背景:除了常规治疗,可以使用化学-机械龋齿去除剂。在牙科中一直在增加的治疗方式是抗微生物光动力疗法(aPDT)。Bixaorellana正在研究在aPDT中的应用。该方案旨在确定具有Bixaorellana提取物的aPDT在深龋病变中的有效性。
方法:将选择总共160颗具有深咬合性龋齿的牙齿,并将其分为4组:G1-对照组(低速钻头去除龋齿);G2-Papacarie™部分去除龋齿(FórmulaeAção,圣保罗,SP,巴西);G3-Papacarie™和应用程序Bixaorellana提取物(20%)(FórmulaeAção,圣保罗,SP,巴西);G4-使用Papacarie™去除部分龋齿,并使用带LED的Bixaorellana提取物(20%)(ValoCordlessUltradent®,南约旦,UT,美国)(aPDT)。治疗后,所有牙齿都将用玻璃离聚物水泥修复,并进行临床和影像学随访,立即进行评估,1周,以及1、3、6和12个月。治疗前后的牙本质样品将进行微生物学分析。治疗的有效性将用微生物(菌落形成单位,龋齿组织去除之前和之后),射线照相(根尖周区域的完整性和射线可透区域的最终变化),和临床检查(修复材料在腔中的保留和继发性龋齿的发生),以及手术所需的时间和手术期间麻醉的需要。如果数据分布是正常的,方差分析(ANOVA)将用于因变量和自变量。如果数据分布不正常,弗里德曼检验将用于因变量。对于自变量,将使用Kruskal-Wallis测试。
结论:已经开发了使用aPDT治疗龋齿的方法,但文献中很少有对照临床试验证实其疗效。
背景:该协议在ClinicalTrials.gov注册,编号为NCT05236205,首次发布于2022年1月21日,最后更新于2022年5月10日。
BACKGROUND: Alternatively to conventional treatments, chemo-mechanical caries removal agents can be used. A modality of treatment that has been increasing in dentistry is antimicrobial photodynamic therapy (aPDT). Bixa orellana is being researched for application in aPDT. This protocol aims to determine the effectiveness of aPDT with Bixa orellana extract in deep caries lesions.
METHODS: A total of 160 teeth with deep occlusal dental caries will be selected and divided into 4 groups: G1 - control group (Caries removal with a low-speed drill); G2 - Partial Caries Removal with Papacarie™ (Fórmula e Ação, São Paulo, SP, Brazil); G3 - Partial Caries Removal with Papacarie™ and application Bixa orellana extract (20%) (Fórmula e Ação, São Paulo, SP, Brazil); G4 - Partial Caries Removal with Papacarie™ and application Bixa orellana extract (20%) with
LED (Valo Cordless Ultradent®, South Jordan, UT, USA) (aPDT). After treatment, all the teeth will be restored with glass ionomer cement and followed up clinically and radiographically, with evaluations at immediately, 1 week, and 1, 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The efficacy of treatments will be assessed with microbiological (colony-forming units, before and after carious tissue removal), radiographic (integrity of the periapical area and eventual changes in the radiolucent zones), and clinical examinations (retention of the restorative material in the cavity and occurrence of secondary caries), as well as with the time required for the procedures and the need for anesthesia during the procedures. In case data distribution is normal, analysis of variance (ANOVA) will be used for both the dependent and independent variables. In case the data distribution is not normal, the Friedman test will be used for the dependent variables. For independent variables, the Kruskal-Wallis test will be used.
CONCLUSIONS: Procedures using aPDT have been developed for the treatment of dental caries, but there are few controlled clinical trials in the literature confirming its efficacy.
BACKGROUND: This protocol is registered at ClinicalTrials.gov under the number NCT05236205 and it was first posted on 01/21/2022 and last updated on 05/10/2022.