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临床试验/CTRI/2024/10/075708
CTRI/2024/10/075708尚未招募不适用

COMPARATIVE EVALUATION OF THE EFFICACY OF BRIX3000, SMART BURS, AND CONVENTIONAL METHOD IN CARIES EXCAVATION.

Akanksha shah1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年11月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
试验地点
1
主要终点
Colony forming unit will be checked to determine the efficacy of caries removal of these products

研究概览

简要总结

In this era of “Minimal Invasive Dentistry” preserving tooth structure, is increasingly becoming a standard in dental practice.  Conventional caries removal and cavity preparation entails the use of high-speed handpiece and burs which undoubtedly improved the speed and efficiency of cavity preparation but has many inevitable disadvantages. To overcome these, various newer caries excavation techniques have been suggested like air abrasion, air polishing, ultrasonic, Sono abrasion, lasers and the chemomechanical caries removal technique.

Chemomechanical caries removal (CMCR) is a non-invasive technique of removal of caries via eliminating infected dentin. BRIX-3000, papain-based chemical mechanical agent, with a proteolytic enzyme obtained from leaves latex and fruits of green papaya (Carica Papaya) that acts as a chemical debriding agent.

Another minimally invasive method of caries removal is by using polymer burs. The cutting edges will wear down in contact with harder materials, such as healthy dentin.

The recruited patients will be distributed equally into three groups

ü  Group I – Conventional method (n=22)

ü  Group II – BRIX3000 (n=22)

ü  Group III - Smart Burs (n=22)

Caries excavation will be done with respective agents, and the working time will be calculated. Microbial analysis will be carried out, thus all the samples will be evaluated for a total reduction in the bacterial count (CFU) and mean working time

study hypothesis is that minimal invasive technique can prove that they can effectively remove all the caries as well preserve tooth structure

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Wide Class 1 deep carious lesion on permanent molars 2.No pulpal involvement as evident on a radiograph 3.Good oral hygiene 4.Patient willing for voluntary participation and have signed the informed consent.

排除标准

  • 1.Pulpal exposure or bleeding during the excavation procedure 2.Patients with underlying systemic diseases.
  • 3.Teeth with any developmental anomalies 4.Teeth with any previous restorations.

结局指标

主要结局

Colony forming unit will be checked to determine the efficacy of caries removal of these products

时间窗: 1 week

次要结局

  • Shapiro Wilk test will be used to check which all variables will follow normal distribution(colony forming units will be calculated to determine the most efficient method)

研究者

发起方
Akanksha shah
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Akanksha shah

H.K.E. SOCIETY’S S. NIJALINGAPPA INSTITUTE OF DENTAL SCIENCES AND RESEARCH, KALABURAGI- 585105.

研究点 (1)

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