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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Experimental | This group will receive the treatment of caries removal with a lowspeed drill (conventional treatment). |
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| Papacarie | Experimental | In this group, partial caries removal with Papacarie will be performed. |
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| Papacarie and Bixa orellana extract | Experimental | In this group, partial caries removal with Papacarie and the application of Bixa orellana extract (20%) will be performed. |
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| Partial removal with aPDT | Experimental | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caries removal with a lowspeed drill | Procedure |
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| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36870982 | Derived | Martins LFB, de Sena LR, de Paula DM, Feitosa VP, Horliana ACRT, Fernandes KPS, Mesquita-Ferrari RA, Motta LJ, Goncalves MLL, Bussadori SK. 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. Trials. 2023 Mar 4;24(1):165. doi: 10.1186/s13063-023-07181-8. |
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The clinical evaluations of the carious tissue removal, as well as the microbiological and radiographic analyses, will be performed by examiners blinded to the treatments performed on each tooth.
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| Partial removal of carious tissue with the administration of Papacarie™ | Procedure |
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| Partial removal of carious tissue with the administration of Papacarie™ and application of Bixa Orellana extract (20%) | Procedure |
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| Partial removal of carious tissue with the administration of Papacarie™, application of Bixa Orellana extract (20%) and LED (aPDT) | Procedure |
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| 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;
| 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:
| During the procedure. |