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临床试验/NCT03254069
NCT03254069已完成不适用

Changes in Occlusal Bite Force Following Placement of Stainless Steel Crowns on Primary Molars in Children

Jordan University of Science and Technology2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2011年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Maximum Occlusal Bite Force (MOBF)

研究概览

简要总结

The aim of this study was to determine if restoring primary molars with SSCs would improve children's OBF.

详细描述

Occlusal bite force (OBF) is an indicator of the functional status of the masticatory system. The level of maximum occlusal bite force (MOBF) results from the combined action of the jaw elevator muscles modified by jaw biomechanics and reflex mechanisms. The measurement of OBF has been widely used in dentistry to provide useful data for the evaluation of jaw muscle function and activity as well as effectiveness of prosthetic therapy.

Many indicators have been believed to assess the functional status of the masticatory system, such as body size, bite force, number of functional tooth units, and the occlusal contact area. Dental status formed with dental fillings, dentures, position and the number of teeth is an important factor in the value of the OBF.

Many studies were conducted to evaluate the effect of dental caries on OBF. Tsai et al. found a negative correlation between MOBF and the number of decayed teeth. Su et al. reported that the overall tooth decay was not related to the strength of OBF. They suggested that the severity of tooth decay may be more important than the number of teeth exhibiting decay.

Stainless Steel Crowns (SSCs) are considered the treatment of choice for severely decayed but restorable primary molars. A recent systematic review by Seale and Randall confirmed their previous work and reviews and appeared to continue to be supportive and in favor of SSCs.

SSCs has been blamed for premature contact related discomfort in the first few weeks after placement of SSCs. Zee and Amerongen reported that premature contacting SSC restored teeth will equilibrate over time and return to pretreatment levels in 15 to 30 days.

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
None

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Caucasian
  • Healthy child
  • In the primary dentition stage
  • Class I occlusion
  • No facial asymmetry
  • No cross bite
  • Have caries in the eight primary molars indicating placement of SSCs, with no reported pain on biting and no previous restorations
  • No gingival inflammation
  • No para functional habits

排除标准

  • did not meet the inclusion criteria stated above

研究组 & 干预措施

Stainless Steel Crown Arm

Experimental

Children with SSCs placed and followed longitudinal. Consent was obtained from all parents and verbal assent was obtained. The following data was collected: Demographic Data of the Children, clinical examination, radiographs, treatment planning, details of stainless steel crowns placement, OBF measurements were made before the SSC placement and periodically post placement

干预措施: Stainless Steel Crowns (Device)

Control Arm

No Intervention

A second group consisted of twenty-two children (11 females and 11 males; a mean age of 5.20 ± 0.36 years) were selected to act as a control sample and received no dental treatment. MOBF was recorded in these subjects at T0 and T5 (6 months after).

结局指标

主要结局

Maximum Occlusal Bite Force (MOBF)

时间窗: Six Months post placement

Occlusal Bite Force will be measured in Newton

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arwa Issa Owais

Principal Investigator

Jordan University of Science and Technology

研究点 (2)

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