Assistant Lecturer of Pediatric Dentistry, Mansoura University (2019)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- post operative pain
研究概览
简要总结
This study conducted on thirty children aged 3-6 years old of both genders, have bilateral carious lower first primary molars. Pre-operative periapical x- ray were taken for both sides. The children were divided into 2 groups(SMART group and ART group). For Atraumatic Restorative Technique (ART technique), glass ionomer cement(GIC) was applied according to manufacturer's instructions. For Silver Modified Atraumatic Restorative Technique (SMART technique), SDF was applied carefully using bended micro sponge brush. It was applied directly to only the affected tooth surface. After one week GIC was applied according to manufacturer's instructions. Clinical and radiographic evaluation were done for all teeth at 6, 12 months. The data were collected then statistically analyzed using chi-square test to show the difference between groups.
详细描述
Sample size calculation:
For this study, a sample size of 30 was obtained using unpaired two sample two tail z-test. The effect size (dz=2.813) and the required sample size were calculated for α =0.05 and a confidence power of 0.8039, assuming a normal distribution.
Patient selection: This study conducted on thirty children aged 3-6 years old of both genders. The children selected from Pediatric Dental Clinic, Faculty of Dentistry, Mansoura University. Included children in the study were. Apparent healthy and free from any systemic diseases or chronic conditions. Child should have bilateral restorable carious lower first primary molars, occlusal caries, International Caries Detection and Assessment System(ICDAS) score (4, 5), asymptomatic or have reversible pulpitis. Radiographic examination show intact lamina dura, absence of internal and external pathological root resorption or periapical infection.
Randomization. The study was spilt mouth design. The right side of all participants was done atraumatic restorative technique (ART) and the left side was silver modified atraumatic restorative technique (SMART technique).
Clinical procedures:
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, Care Provider)
入排标准
- 接受健康志愿者
- 是
入选标准
- •This study conducted on thirty children aged 3-6 years old of both genders.
- •children in the study were. Apparent healthy and free from any systemic diseases or chronic conditions.
- •Child should have bilateral restorable carious lower first primary molars, occlusal caries, ICDAS score (4, 5), asymptomatic or have reversible pulpitis.
- •Radiographic examination show intact lamina dura, absence of internal and external pathological root resorption or periapical infection.
排除标准
- 未提供
研究组 & 干预措施
ART group
Atraumatic restorative technique: excavation of caries then application of Glass ionomer capsule (GC, USA)
干预措施: Atraumatic Restorative Technique (ART) (Procedure)
SMART group
SMART technique: excavation of caries and application of silver diamine fluoride (SDF 38%) then glass ionomer cement
干预措施: SMART Technique (Procedure)
结局指标
主要结局
post operative pain
时间窗: 12 months
numerical/visual analogue scale 0 no pain 10 worst possible pain
radiolucency
时间窗: 12 months
x ray will be done( qualitative assessment looking for presence of interradicular or periapical radiolucency will be performed and will be scored as yes or no)
Pathological internal or external root resorption
时间窗: 12 months
x ray will be done( qualitative assessment looking for presence of pathological internal or external root resorption will be performed and will be scored as yes or no)
次要结局
- tooth mobility(12 months)
- Presence or absence of fistula(12 months)