Performance of Flowable Giomer Versus Nanofilled Flowable Composite With or Without Giomer Coat In Conservative Occlusal Cavities: 18 Months Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Fracture and Retention of Material
研究概览
简要总结
With limited evidence-based information in literature the goal of this clinical trial is to learn about Flowable Giomer and compare it to Nanofilled Flowable Composite in Conservative Occlusal Cavities. It is beneficial to evaluate the newly introduced material using a randomized controlled clinical trial to test the null hypothesis that this new flowable giomer (Shofu™ Beautifil Injectable X, Shofu Dental Corp., Japan) and conventional resin-based nano-filled composite (Filtek™ Z350 XT 3M ESPE, USA) which will then be coated with (Shofu™ PRG Barrier Coat, Shofu Dental Corp., Japan) will have the same clinical performance as flowable resin composite as a preventative restorative restoration in permanent molars.
详细描述
This study will be conducted to clinically evaluate caries prevention and marginal integrity of flowable giomer and flowable resin composite coated with S-PRG in comparison to flowable resin composite as a preventative resin restoration in patients requiring minimally invasive simple class I cavities in permanent molars over 18 months test period.
Teeth that meet the inclusion criteria will be selected. The occlusal surfaces will be cleaned by pumice and a low speed polishing brush. Baseline recording of carious lesions will be carried out using DIAGNOdent pen. Cavity preparation will be carried out using number 330 (Mani, Inc., Japan) bur.
All the tested materials Shofu™ Beautifil Injectable X, (Shofu Dental Corp., Japan flowable composite) and Filtek™ Z350 XT (3M ESPE, USA) Flowable composite: Conventional resin-based nano-filled flowable composite which will then be coated with Shofu™ PRG Barrier Coat, (Shofu Dental Corp., Japan) will be used according to manufacturer instructions and comparator restorative material Filtek™ Z350 XT (3M ESPE, USA) Flowable composite.
All restorations will be finished using flame-shaped finishing stone (Mani, Inc., Japan) and polished using rubber cups (Kerr Corporation, Orange, CA, USA).
The primary and secondary outcomes will be measured at four intervals 1 week after placement, 6 months follow up, 12 months follow up and 18 months follow up.
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
- 19 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral or Bilateral small Class I carious lesions
- •Patients with good oral health
- •Small Class I carious lesion in occlusal pits and fissures
排除标准
- •Existing systemic diseases
- •Severe medical complications
- •Allergy history concerning methacrylates
- •Pregnancy
- •Heavy smoking
- •Evidence of severe bruxism, clenching or temporomandibular joint disorders
- •Presence of existing occlusal restoration
- •Periapical or pulpal pathology
- •Tooth hypersensitivity
- •Possible prosthodontic restoration of teeth
- •Endodontically treated teeth
- •Severe periodontal affection
研究组 & 干预措施
Flowable Giomer
Patients with conservative carious class I occlusal cavities will be treated with Shofu™ Beautifil Injectable X, Shofu Dental Corp., Japan flowable composite Novel bio-active flowable resin containing nano S-PRG (Surface Pre-Reacted Glass ionomer).
干预措施: Flowable Giomer (Other)
Nano-filled Flowable Composite with S-PRG barrier coat
Patients with conservative carious class I occlusal cavities will be treated with Filtek™ Z350 XT 3M ESPE, USA Flowable composite: Conventional resin-based nano-filled flowable composite which will then be coated with Shofu™ PRG Barrier Coat, Shofu Dental Corp., Japan.
干预措施: Flowable Nano-filled composite with S-PRG barrier coat (Other)
Nano-Filled Flowable Composite
Patients with conservative carious class I occlusal cavities will be treated with Filtek™ Z350 XT 3M ESPE, USA Flowable composite: Conventional resin-based nano-filled flowable composite.
干预措施: Flowable Nano-filled composite (Other)
结局指标
主要结局
Fracture and Retention of Material
时间窗: T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up
World Dental Federation (FDI) criteria (Hickel et al.,2010) Scores: 1. Clinically excellent/ very good 1.1 No fractures/cracks 2. Clinically good 2.1 Small hairline crack 3. Clinically sufficient/ satisfactory 3.1 Two or more larger hairline cracks and/or material chip not affecting the marginal integrity or approximal contact 4. Clinically unsatisfactory (but repairable) 4.1 Material chip fractures which damage marginal quality or approximal contacts 4.2 Bulk fractures with partial loss (less than half of the restoration) 5. Clinically poor (replacement necessary) 5.1 Partial or complete loss of restoration or multiple fractures
次要结局
- Occlusion and wear(T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up)
- Dental hard tissue defects at restoration margins(T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up)
- Postoperative hypersensitivity/pulp status(T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up)
- Form and contour(T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up)
- Marginal Adaptation(T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up)
- Incidence of new carious lesions(T0= 1 week postoperative T1= 6 months follow up T2= 12 months follow up T3= 18 months follow up)
研究者
Amina Ahmed Abdellatif Hassan Gaafar
Principle Investigator
Cairo University