Evaluation of Photodynamic Therapy in Pericoronitis
Sleutelwoorden
Abstract
Omschrijving
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. If there is no adequate treatment at this stage, there may be evolution of the infectious condition so that antibiotic therapy is indicated. In order to reduce the chances of systemic dissemination of the infection and the use of antibiotics, it is mandatory to test effective treatments in the initial phase of pericoronitis aiming to avoid 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 cause bacterial resistance. The methylene blue used in PDT has been studied in a surfactant vehicle, which optimizes the formation of monomers increasing its antimicrobial action. Objective: The aim of this study is to evaluate the effectiveness of photodynamic therapy (PDT) with methylene blue in an surfactant vehicle in pericoronitis in the initial phase in healthy youngsters through microbiological, clinical and immunoregulatory 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 trial, 64 healthy young patients with pericoronitis will be evaluated. Patients will be randomized into the positive control group (G1) (n = 32): irrigation with sterile saline and photodynamic therapy (conventional methylene blue at 0.005% concentration and irradiation with low intensity laser λ = 660 nm, 9J per point and radiant exposure of 318 J / cm2), and the experimental group (G2) (n = 32): treatment identical to G1, however methylene blue will be delivered in a new formulation for oral use. Microbiological analysis will be performed by RT-PCR for the bacterium Tannerella forsithia (Tf).Non-stimulated saliva will be collected to evaluate TNF-α, IL1-β, IL-6 and IL-8 and IL-10 by Luminex assay. The pain (visual analogue scale), edema and buccal opening (digital caliper) and oral health-related quality of life (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).
Datums
| Laatst geverifieerd: | 11/30/2019 |
| Eerste ingediend: | 06/05/2018 |
| Geschatte inschrijving ingediend: | 06/30/2018 |
| Eerst geplaatst: | 07/02/2018 |
| Laatste update ingediend: | 12/08/2019 |
| Laatste update geplaatst: | 12/09/2019 |
| Werkelijke startdatum van het onderzoek: | 11/30/2019 |
| Geschatte primaire voltooiingsdatum: | 02/19/2020 |
| Geschatte voltooiingsdatum van het onderzoek: | 12/14/2020 |
Conditie of ziekte
Interventie / behandeling
Combination Product: irrigation /sterile saline
Combination Product: experimental group
Combination Product: positive control group
Combination Product: Photodynamic therapy
Fase
Armgroepen
| Arm | Interventie / behandeling |
|---|---|
| Experimental: experimental group G1 - 32 patients Photodynamic therapy with convention methylene blue as photosesintizer irrigation /sterile saline Conventional methylene blue as photosensitizer -Irrigation with 0,04mL of photosensitizer (0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes Photodynamic therapy -Device irradiation with low intensity laser λ = 660 nm, 9J per point and radiant 90 seconds | Combination Product: experimental group Irrigation with 0,04mL of photosensitizer (0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes |
| Active Comparator: positive control group G2 - 32 patients Photodynamic therapy with oral formula of methylene blue as photosesintizer, treatment identical to G1, however methylene blue will be delivered in a new formulation for oral use (patent aplicattion INPI BR1020170253902) irrigation /sterile saline Photodynamic therapy -Methylene blue for oral use as photosensitizer-Irrigation with 0,04mL of photosensitizer (0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes Device irradiation with low intensity laser λ = 660 nm, 9J per point and radiant 90 seconds | Combination Product: positive control group Irrigation with 0,04mL of photosensitizer(0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes |
Geschiktheidscriteria
| Leeftijden die in aanmerking komen voor studie | 13 Years Naar 13 Years |
| Geslachten die in aanmerking komen voor studie | All |
| Accepteert gezonde vrijwilligers | Ja |
| Criteria | Inclusion Criteria: - Patients should have at least one lower third partially visible molar in the oral cavity to be examined (Lower third molar erupted or partially erupted, with pericoronitis) - All patients, regardless of age, gender, cultural level or socioeconomic status may participate in the research. Exclusion Criteria: - patients allergic to methylene blue - pregnant or breastfeeding women, - those with local infection (e.g., pericoronitis or periodontal abscess) presence of purulent exudate, - those with fever (temperature above 37.8 C) - Patients who have used anti-inflammatory drugs or antibiotic medications in the last three months will also be excluded. |
Resultaat
Primaire uitkomstmaten
1. Microbiological analysis will be performed by RT-PCR for the bacterium Tannarella forsithia (Tf) [change from baseline, immediately after PDT and on fourth day after PDT]
Secundaire uitkomstmaten
1. Profile of cytokines Gingival crevicular fluid will be collected [change from baseline and on fourth day after PDT]
2. pain assessed by Vas [change from baseline, immediately after PDT and on fourth day after PDT]
3. edema assessed by measuring facial distance [change from baseline, immediately after PDT and on fourth day after PDT]
4. trismus assessed by measuring bucal opening [change from baseline, immediately after PDT and on fourth day after PDT]
5. OHRQoL assessed by ohip-14 [change from baseline, immediately after PDT and on fourth day after PDT]
6. position and classification of third molar [baseline]
