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临床试验/NCT07457749
NCT07457749招募中1 期

Clinical Performance of a Novel Self-cured Resin Composite Compared to a Light-cured Bioactive Resin Composite Restoration in Proximal Cavities of Posterior Teeth: A 2-year Randomized Controlled Clinical Trial

British University In Egypt1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月18日最近更新:
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
50
试验地点
1
主要终点
Proximal contact tightness of examined class II restorations

研究概览

简要总结

The development of dental caries is multi-factorial mainly due to the presence of 4 elements which are: dental biofilm, fermentable carbohydrates , dental hard tissue and time. Other additional social and environmental factors can have a substantial impact on the onset and course of the disease. Dietary habits, oral hygiene, salivary flow and fluoride exposure are key factors that influence the susceptibility to dental caries. If dental caries is properly managed, it is a preventable and reversible disease. The proximal teeth surfaces are the most susceptible sites for demineralization from the acidic byproducts. In modern restorative dentistry, clinicians always seek solutions that streamline procedures, improve outcomes and reduce chair time for patients. Traditional light-cured composite systems often involve a complex seven step process which includes etching, priming, bonding and curing which consumes from 90 to 120 seconds to be completed. With each additional step, the risk of technique errors increases, potentially compromising the longevity of the restoration. Self-cure composites, with their simplified application process, are emerging as a preferred choice over the traditional seven-step composite materials. Recently, a novel self-cured high-performance bulk-fill restorative material has been introduced into the market (Stela, SDI, Victoria, Australia). It's particularly known for its "unlimited" depth of cure and self-adhesive properties.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 47 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects between the ages of 18-47 years old
  • Primary caries removal
  • Good or moderate oral hygiene
  • Free of periodontal diseases (probing depth and attachment levels within normal limits/ no furcation involvement/ no mobility)
  • Cooperative patients who agree to keep the scheduled recall appointments for data collection and maintenance

排除标准

  • Composite or amalgam removal
  • Caries extended to the cemento-enamel junction in Class II caries
  • Grade II or III mobility
  • Considerable periodontal disease without treatment
  • Endodontically treated teeth with extensive loss of tooth tissues
  • Severe wear facets and/or parafunctional activities as clenching or nocturnal bruxism.
  • Subjects who are pregnant during the duration of the study
  • Subjects with high caries activity

研究组 & 干预措施

Beautifil II , Shofu (Light-cured Resin Composite)

Active Comparator

It is a light-cured bioactive nanohybrid resin composite restorative material

干预措施: Beautifil II, Shofu, Japan (Drug)

Stela, SDI, Australia (Self-cured Resin Composite)

Experimental

It is a novel self-cured bulk-fill restorative material. It is offered in two application forms (Stela Automix & Stela Capsule) that is used in combination with a proprietary adhesive primer (Stela Primer), which does not require light curing, but it undergoes polymerization upon contact with the restorative material in addition to its ability to generate minimal shrinkage stresses. The polymerization starting at the bottom of the cavity helps drastically reduce polymerization shrinkage stress, which is a common cause of post-operative sensitivity.

干预措施: Stela, SDI, Australia (Drug)

结局指标

主要结局

Proximal contact tightness of examined class II restorations

时间窗: Baseline (after 1 week) and at 6, 12, 18, 24 months

This primary outcome will be measured using the FDI criteria for direct and indirect restorations

次要结局

  • Postoperative Hypersensitivity(Immediate post procedure and after 1 week)

研究者

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

SARA SAWAF

Demonstrator at the Conservative Department, Faculty of Dentistry, The British University in Egypt

British University In Egypt

研究点 (1)

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