Clinical and Radiographic Evaluation of Deep Occlusal Carious Molars Treated With Partial Caries Removal With and Without Using Silver Diamine Fluoride (SDF) Prior to Resin Composite Restoration. (A Randomized Clinical Trial)
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- clinical survival
研究概览
简要总结
The aim of the study is to evaluate the effect of SDF in maintaining pulp health after partial caries removal in permanent teeth with deep occlusal carious lesion clinically and radiographically
详细描述
Pre-operative clinical assessment:
Before starting the study, the participants will undergo radiographic examination to ensure that the carious lesion penetrate at least the inner one-half of the dentin thickness and show normal lamina dura and periodontal ligament.
Cavity preparation procedure:
Under local anesthesia and rubber dam isolation. A high-speed handpiece (T3 mini, Sirona GmbH, Bensheim, Germany) under air/water coolant and No. #245 bur will use to obtain the cavity outline allowing access to the carious lesion beyond the dentin-enamel junction. (Bitello-Firmino et al., 2018). Then, complete caries excavation will be performed in the cavity except at the floor where partial caries removal will be performed using sharp sterile excavator. Then cavities will be randomly divided into two groups according to the selected sealed envelopes.
Restorative treatment:
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)
盲法说明
The operator cannot be blinded because of the difference in operative and application procedures between control and intervention groups. The operator will blind until randomization into groups to avoid bias regarding the application of SDF to which tooth. However, the patients and assessors who carried out the radiographic assessment will be blinded of the treatment group. Finally, the treatment results will assess blindly by a statistician
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Class I carious lesions.
- •Lower and upper molars.
- •18 -50 years.
- •Not received antibiotic therapy since 1 month before sampling.
- •Males or Females (Both genders).
- •Co-operative patients approving the trial
排除标准
- •• known allergic reaction to fluoride or silver
- •Systemic disease or severe medical complications.
- •Periodontal problem.
- •Mobile teeth, arrest caries and non-vital teeth
- •Ulcerative gingivitis, and Stomatitis.
研究组 & 干预措施
resin modified glassionomer cement
Application of Resin modified glass ionomer cement (RMGIC) (Fuji Lining LC; GC, Tokyo, Japan) prior resin composite restoration (Filtek Z350 XT,3MESPE)
干预措施: resin modified glassionomer cement (Other)
silver diamine flouride
Application of 38% SDF (Riva Star, SDI, Bayswater, Australia), and Resin modified glass ionomer cement (RMGIC) (Fuji Lining LC; GC, Tokyo, Japan) prior resin composite restoration (Filtek Z350 XT,3MESPE).
干预措施: Silver diamine fluoride (Drug)
结局指标
主要结局
clinical survival
时间窗: 12 months
express as a binary variable indicating whether the restored tooth maintained its pulp vitality
次要结局
未报告次要终点
研究者
Laila Akmal Emad Eldien Elokaly
assistant lecturer
Cairo University