Pain Assessment During Chemo-Mechanical and Smart Burs Caries Removal Versus Atraumatic Restorative Treatment in Carious Primary Molars: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 33
- 主要终点
- Pain assessment
研究概览
简要总结
The aim of the clinical trial is to assess pain during Atraumatic Restorative Treatment (ART), Smart Burs and Chemo-mechanical Caries Removal (CMCR) in primary molars.
详细描述
The principles of the caries removal have changed greatly in the last decade. The use of local anesthesia with conventional techniques"high-speed hand piece" increase the fear and anxiety of the child. Minimally invasive techniques reduce the pain and anxiety of the child by eliminating the use of local anesthesia.
In ART, soft carious tissue is removed by hand instruments. Although this technique is very simple.
Moreover, Smart Burs are more efficient in removal of soft infected dentine than ART leaving the affected dentin intact; as when they touch hard dentin, they become dull.
Finally, the recent effective method of caries removal is CMCR. The chemical agent contains proteolytic enzyme which destructs partially degraded collagen, leaving the infected dentin soft and easy to be excavated.
Therefore, the aim of this study is to assess pain during Atraumatic Restorative treatment, Smart Burs and Chemo-Mechanical Caries Removal in primary molars.
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
- 4 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caries in second primary molars within enamel/ dentin without pulp disease.
- •There is a clear band of dentin coronal.
- •Cooperative and healthy children.
排除标准
- •Presence of signs and symptoms of necrosis.
- •Root caries.
- •History of spontaneous pain.
研究组 & 干预措施
Atraumatic Restorative Treatment (ART)
Atraumatic Restorative Treatment is a simple technique based on preservation of sound tooth structure and minimal patient's discomfort.
干预措施: Atraumatic Restorative Treatment (ART) (Procedure)
Smart Burs
Smart Burs are minimally invasive technique which selectively removes the infected carious dentin leaving the affected intact dentin.
干预措施: Smart Burs (Procedure)
Chemo-Mechanical Caries Removal (CMCR)
A chemical agent which selectively removes the carious dentin by breaking the denatured collagen fibers making them soft and preserving the healthy dentin without drilling.
干预措施: Chemo-Mechanical Caries Removal (CMCR) (Procedure)
结局指标
主要结局
Pain assessment
时间窗: at baseline
The pain will be assessed by Visual Analogue Scale (VAS)
次要结局
- Efficacy of caries removal(at baseline)
- Time taken for caries removal(at baseline)
研究者
Reham Mahmoud Abdel Sattar El sayed
principle investigator
Cairo University