Clinical Performance and Wear Resistance of Milled Resin Composite Material Versus Direct Nanohybrid Bulk-Fill Resin Composite in Restoration of Endodontically Treated Posterior Teeth Over One Year: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Degree of Continuity between natural tooth structure and the restoration
研究概览
简要总结
In patients with endodontically treated teeth, will the Indirect Milled composite Endo-crown restorations have a better clinical performance and more wear resistance than the Direct Bulk-Fill resin composite restorations over one year?
Primary Objective: To evaluate clinical performance of different Techniques of Composite Restorations (Indirect restorations using a CAD/CAM grinding process, BRILLIANT Crios, Coltène/Whaledent AG, Switzerland or Direct a light-cured, bulk-fill nanocomposite restorative material, Filtek™ One Bulk Fill Restorative, 3M ESPE Dental Products, USA) in Endodontically treated posterior teeth.
详细描述
The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University; The operator in charge will be Esraa Esmeail Hussien.
Null-hypothesis: There are no differences in the clinical performance of indirect CAD/CAM milled composite when compared to direct bulk-fil composite endocrowns when in the posterior area.
Aim: This clinical trial will be conducted to assess the clinical performance of using indirect Milled composite or direct bulk-fill resin composite Endo-crowns for restoring the endo-treated teeth, as well to measure the amount of wear on the occlusal tables of both restorations using Digital Scanner.
Patients will be selected from the outpatient clinic of the department Conservative Dentistry Department, Faculty of Dentistry, Cairo University
Clinical Steps:
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
- 16 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •of participants:
- •Patients with asymptomatic endodontically treated molars.
- •Males or Females.
- •Good oral hygiene.
- •Co-operative patients approving to participate in the study.
- •Inclusion Criteria of teeth:
- •Asymptomatic endodontically treated upper or lower molars with
- •Homogenous root canal filling ending 1-2mm from the radiographic apex.
- •Proximal compound cavities.
- •Favorable occlusion.
排除标准
- •of participants:
- •High caries index with poor oral hygiene.
- •Severe medical complications.
- •Pregnancy.
- •Allergic history concerning methacrylates Disabilities.
- •Heavy smoking.
- •Xerostomia.
- •Lack of compliance.
- •Evidence of parafunctional habits.
- •Temporomandibular joint disorders.
- •Exclusion criteria of the teeth:
- •Teeth with remaining wall thickness less than 1mm.
- •Teeth with improper or symptomatic endodontic treatment.
- •Deep subgingival cavity margins.
- •Possible future prosthodontic restoration of teeth.
- •Severe periodontal problems.
研究组 & 干预措施
Indirect Restoration
Milled Resin Composite Block, Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments (inorganic pigments such as ferrous oxide or titanium dioxide).
干预措施: Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process. (Other)
Direct Restoration
3M™ Filtek™ One Bulk Fill Restorative is a visible light activated, restorative composite optimized to create fast and easy restorations.
It is composed of fillers which are a combination of a non-agglomerated/non-aggregated 20 nm silica filler, 4 to 11 nm zirconia filler, zirconia/silica cluster filler and ytterbium trifluoride filler consisting of 100nm particles. The inorganic filler loading is about 76.5% by weight (58.5% by volume).
干预措施: Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process. (Other)
结局指标
主要结局
Degree of Continuity between natural tooth structure and the restoration
时间窗: 12 months
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Degree of Continuity between natural tooth structure and the restoration
时间窗: Immediately after procedure
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
Degree of Continuity between natural tooth structure and the restoration
时间窗: 6 months
Tactile sensation checking the anatomic form to show if there is no discontinuity, Slight discontinuity, or discontinuity and failure
次要结局
- Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins(12 months)
- Pain due to dentin hypersensitivity (evaporative stimulus)(12 months)
- The degree of mismatch from the normal range of tooth shades and translucency(12 months)
- Distance penetrated by the Explorer at the tooth restoration interface(12 months)
- Area of continuous movement of an explorer across the surface of the restoration(12 months)
- Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins(Immediately after procedure)
- Distance penetrated due to secondary caries by visual evidence of dark keep discoloration adjacent to the restoration but not directly associated with cavosurface margins(6 months)
- The degree of mismatch from the normal range of tooth shades and translucency(Immediately after procedure)
- The degree of mismatch from the normal range of tooth shades and translucency(6 months)
- Pain due to dentin hypersensitivity (evaporative stimulus)(Immediately after procedure)
- Pain due to dentin hypersensitivity (evaporative stimulus)(6 months)
- Area of continuous movement of an explorer across the surface of the restoration(Immediately after procedure)
- Area of continuous movement of an explorer across the surface of the restoration(6 months)
- Distance penetrated by the Explorer at the tooth restoration interface(Immediately after procedure)
- Distance penetrated by the Explorer at the tooth restoration interface(6 months)
研究者
Esraa Esmeail Hussien
Principal investigator
Cairo University