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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries
• Intervention / Treatment: Procedure: Caries removal with a lowspeed drill; Procedure: Partial removal of carious tissue with the administration of Papacarie™; Procedure: Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%); Procedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control Group; This group will receive the treatment of caries removal with a lowspeed drill (conventional treatment).	Procedure: Caries removal with a lowspeed drill; Initial periapical and interproximal radiographs;; Prophylaxis with toothbrush and fluoride toothpaste;; Relative isolation with lip bumper, cotton roll, and aspirator;; Microbiological sampling with ear curette for standardization of volume of carious tissue;; Removal of carious dentin with carbide burs and manual instruments;; Additional microbiological sampling;; Clinical inspection of texture of remaining dentin with an exploratory probe;; Restoration with glass ionomer cement (Ketac Molar Easy Mix - 3M ESPE);; Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months.
Experimental: Papacarie; In this group, partial caries removal with Papacarie will be performed.	Procedure: Partial removal of carious tissue with the administration of Papacarie™; Initial radiographs;; Relative isolation;; Microbiological sample with otoscope curette to standardize volume of carious tissue;; 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;; Second microbiological sample of remaining dentin with curette;; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe;; Restoration with glass ionomer cement;; Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.
Experimental: Papacarie and Bixa orellana extract; In this group, partial caries removal with Papacarie and the application of Bixa orellana extract (20%) will be performed.	Procedure: Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%); Initial radiographs;; Relative isolation;; Microbiological sample with otoscope curette to standardize volume of carious tissue;; Application of Papacarie™ with Bixa Orellana extract (20%) for 5 minutes, removal of carious tissue around lateral walls of the cavity with noncutting curette;; Irradiation of dental tissue for 1 minute on a single point;; Second microbiological sample of remaining dentin with curette;; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe;; Restoration with glass ionomer cement;; Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.
Experimental: Partial removal with aPDT; 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).	Procedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT); Initial radiographs;; Relative isolation;; Microbiological sample with otoscope curette to standardize volume of carious tissue;; 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;; Irradiation of dental tissue for 1 minute on a single point;; Second microbiological sample of remaining dentin with curette;; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe;; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE);; Clinical and radiographic follow-up immediately, 1 week, 1, 3, 6, and 12 months after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Microbiological Evaluation	A sample of caries-affected dentin will be taken from each selected tooth before the removal of the carious tissue. All procedures will be performed in duplicate, and the mean of the counts will be calculated. The results will be expressed in CFU of SM and LB as well as in proportion of streptococcus (% S/VM), SM group (% SM/VM and lactobacilli (% LB/VM) in relation to the total of VM. Immediately after the removal of the carious tissue, samples of the remaining dentin will be taken with a Meyhoefer auricular n° 2 curette and the procedures will be repeated.	Baseline and immediately after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Radiographic evaluation	Periapical and interproximal radiographs will be taken initially and immediately after the procedure. Subsequently, follow up will be performed at immediately, 1 week, 1, 3, 6, and 12 months for the evaluation of optical density on the radiographs and the visual clinical interpretation of the remaining dentin as well as the evaluation using the radiographic subtraction method. The radiographic images from the different evaluation times will be scanned for the analysis of differences in density. For such, an specific program will be used.	Baseline, immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
Evaluation of time required for procedure	The time required for each procedure will be measured using a digital stopwatch (Kenko, Hong Kong) in minutes and seconds from the onset of treatment until the complete removal of the carious tissue. The time will be recorded on a specific chart for analysis.	During the procedure.
Evaluation of need for local anesthesia during intervention	All interventions will be initiated without the prior administration of local anesthesia. The children will be told that anesthesia could be administered at any time during the intervention. The need for anesthesia, or not, will be recorded.	During the procedure.
Changes in Clinical Evaluation	The criteria used of the evaluation will be the retention of the restorative material in the cavity and the occurrence of secondary caries. Digital photographs of the restorations will also be taken and serve to complement the clinical and radiographic findings. 0 = present; no defects; = present; small marginal defects measuring less than 0.5mm in depth; no need for repair;; = present; small marginal defects measuring 0.5mm to 1mm in depth; need for repair;; = present; large marginal defects measuring 1 or more mm in depth; need for repair;; = absent; restoration nearly or completely lost; need for treatment;; = absent; additional treatment having been performed for some reason;; = tooth absent for any reason;; = present; surface wear measuring less than 0.5mm in depth; no need for replacement;; = present; surface wear greater than 0.5mm in depth; need for replacement;; = impossible to diagnose.	Immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment.
Degree of pain/discomfort of children during procedure	A face scale with different expressions will be used and the child will be asked to point to the expression that most corresponds to his/her degree of pain/discomfort. Interpretation of face scale: No pain.; Mild pain.; Moderate pain.; A little worse pain.; Strong pain.; Worst pain.	During the procedure.

Collaborators and Investigators

• Sponsor: University of Nove de Julho

Study record dates

Study Major Dates

• Study Start (Anticipated): May 30, 2022
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): December 20, 2022

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (Actual): February 11, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 10, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: UrucumCaries

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No