跳至主要内容
临床试验/NCT03740308
NCT03740308已完成不适用

Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth

Damascus University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年5月17日最近更新:
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
60
试验地点
1
主要终点
Changes of crowns integrity

研究概览

简要总结

This randomized clinical trial aims to compare the clinical outcomes of two full-coronal-coverage restorations (locally-made preformed Zirconia crowns [LMP] and NuSmile Zirconia crowns [Nu/ZR]) in treating carious primary teeth. Amongst the children attending the clinics of the Dental School at Damascus University, the ones having an indication for crowns restorations will be screened and if they are conformant to the inclusion criteria then they will be recruited until 60 teeth are reached (30 teeth for LMP/ZR restorations and 30 for Nu/ZR restorations).

详细描述

This randomized clinical trial compares the clinical outcomes of using two full-coronal zirconia restorations (locally-made preformed zirconia crowns, and NuSmile zirconia crowns) in treating carious primary teeth. Children attending to the clinics of the Faculty of Dentistry - Damascus University and who happen to be in need for dental restorations will be screened for the study's inclusion criteria till 60 teeth are recruited (30 teeth for locally made preformed zirconia crowns restorations and 30 for NuSmile zirconia crowns restorations). One crown only will be used for each patient (totally 60 patients) to ensure equalizing the variables for both groups. The randomization will be done using SPSS software version 20.0 (Armonk, NY; IBM Corp., USA). The study is going to be a double-blinded study (Patients blinding and Outcomes-assessor blinding). Simple descriptive statistics will be used for the analysis, also using Wilcoxon Signed-Rank test. The level of significance will be set at (α = 0.05) and the level of confidence at (95%). The intervention is preparing primary molars which have one or more indications for crowning, and according to manufacturer instructions. Then following up the treated primary molars for 1 month, 3 months, and 6 months intervals. The main goals are measuring and comparing the status of the gingiva and any improvements in the gingival health relative to the intervention, the plaque retention in regard to the gingival response to the material of restoration, and also the crowns resistance to changes, despite its high cost.

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, Outcomes Assessor)

盲法说明

Double-blinded study (Patients blinding & Outcome-assessor blinding).

入排标准

年龄范围
5 Years 至 5 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Patients within the age group of 4 to 8 years of age.
  • •Patients with good oral hygiene.
  • •Healthy children, i.e. free of any systematic diseases or any developmental disturbances of the teeth and jaws
  • •A minimal of two surfaces of caries in the targeted tooth
  • •Corresponding treated teeth has not got any crown earlier
  • •Patients with ECC as defined by the American Academy for Pediatric Dentistry.
  • •Cooperative patients who have a dental behavioral assessment of "definitely positive" according to Frankl behavior classification scale.

排除标准

  • •No patient is excluded by gender, race, or due to socio-economic backgrounds.

研究组 & 干预措施

Locally Made Zirconia Crowns

Active Comparator

One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions.

干预措施: Locally Made Zirconia Crowns (Device)

ZR Zirconia Crwons NuSmile ® Crowns

Experimental

One operator completes all the teeth preparing and restoring procedures. Local anesthesia is achieved using Lidocaine Hydrochloride 2% with Epinephrine 1:100,000. The teeth are then isolated using a rubber dam. After caries excavation, the teeth are prepared according to manufacturer instructions. (Same as Arm 1 Description)

干预措施: ZR Zirconia Crwons NuSmile ® Crowns (Device)

结局指标

主要结局

Changes of crowns integrity

时间窗: Evaluating after 1 month, 3 months, 6 months

Crowns integrity changes will be measured with the naked eye and the light cure device. The scores are as follows: (0 = No crack, No fracture, No chip) (1 = Chip) (2 = Crack) (3 = Fracture). (Cvar and Rygp 2005)

次要结局

  • Changes of gingival index(Evaluating after 1 month, 3 months, 6 months)
  • Changes of crown marginal adaptation(Evaluating after 1 month, 3 months, 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验