The Effectiveness of Carie Care, Chemomechanical Caries Removal Technique in Primary Teeth (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Child pain perception
研究概览
简要总结
Chemomechanical caries removal systems have emerged as a possible valuable alternative to conventional rotary caries removal techniques in pediatric patients. Carie-Care™ is an economically minimally invasive approach that selectively removes caries-infected tissue leaving the caries-affected tissue to conserve tooth structure
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open carious lesions with a moderately deep dentin carious lesion(scores five or six, according to the International Caries Detection and Assessment System[ICDAS].
- •The access of the carious lesion has to be large enough to allow the penetration of the excavator
- •Children with behavior rating 3 or 4 according to the Frankl scale
排除标准
- •Clinical or radiographic evidence of pulp, furcation, or periapical pathosis
- •Proximal caries evidenced by bitewing x-ray
结局指标
主要结局
Child pain perception
时间窗: Through procedure completion
The type of response obtained for each observation was given a numerical value (score) like Score 1 (comfort), Score 2 (mild discomfort), Score 3 (moderately painful), and Score 4 (painful)
Efficacy of caries removal
时间窗: Through procedure completion
Caries removal will be rated according to the scoring criteria that range between score zero where caries is removed completely to score 5 where caries is present at the base,walls and margins of the cavity
Child behavior
时间窗: Through procedure completion
Score 1: Definitely positive, Good rapport with the dentist, interested in the dental procedures, laughing and enjoying the situation. Score 2: Positive, Acceptance of treatment; at times cautious, willingness to comply with the dentist, at times with reservation but patient follows the dentist's directions cooperatively. Score 3:Negative, Reluctant to accept treatment; uncooperative, some evidence of negative attitude but not pronounced, i.e. /sullen, withdrawn. Score 4: Definitely negative, Refusal of treatment, crying forcefully, fearful or any other overt evidence of extreme negativism.
Time taken for caries removal
时间窗: Through procedure completion
The time taken for the procedures will be measured from the beginning of caries removal procedure till the cavity is confirmed to be free of caries with the help of a stop watch and will be recorded in seconds.
次要结局
未报告次要终点
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University