Clinical Performance of a Flowable Giomer Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- The clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars
研究概览
简要总结
The aim of the present study is to assess Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo,
Japan) in class II cavities of primary molars regarding the following objectives:
The primary objective To evaluate and compare the clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars after 3,6, and 12 months. The secondary objective To assess the effect of different independent variables on the treatment outcome of the experimental restorative materials.
Research question:
Is there a difference in the clinical performance between flowable giomers and highly viscous glass ionomer in restoring class II cavities of primary molars?
Null Hypothesis There is no difference in the clinical performance between Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) after one year of follow up.
详细描述
Study design:
The study will be two parallel-arm, double blinded randomized, controlled clinical trial with an equal allocation ratio.
Study Setting:
The study will be conducted at Pediatric dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University.
Ethical Considerations:
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •inclusion criteria of study participants:
- •4 to 8 years old medically free children.
- •Cooperative children classified as class 3 or 4 based on Frankel et al. classification
- •Children who had at least one active dentinal carious lesion on proximal surface of primary molars
- •inclusion criteria of teeth:
- •Primary molars with active dentinal carious lesion on their proximal surface score 4, 5 using ICDAS.
- •Primary molars with proximal carious lesion extended to outer and middle third of dentin scored D1and D2 that will be detected by bitewing radiograph.
- •Simple or compound class II cavities be present
- •The antagonist and the adjacent tooth should be present
- •Primary molar should have at least 2/3 of the root present
排除标准
- •exclusion criteria of study participants
- •Refusal of the parents to sign the informed consent
- •Presence of deep bite or any pictures of malocclusion and any parafunctional habits.
- •exclusion criteria of teeth
- •Presence of any unprovoked pain, pulp exposure,clinical swelling, abscess or fistula.
- •Presence of any physiological or pathological mobility.
- •Very deep subgingival cavities
- •Teeth with congenitally missing successor
结局指标
主要结局
The clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars
时间窗: 12 months
The restorations will be evaluated using the FDI criteria having esthetic, functional, and biological properties
次要结局
- The effect of different independent variables on the treatment outcome of the experimental restorative materials.(12 months)
研究者
Sarah Emad Ali El-Din
Assistant lecturer at the Pediatric Dentistry and Dental Public Health Department-Faculty of Dentistry
Ain Shams University