Atraumatic Restoration Treatment Compared to the Hall Technique for Management Hypomineralization Second Primary Molars
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Dental pain assessed by FLACC scale
研究概览
简要总结
Aims: Evaluation of treatment success on HSPM-affected molars after ART and Hall technique.
comparison of pain during treatment with ART and Hall technique in HSPM. comparison of child and parent satisfaction with restorations used by ART and Hall technique.
Design: A randomized, controlled, crossover clinical study including thirty children.
详细描述
Background and Aims:
Despite the widespread prevalence of HSPM:
there are no comparative studies yet between ART and Hall technique in the restoration of HSPM.
there are no studies yet on the success of ART in the treatment of HSPM.
Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absolute positive, positive or negative behavior according to the Frankel Scale.
- •Healthy, both physically and mentally.
- •Do not take medications that interfere with the assessment of pain within 24 hours prior to treatment.
- •A child with HSPM-affected primary second molars on the right and left side in one jaw.
- •The HSPM affected teeth from 2-6 degree in Ghanim scale.
- •Teeth with atypical carious lesions.
- •Teeth with post-eruption destroyed
- •The presence of a clear, intact dentinal bridge between the caries and pulp radially.
排除标准
- •Allergy to the substances used in restoration.
- •Presence of general or developmental medical conditions.
- •Teeth with pulpitis inflammation or apical lesion or non-restorable.
- •Teeth closed to being replaced.
研究组 & 干预措施
A (Hall Technique)
31 child will be treated by one performed metal crown using Hall technique on one of HSPM affected tooth.
The correct size of SSC for tooth will be selected. Use the separating rubber if necessary. Dried the tooth and cemented the SSC by glass ionomer luting cement and used finger pressure to seat the crown and instructed the child to bite down on the SSC.
Half of the total number of children will received performed metal crown at the first by divided them randomly to the two groups using the randomization table.
干预措施: Hall technique (Combination Product)
B (ART)
31 child will be treated by Bulk fill glass hybrid restorative system (Equia Forte HT®) using Atraumatic restoration treatment on one of HSPM affected tooth.
Isolate the tooth by cotton rolls, remove the carious soft tissue using hand instrument excavators then condition the cavity with a polyacrylic acid solution 11.5% for 10 seconds. After washed and dried the cavity insert the GIC and protect it by Equia forte coat.
Half of the total number of children will received ART at the first by divided them randomly to the two groups using the randomization table.
干预措施: ART (Combination Product)
结局指标
主要结局
Dental pain assessed by FLACC scale
时间窗: During the placement of the restoration
Evaluated by outcome assessor using the faces, legs, activity, cry, consolability behavioral rating scale (FLACC scale) a behavioral pain assessment scale which has five criteria face, legs, activity, cry, consolability, which are each assigned a score of 0,1 or2. Total score of scale is summed in range 0 to10, where:0=relaxed and comfortable; 1-3=mild discomfort; 4-6=moderate pain; 7-10=severe pain.
次要结局
- Child Satisfaction with the restoration assessed by the Likert scale(After one month from treatment)
- Parent Satisfaction with the restoration assessed by the Likert scale(After one month from treatment after asking the child)
- Child Satisfaction with the restoration assessed by the Likert scale(Immediately after the placement of the restoration)
- Parent Satisfaction with the restoration assessed by the Likert scale(Immediately after the placement of the restoration after asking the child)