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

University of Nove de Julho

Status and phase: Unknown; Phase 2

Conditions: Caries

Treatments: Procedure: Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%); Procedure: Caries removal with a lowspeed drill; Procedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT); Procedure: Partial removal of carious tissue with the administration of Papacarie™

Study type: Interventional

Funder types: Other

Identifiers

NCT05236205

UrucumCaries

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adequate health with no systemic conditions;
• Adequate cooperation;
• Clinically presenting at least 1 permanent molar with an acute, active caries on the dentin not surpassing 2/3 and only involving the occlusal face, with direct view and access as well as no clinical or radiographic signs of pulp involvement.

Exclusion criteria

• Systemic adverse health condition;
• Uncooperative behavior;
• Class II, III, IV, or V carious lesion based on Black classification;
• Clinically: caries involving enamel, deficient restorations, small carious lesions on dentin with no access for manual scalers, hidden caries, sign or symptom of pulp involvement, clinical impossibility of restoration;
• Radiographically: evidence of pulp involvement, carious lesion extending beyond 2/3 of dentin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 4 patient groups

Control Group

Experimental group

Description:

This group will receive the treatment of caries removal with a lowspeed drill (conventional treatment).

Treatment:

Procedure: Caries removal with a lowspeed drill

Papacarie

Experimental group

Description:

In this group, partial caries removal with Papacarie will be performed.

Treatment:

Procedure: Partial removal of carious tissue with the administration of Papacarie™

Papacarie and Bixa orellana extract

Experimental group

Description:

In this group, partial caries removal with Papacarie and the application of Bixa orellana extract (20%) will be performed.

Treatment:

Procedure: Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%)

Partial removal with aPDT

Experimental group

Description:

In this group, partial removal of the carious tissue will be performed, with Papacarie and the application of Bixa orellana extract (20%) with blue LED (aPDT).

Treatment:

Procedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)