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临床试验/NCT06187259
NCT06187259已完成不适用

Efficacy of Smart Burs II ® in Selective Caries Removal in Permanent Molars: Randomized Controlled Trial

Suez Canal University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Assessment of caries removal efficiency by visual examination

研究概览

简要总结

A more biological and conservative technique of caries removal has emerged with minimally invasive restorative dentistry's advent. As a result, Smart Burs II has become a self-limiting, sensitive tool for removing caries. The current study aimed to validate and contrast the polymer burs' efficacy (Smart Burs II) versus conventional burs (Carbide burs) for infected carious dentin's selective removal in permanent first molars. Thirty permanent first molars fulfilling the inclusion criteria were chosen in 8-11 years old children with class I occlusal carious lesions. Group 1 (n=15) and Group 2 (n=15) were randomly assigned to have carious dentin removed utilizing standard carbide bur and a smart Bur II, consecutively. By employing caries detector dye, the effectiveness of caries removal was quantified as 0, 1, 2, 3, 4, or 5. The volume of removed carious tissue was recorded using impression material which was inserted into a calibrated insulin syringe. A statistically significant difference was discovered in the volume of removed carious tissue between both groups, while the efficiency of caries removal using either bur has no significant difference. Smart Bur II was more conservative in the carious dentin's removal than carbide bur. Smart Bur II was as efficient as carbide bur in caries removal.

详细描述

One of the prime goals of the evolution of minimally invasive dentistry is conserving healthy tooth structure by eliminating infected carious dentin while retaining impacted carious dentin intact and minimizing the needless destruction of teeth. Dentin carious lesions is formed of two distinct layers that differ from one another regarding their microscopic structure and physiological and bacteriological characteristics. The external superficial infected layer is soft, heavily contaminated by bacterial invasion, and incapable of being repaired owing to the collagen fibers' irreversible denaturation. While the affected dentin, which is a hard substance with few bacteria and can be remineralized due to limited collagen degradation, is located beneath the infected layer.

Conventional caries removal could possibly be traumatic as it tends to remove both infected and affected dentin, which may induce an unneeded weakening of the tooth structure and often leads to overextended cavities. Moreover, it has deleterious thermal influences on the pulp. Accordingly, the dental industry has recently witnessed the emergence of the polymer bur, which manufacturers claim is the best for selectively removing caries while minimizing the patient's discomfort. By introducing a polymer prototype bur in 2003, a potential substitute for traditional techniques of removing carious dentin has emerged. This self-limiting polymer bur is known as SmartBurTM, a variant of SmartPrepTM (SS White, Lakewood, NJ, USA). It is a single-use bur-like instrument constructed of a polymer with a lower hardness than healthy dentin. Different sizes are available; #4, #6, and #8 for right angle latch handpieces.

Polymer bur tools resemble conventional burs in appearance, but they are made of unique polymer material rather than metal. The cutting edges are not spiral, like those of a shovel. The polymer material was designed to be softer than healthy dentin (Knoop hardness 70-90) but harder than carious, softening dentin (Knoop hardness 50-70) (Knoop hardness 0-30). Therefore, it has a knoop hardness of 50 kg/mm2, and its cutting elements effectively remove soft dentin but cannot remove healthy dentin.

Materials and methods Sample size calculation The minimum required sample size will be 15 molars in each group. Thus, a total of thirty permanent first molars will be divided into two groups for this study. The sample size was computed as per G*Power software version 3.1.9.3.

Allocation of samples A 1:1 allocation ratio was used to allocate each of the 30 selected permanent first molars to either Group 1 (Carbide Bur group) or Group 2 (Smart Bur II group).

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)

盲法说明

single

入排标准

年龄范围
8 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy children of both genders in the age group of 8-11 years and rated as definitely positive or positive using Frankl Behaviour Rating Scale
  • 30 permanent first molars with class I (occlusal) active carious lesion classified as code 5 , according to the international caries detection and assessment system, involving dentin with a cavity opening diameter of 2mm.
  • Permanent molars with absence of peri-apical or inter-radicular radiolucency.

排除标准

  • Molars with developmental anomalies.
  • Decayed molars that show clinical or radiographic evidence of pulpal involvement.
  • Parental refusal to sign the informed consent.

结局指标

主要结局

Assessment of caries removal efficiency by visual examination

时间窗: baseline (immediately after caries removal procedures) Up to 3 minutes, no follow up is required.

Visual examination to assess the color of dentin and evidence of the presence or absence of soft caries.

Assessment of caries removal efficacy by using caries detector dye

时间窗: baseline (immediately after caries removal procedures) Up to 10 minutes, no follow up is required.

Caries removal efficacy was assessed using the Ericson rating scale "The Ericson rating scale was used to assess the residual caries. Caries removal status scores are defined as 0, 1,2,3,4, or 5, with 5 indicating the highest residual caries.

Assessment of caries removal efficiency by tactile examination

时间窗: baseline (immediately after caries removal procedures) Up to 5 minutes, no follow up is required

Tactile sensation to assess the texture, hardness, and consistency of dentin, i.e. the explorer should not stick to the dentin when moved along the surface without a catch or a tug-back sensation.

Assessment of the volume of the removed carious tissue in cubic millimeters (mm3)

时间窗: baseline (immediately after caries removal procedures) Up to 15 minutes, no follow up is required.

Using impression material and a calibrated insulin syringe for both groups, the amount of removed carious tissue was measured by computing the difference between the cavity's initial volume before caries removal and the final volume of the cavity after caries removal

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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