The Efficacy Of A Bioactive Resin Material Used As A Fissure Sealant As Compared To A Conventional Resin Regarding Its Retention, Marginal Integrity And Prevention Of Lesion Progression. A Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 主要终点
- Retention
研究概览
简要总结
The aim of this study is to investigate the retention, marginal integrity and potential to prevent lesion progression of a bioactive resin material compared to a conventional resin-based flowable composite during management of initial carious lesion in adult population over an 18 months period.
详细描述
Bio-active resin materials aim to possess the mechanical properties of resin materials in terms of higher wear resistance and dimensional stability over time. They also aim to mimic the biological activity of glass ionomers in terms of ion recharge and release. These new bio-active resin materials, with their lower particle size and better adaptability and polishability, might offer a substantial addition as fissure sealants if they fulfil the requisities satisfactory mechanical properties of resins and of ion recharge and release of glass ionomers.
The study will be conducted on demineralized fissures of permanent molars by application of a newly introduced giomer in one group while the other group will recieve a conventional resin material where they will be assessed for retention, marginal integrity and caries progression.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with good oral hygiene
- •Co-operative patients with initially demineralized fissures in permanent molars of the maxilla or mandible
排除标准
- •Medical Problems or Pregnancy
- •Lack of patient's approval and compliance
- •Presence of abnormal oral, medical, or mental condition
- •Known allergy of resin-based materials
- •Previous placements of sealants or restorations
- •Bruxism or mal-occlusion
研究组 & 干预措施
Bioactive resin (Giomer)
This group of patients will receive a bioactive resin "Beautifil flow plus X (Shofu Dental)" for treatment of their demineralized fissures
干预措施: Fissure sealing (Other)
Conventional resin
This group of patients will receive a conventional resin "Filtek Z350xt Flowable composite (3M ESPE)" for treatment of their demineralized fissures
干预措施: Fissure sealing (Other)
结局指标
主要结局
Retention
时间窗: 18 months
The sealing materials will be assessed for complete, partial or no retention. The assessment will be carried out by visual and tactile assessments and calculated as a percentage of the total sample.
次要结局
- Marginal integrity(18 months)
- Caries progression(18 months)
研究者
Amr Khaled Mostafa
Researcher
Cairo University