Antimicrobial Photodynamic Therapy as an Adjunct for Management of Deep Caries Lesions
- Conditions
- Caries
- Interventions
- 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: Caries removal with a lowspeed drillProcedure: Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT)
- Registration Number
- NCT05236205
- Lead Sponsor
- University of Nove de Julho
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Papacarie Partial removal of carious tissue with the administration of Papacarie™ In this group, partial caries removal with Papacarie will be performed. Papacarie and Bixa orellana extract Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%) In this group, partial caries removal with Papacarie and the application of Bixa orellana extract (20%) will be performed. Control Group Caries removal with a lowspeed drill This group will receive the treatment of caries removal with a lowspeed drill (conventional treatment). Partial removal with aPDT Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (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).
- Primary Outcome Measures
Name Time Method Changes in Microbiological Evaluation Baseline and immediately after treatment. 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.
- Secondary Outcome Measures
Name Time Method Evaluation of time required for procedure During the 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.
Changes in Radiographic evaluation Baseline, immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment. 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.
Evaluation of need for local anesthesia during intervention During the procedure. 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.
Degree of pain/discomfort of children during procedure During the 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:
1. No pain.
2. Mild pain.
3. Moderate pain.
4. A little worse pain.
5. Strong pain.
6. Worst pain.Changes in Clinical Evaluation Immediately after treatment, 1 week, 1, 3, 6, and 12 months after treatment. 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;
1. = present; small marginal defects measuring less than 0.5mm in depth; no need for repair;
2. = present; small marginal defects measuring 0.5mm to 1mm in depth; need for repair;
3. = present; large marginal defects measuring 1 or more mm in depth; need for repair;
4. = absent; restoration nearly or completely lost; need for treatment;
5. = absent; additional treatment having been performed for some reason;
6. = tooth absent for any reason;
7. = present; surface wear measuring less than 0.5mm in depth; no need for replacement;
8. = present; surface wear greater than 0.5mm in depth; need for replacement;
9. = impossible to diagnose.