Investigation on the effect of antimicrobial photodynamic therapy as an adjunct for management of deep caries lesions-study protocol for a randomized, parallel groups, controlled clinical trial
Abstract
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…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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