Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2023 Mar 4;24(1):165.
doi: 10.1186/s13063-023-07181-8.

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

Luiz Filipe Barbosa Martins  1   2 , Leandro Rodrigues de Sena  2 , Diego Martins de Paula  2 , Victor Pinheiro Feitosa  2 , Anna Carolina Ratto Tempestini Horliana  1 , Kristianne Porta Santos Fernandes  1 , Raquel Agnelli Mesquita-Ferrari  1 , Lara Jansiski Motta  1 , Marcela Leticia Leal Gonçalves  1   3 , Sandra Kalil Bussadori  4
Affiliations

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

Luiz Filipe Barbosa Martins et al. Trials. .

Abstract

Background: 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: A total of 160 teeth with deep occlusal dental caries will be selected and divided into 4 groups: G1 - control group (Caries removal with a low-speed drill); G2 - Partial Caries Removal with Papacarie™ (Fórmula e Ação, São Paulo, SP, Brazil); G3 - Partial Caries Removal with Papacarie™ and application Bixa orellana extract (20%) (Fórmula e Ação, São Paulo, SP, Brazil); G4 - Partial Caries Removal with Papacarie™ and application Bixa orellana extract (20%) with LED (Valo Cordless Ultradent®, South Jordan, UT, USA) (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, and 1, 3, 6, and 12 months. Dentin samples before and after treatment will be analyzed microbiologically. The efficacy of treatments will be assessed with microbiological (colony-forming units, before and after carious tissue removal), radiographic (integrity of the periapical area and eventual changes in the radiolucent zones), and clinical examinations (retention of the restorative material in the cavity and occurrence of secondary caries), as well as with the time required for the procedures and the need for anesthesia during the procedures. In case data distribution is normal, analysis of variance (ANOVA) will be used for both the dependent and independent variables. In case the data distribution is not normal, the Friedman test will be used for the dependent variables. For independent variables, the Kruskal-Wallis test will be used.

Discussion: Procedures using aPDT have been developed for the treatment of dental caries, but there are few controlled clinical trials in the literature confirming its efficacy.

Trial registration: This protocol is registered at ClinicalTrials.gov under the number NCT05236205 and it was first posted on 01/21/2022 and last updated on 05/10/2022.

Keywords: Bixa orellana; Dental caries; LED; Photodynamic therapy; aPDT.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT figure as recommended by the 2013 SPIRIT Statement, containing the description of procedures, interventions, assessments, and the study timeline
Fig. 2
Fig. 2
Sample size calculation used for this clinical research
Fig. 3
Fig. 3
Determination of the sample size for this clinical research in G*Power 3.1
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Cieplik F, Tabenski L, Buchalla W, Maisch T. Antimicrobial photodynamic therapy for inactivation of biofilms formed by oral key pathogens. Front Microbiol. 2014;5. 10.3389/fmicb.2014.00405. - PMC - PubMed
    1. Reis ACM, Regis WFM, Rodrigues LKA. Scientific evidence in antimicrobial photodynamic therapy: an alternative approach for reducing cariogenic bacteria. Photodiagn Photodyn Ther. 2019;26:179–189. doi: 10.1016/j.pdpdt.2019.03.012. - DOI - PubMed
    1. Silva ZS, França CM, Araújo Prates R, Botta SB, Ferrari RAM, Ana PA, et al. The effects of photodynamic therapy with blue light and papain-based gel associated with Urucum, on collagen and fibroblasts: a spectroscopic and cytotoxicity analysis. Lasers Med Sci. 2020;35:767–775. doi: 10.1007/s10103-019-02857-7. - DOI - PMC - PubMed
    1. Costa-Santos L, Silva-Júnior ZS, Sfalcin RA, Mota ACC d, Horliana ACRT, Motta LJ, et al. The effect of antimicrobial photodynamic therapy on infected dentin in primary teeth. Medicine. 2019;98:e15110. doi: 10.1097/MD.0000000000015110. - DOI - PMC - PubMed
    1. De Paula GS, Oliveira MC, Sales LS, Boriollo M, Rodrigues LKA, Nobre-dos-Santos M, et al. Antimicrobial photodynamic therapy mediated by methylene blue coupled to β-cyclodextrin reduces early colonizing microorganisms from the oral biofilm. Photodiagn Photodyn Ther. 2021;34:102283. doi: 10.1016/j.pdpdt.2021.102283. - DOI - PubMed

Publication types

Associated data