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临床试验/NCT06833177
NCT06833177尚未招募不适用

Eighteen Months Clinical Evaluation of Hybrid Ceramic Inlays Cemented with Giomer Based Self-adhesive Resin Cement Versus Resin-based Cement in Carious Posterior Teeth: Randomized Controlled Clinical Trial

Cairo University0 个研究点目标入组 50 人开始时间: 2025年8月20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
Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria

研究概览

简要总结

Minimally invasive bonded partial restorations have become a crucial component of contemporary dental treatments. They address the shortcomings of direct restorations and provide patients with a less damaging alternative to full coverage restorations, which can be more harmful to the dental structure. Indirect inlay composite restorations have become a popular choice in restorative dentistry due to their aesthetic appeal and durability. These restorations allow for the preservation of tooth structure while utilizing the mechanical advantages of modern adhesive technology, which can reinforce the weakened compromised tooth structure.

The use of different adhesive materials with Ceramage can significantly influence the success of the restoration. Adhesive materials play a crucial role in ensuring a strong bond between the indirect restoration and the tooth structure. Additionally, the choice of adhesive material can also affect the ease of the cementation process. Self-adhesive resin cement simplifies the procedure by eliminating the need for separate bonding agents, thus reducing the risk of technique sensitivity which can lead to more consistent clinical outcomes and improved patient satisfaction.

Overall, the combination of Ceramage with appropriate adhesive materials offers a reliable and aesthetically pleasing solution for indirect inlay composite restorations, enhancing both the biological, functional and esthetic outcomes of dental treatments.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Posterior vital tooth with a large carious lesion (ICDAS 4/5)
  • •Posterior vital tooth with a broken restoration that should be replaced (ICDAS 4-7/5-7).
  • •Vital, periodontally sound and with positive reaction to cold stimulus.
  • •Fully erupted posterior molar in normal functional occlusion with natural antagonist and adjacent teeth.

排除标准

  • •Teeth with clinical symptoms of pulpitis such as spontaneous pain or sensitivity to pressure.
  • •Non-vital teeth, Fractured or cracked teeth.
  • •Endodontically treated teeth.
  • •Periodontally affected teeth.

研究组 & 干预措施

Cementation via Beautilink SA cement

Experimental

Ceramage inlays will be cemented using Beautilink SA cement

  • To enhance the adhesion, adhesive bonding agent BeautiBond Xtreme, Shofu will be applied on the tooth and cured according to the manufacturer's instructions.
  • Press the plunger of the auto-mix syringe of Beautilink SA to dispence the cement on the adhesive surface of the restoration.
  • Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 5 minutes after light-curing to allow for chemical curing.

干预措施: Beautilink SA cement (Other)

Cementation via RelyX resin cement

Active Comparator

Ceramage inlays will be cemented using RelyX resin cement

  • To enhance the adhesion, adhesive bonding agent 3M™ Scotchbond™ Universal Plus Adhesive will be applied on the tooth and cured according to the manufacturer's instructions.
  • Application of 3M™RelyX™ Universal Resin Cement into the cavity
  • Using a light-curing unit to cure each surface and marginal areas for 10 seconds. For areas where the light cannot reach, or when using opaque cement, hold the restoration in place for approximately 6 minutes after light-curing to allow for chemical curing.

干预措施: RelyX resin cement (Other)

结局指标

主要结局

Clinical Performance assessing Biological, Mechanical and Esthetic Parameters Using Modified USPHS Criteria

时间窗: T0: 12 months T1: 18 months

Alpha being the best results and Charlie being the worst results

次要结局

未报告次要终点

研究者

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

Mariam Mohamed Ahmed Gomaa

MSc. 2024, Faculty of Dentistry, Cairo University

Cairo University

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