Clinical and Radiological Evaluation of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
研究概览
简要总结
The purpose of this study is to evaluate and compare the clinical performance of Stainless Stain Crowns Placed Using the Hall Technique and Traditional Technique
详细描述
Stainless Stain Crowns (SSCs) will be placed on two primary molar teeth with proximal caries, in a split mouth design. 200 patients will be included in the study. The teeth will be randomized into two groups according to the technique.
Group 1: SSCs that will be placed using Traditional Technique Group 2: SSCs that will be placed using Hall Technique The cooperation of the child during the procedure will be assessed with Frankl scale. The crowns will be evaluated at baseline and 1., 6., 12., 18., 24. months. Radiographical evaluations will be at 6.,12. and 24. months. The data will be analysed statistically using chi square test and Log-Rank test and the Kaplan-Meier survival method will be used to estimate survival percentages.
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 (Participant)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients and parents of the patients who accept to participate and sign the informed consent
- •Patients who have two first and/or second primary molars with caries affecting at least two surfaces
- •Patients who are cooperative for the dental procedure
排除标准
- •Patients and parents of the patients who does not accept to participate and sign the informed consent
- •Teeth that are previously restored
- •Patients with a systemic disease,
- •Patients who have orthodontic treatment
- •Teeth which have a short period of time for succedaneous teeth to erupt
- •Teeth which need vital or non-vital endodontic treatment
- •Patients and/or parents who does not accept the esthetic appearance of SSC
结局指标
主要结局
Clinical performance of Stainless Stain Crowns (SSCs) Placed Using the Hall Technique and Traditional Technique
时间窗: 2 years
Assessment of SSCs placed with two different techniques on primary molar teeth. The cooperation of children will be assessed with Frankl Scale (1:definitely negative, 2:negative, 3:positive, 4:definitely positive). Evaluation criteria will be; * spontaneous pain (absent/present); * tenderness to percussion/palpation (absent/present); * mobility (no mobility/ 1mm/ 2mm/ 3mm mobility) * swelling (absent/present); * fistula (absent/present) * periapical/interradicular radiolucency (absent/present); * widened periodontal ligament (absent/present); * loss of lamina dura (absent/present); * internal/external root resorption (absent/present) * the marginal adaptation of each crown: good when the margins were sealed / poor when the margins were open * retention of the crown (absent/ present) * fracture of the crown (absent/ present) * gingival health/gingivitis (absent/ present) * plaque around the crown (absent/ present)
次要结局
未报告次要终点
研究者
Zafer Cavit Cehreli, DDS, PhD
Principal Investigator
Hacettepe University