NCT05236205

Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions

Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions - Study Protocol for a Randomized, Controlled Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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 and analysis: A total of 160 teeth with deep occlusal dental caries will be selected and divided in 3 groups: G1 - control group (Caries removal with a lowspeed drill); G2 - Partial Caries Removal with Papacarie; G3 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%); G4 - Partial Caries Removal with Papacarie and application Bixa orellana extract (20%) with LED (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, 1, 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The data will be submitted to descriptive statistical analysis of the association between the categorical variables using the chi-square test and Fisher exact text. The Student t test and analysis of variance will be used for the comparison of mean signs and symptoms of reversible pulpitis. Pearson correlation coefficients will be calculated for the analysis of correlations among the continuous variables.

Conditions

• Caries

Interventions

Type	Name	Description
PROCEDURE	Caries removal with a lowspeed drill	1. Initial periapical and interproximal radiographs; 2. Prophylaxis with toothbrush and fluoride toothpaste; 3. Relative isolation with lip bumper, cotton roll, and aspirator; 4. Microbiological sampling with ear curette for standardization of volume of carious tissue; 5. Removal of carious dentin with carbide burs and manual instruments; 6. Additional microbiological sampling; 7. Clinical inspection of texture of remaining dentin with an exploratory probe; 8. Restoration with glass ionomer cement (Ketac Molar Easy Mix - 3M ESPE); 9. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months.
PROCEDURE	Partial removal of carious tissue with the administration of Papacarie™	1. Initial radiographs; 2. Relative isolation; 3. Microbiological sample with otoscope curette to standardize volume of carious tissue; 4. Application of Papacarie™ for 5 m inutes, removal of carious tissue around lateral walls of the cavity with noncutting curette and no removal of carious tissue on pulp floor; 5. Second microbiological sample of remaining dentin with curette; 6. Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; 7. Restoration with glass ionomer cement; 8. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.
PROCEDURE	Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%)	1. Initial radiographs; 2. Relative isolation; 3. Microbiological sample with otoscope curette to standardize volume of carious tissue; 4. Application of Papacarie™ with Bixa Orellana extract (20%) for 5 minutes, removal of carious tissue around lateral walls of the cavity with noncutting curette; 5. Irradiation of dental tissue for 1 minute on a single point; 6. Second microbiological sample of remaining dentin with curette; 7. Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; 8. Restoration with glass ionomer cement; 9. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.
PROCEDURE	Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)	1. Initial radiographs; 2. Relative isolation; 3. Microbiological sample with otoscope curette to standardize volume of carious tissue; 4. Application of Papacarie™ with Bixa Orellana extract (20%) for 5 minutes and the blue light-emitting diode (LED) irradiation with 440-480 nm. Removal of carious tissue around lateral walls of the cavity with noncutting curette; 5. Irradiation of dental tissue for 1 minute on a single point; 6. Second microbiological sample of remaining dentin with curette; 7. Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; 8. Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); 9. Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.

Timeline

• Start date: 2022-05-30
• Primary completion: 2022-11-30
• Completion: 2022-12-20
• First posted: 2022-02-11
• Last updated: 2022-05-17