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Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study

INTRODUCTION: Pericoronitis is a common disease in the eruption phase of third molars, sometimes debilitating, with an impact on the quality of life. The most indicated treatment in the initial phase is the irrigation for cleanliness of the region. In order to reduce the chances of systemic dissemin...

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Autores principales: Schalch, Tânia Oppido, Palmieri, Michelle, Longo, Priscila Larcher, Braz-Silva, Paulo Henrique, Tortamano, Isabel Peixoto, Michel-Crosato, Edgard, Mayer, Marcia Pinto Alves, Jorge, Waldyr Antonio, Bussadori, Sandra Kalil, Pavani, Christiane, Negreiros, Renata Matalon, Horliana, Anna Carolina Ratto Tempestini
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Wolters Kluwer Health 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6831272/
https://www.ncbi.nlm.nih.gov/pubmed/31027098
http://dx.doi.org/10.1097/MD.0000000000015312
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author Schalch, Tânia Oppido
Palmieri, Michelle
Longo, Priscila Larcher
Braz-Silva, Paulo Henrique
Tortamano, Isabel Peixoto
Michel-Crosato, Edgard
Mayer, Marcia Pinto Alves
Jorge, Waldyr Antonio
Bussadori, Sandra Kalil
Pavani, Christiane
Negreiros, Renata Matalon
Horliana, Anna Carolina Ratto Tempestini
author_facet Schalch, Tânia Oppido
Palmieri, Michelle
Longo, Priscila Larcher
Braz-Silva, Paulo Henrique
Tortamano, Isabel Peixoto
Michel-Crosato, Edgard
Mayer, Marcia Pinto Alves
Jorge, Waldyr Antonio
Bussadori, Sandra Kalil
Pavani, Christiane
Negreiros, Renata Matalon
Horliana, Anna Carolina Ratto Tempestini
author_sort Schalch, Tânia Oppido
collection PubMed
description INTRODUCTION: Pericoronitis is a common disease in the eruption phase of third molars, sometimes debilitating, with an impact on the quality of life. The most indicated treatment in the initial phase is the irrigation for cleanliness of the region. In order to reduce the chances of systemic dissemination of the infection and antibiotics use, it is mandatory to test effective treatments in the initial phase of pericoronitis avoiding the evolution of the infectious disease. Photodynamic therapy (PDT) is an interesting alternative because it is an effective antimicrobial treatment that is easy to perform and does not select bacterial resistance. The methylene blue (MB) used in PDT has been studied in an oral formulation, which optimizes the formation of monomers increasing its antimicrobial action. OBJECTIVE: The aim of this study is to evaluate the effectiveness of PDT with MB in an astringent vehicle in pericoronitis on the initial phase in healthy patients through microbiological, clinical, and immune response. The impact of pericoronitis on oral health-related quality of life (OHRQoL) of these patients will also be evaluated. METHOD: In this randomized, controlled, double-blind clinical bioequivalence protocol, 64 healthy patients with pericoronitis will be evaluated. Patients will be randomized into the positive control group (G1) (n = 32): irrigation with sterile saline and PDT (conventional MB at 0.005% concentration and irradiation with low intensity laser λ = 660 nm, 9J per point and radiant exposure of 318 J/cm(2)), and the experimental group (G2) (n = 32): treatment identical to G1, however, MB will be delivered in a new formulation for oral use. Microbiological analysis will be performed by RT-PCR for the bacterium Tannerella forsythia. Gingival crevicular fluid and saliva will be collected to evaluate cytokines by Luminex assay (Luminex Corporation, Austin, TX). The pain (visual analogue scale), swelling and buccal opening (digital caliper), and OHRQoL will also be evaluated through the OHIP-14 questionnaire. The variables will be evaluated in T1 (baseline), T2 (immediately after PDT), and T3 (4th day after PDT). Registration: clinicaltrials.gov NCT 03576105. Registered in July 2018.
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spelling pubmed-68312722019-11-19 Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study Schalch, Tânia Oppido Palmieri, Michelle Longo, Priscila Larcher Braz-Silva, Paulo Henrique Tortamano, Isabel Peixoto Michel-Crosato, Edgard Mayer, Marcia Pinto Alves Jorge, Waldyr Antonio Bussadori, Sandra Kalil Pavani, Christiane Negreiros, Renata Matalon Horliana, Anna Carolina Ratto Tempestini Medicine (Baltimore) 5900 INTRODUCTION: Pericoronitis is a common disease in the eruption phase of third molars, sometimes debilitating, with an impact on the quality of life. The most indicated treatment in the initial phase is the irrigation for cleanliness of the region. In order to reduce the chances of systemic dissemination of the infection and antibiotics use, it is mandatory to test effective treatments in the initial phase of pericoronitis avoiding the evolution of the infectious disease. Photodynamic therapy (PDT) is an interesting alternative because it is an effective antimicrobial treatment that is easy to perform and does not select bacterial resistance. The methylene blue (MB) used in PDT has been studied in an oral formulation, which optimizes the formation of monomers increasing its antimicrobial action. OBJECTIVE: The aim of this study is to evaluate the effectiveness of PDT with MB in an astringent vehicle in pericoronitis on the initial phase in healthy patients through microbiological, clinical, and immune response. The impact of pericoronitis on oral health-related quality of life (OHRQoL) of these patients will also be evaluated. METHOD: In this randomized, controlled, double-blind clinical bioequivalence protocol, 64 healthy patients with pericoronitis will be evaluated. Patients will be randomized into the positive control group (G1) (n = 32): irrigation with sterile saline and PDT (conventional MB at 0.005% concentration and irradiation with low intensity laser λ = 660 nm, 9J per point and radiant exposure of 318 J/cm(2)), and the experimental group (G2) (n = 32): treatment identical to G1, however, MB will be delivered in a new formulation for oral use. Microbiological analysis will be performed by RT-PCR for the bacterium Tannerella forsythia. Gingival crevicular fluid and saliva will be collected to evaluate cytokines by Luminex assay (Luminex Corporation, Austin, TX). The pain (visual analogue scale), swelling and buccal opening (digital caliper), and OHRQoL will also be evaluated through the OHIP-14 questionnaire. The variables will be evaluated in T1 (baseline), T2 (immediately after PDT), and T3 (4th day after PDT). Registration: clinicaltrials.gov NCT 03576105. Registered in July 2018. Wolters Kluwer Health 2019-04-26 /pmc/articles/PMC6831272/ /pubmed/31027098 http://dx.doi.org/10.1097/MD.0000000000015312 Text en Copyright © 2019 the Author(s). Published by Wolters Kluwer Health, Inc. http://creativecommons.org/licenses/by/4.0 This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0
spellingShingle 5900
Schalch, Tânia Oppido
Palmieri, Michelle
Longo, Priscila Larcher
Braz-Silva, Paulo Henrique
Tortamano, Isabel Peixoto
Michel-Crosato, Edgard
Mayer, Marcia Pinto Alves
Jorge, Waldyr Antonio
Bussadori, Sandra Kalil
Pavani, Christiane
Negreiros, Renata Matalon
Horliana, Anna Carolina Ratto Tempestini
Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study
title Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study
title_full Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study
title_fullStr Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study
title_full_unstemmed Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study
title_short Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study
title_sort evaluation of photodynamic therapy in pericoronitis: protocol of randomized, controlled, double-blind study
topic 5900
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6831272/
https://www.ncbi.nlm.nih.gov/pubmed/31027098
http://dx.doi.org/10.1097/MD.0000000000015312
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