptation primarily and in addition to Color match, marginal discoloration, aesthetic anatomic form, recurrent caries and restoration fracture and post-operative hypersensitivity. the clinical performance will be assessed after the restoration cementation, after 6, 12, 18 and 24 months.

详细描述

A wide variety of materials is now available for the fabrication of indirect restorations used to manage extensive carious lesions, including high-strength ceramics, hybrid ceramics, and resin-composite blocks. Each material offers distinct advantages in strength, wear resistance, aesthetics, and bonding performance, thereby expanding treatment options for severely compromised posterior teeth. However, these differences in mechanical and optical behavior, marginal adaptation, and long-term durability under functional stresses complicate clinical material selection.

Limited data is available comparing the clinical performance of these materials, particularly in large cavities in these regions. More information is needed on how they prevent post-treatment sensitivity, maintain edge quality, and resist discoloration, wear, and fractures.

Though short-term studies indicate excellent survival rates and aesthetic results for CAD/CAM hybrid ceramic inlays (more than 90% survival after two years), and systematic reviews imply that CAD/CAM resin composite inlays match ceramic restorations (success rates ranging from 85.7% to 100% for composites versus 93.3% to 100% for ceramics). There is a lack of direct clinical comparisons between these two material types in vital molars with occluso-proximal cavities. Much of the existing research is constrained to onlay designs or mixed-material groups, creating a significant gap in understanding which CAD/CAM block type delivers superior long-term performance for inlay restorations in vital teeth.

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
Single (Outcomes Assessor)

入排标准

年龄范围
16 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Systematically healthy male or female subjects aged 16 to 50 years.
  • Patients with good oral hygiene.
  • Presence of a single vital molar with coronal destruction due to caries, defined as radiographic evidence of caries involving more than 50% of the total dentin thickness with loss of at least one proximal wall.
  • Cavitary preparation involving loss of at least one proximal walls (mesial and/or distal), with intact buccal and lingual walls, and all cavosurface margins located in enamel.
  • Presence of functional opposing teeth in stable occlusion

排除标准

  • Presence of systemic diseases (e.g., uncontrolled diabetes, immune disorders).
  • Current pregnancy or lactation.
  • Documented allergy to resin-based composites or adhesive systems.
  • Evidence of pulpal necrosis or previous endodontic treatment in the target tooth.
  • Presence of cracks or fractures involving the tooth structure.
  • Active localized or generalized periodontal disease.
  • Evidence of parafunctional habits, including bruxism or clenching.
  • High caries risk.

研究组 & 干预措施

Hybrid ceramic group

Experimental

indirect restoration (inlay design) using CAD/CAM Fabricated Hard Hybrid Ceramic blocks

干预措施: hybrid ceramics (Other)

Composite Resin group

Active Comparator

indirect restoration (inlay design) using CAD/CAM Fabricated from Composite Resin Blocks

干预措施: Composite resin (Other)

结局指标

主要结局

Marginal Adaptation

时间窗: -baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation

measured using modified United States Public Health Service (USPHS) criteria scored as Alpha, Bravo, Charlie, Delta (Alpha score is the best and Delta is the worst).

次要结局

  • color match(-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation)
  • marginal discoloration(-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation)
  • aesthetic anatomic form(-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation)
  • recurrent caries(-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation)
  • restoration fracture(-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation)
  • Post-operative hypersensitivity(-baseline (after the restoration cementation) -6 months after restoration cementation -12 months after restoration cementation -18 months after restoration cementation -24 months after restoration cementation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sayed Ahmed Sayed Karim

PhD Student at Department of Conservative Dentistry

Cairo University

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