Evaluation of Photodynamic Therapy in Pericoronitis: a Randomized, Controlled, Double-blind Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Microbiological analysis will be performed by RT-PCR for the bacterium Tannarella forsithia (Tf)
研究概览
简要总结
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 aim of this study is to evaluate the effectiveness of photodynamic therapy (PDT) with methylene blue in a 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. 34 healthy young patients with pericoronitis will be evaluated. Microbiological analysis will be performed by RT-PCR for the bacterium Tannarella forsithia (Tf).Gingival crevicular fluid will be collected to evaluate TNF-α, IL1-β, IL-6 and IL-8 and IL-10 by the Luminex assay. The variables will be pain (visual analogue scale), edema, trismus (digital caliper) and oral health-related quality of life (OHRQoL) will also be evaluated through the OHIP-14 questionnaire. The variables will be assessed at T1 (baseline)and T2 (4th day after PDT).
详细描述
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, 34 healthy young patients with pericoronitis will be evaluated. Patients will be randomized into the positive control group (G1) (n = 17): 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 = 17): 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), and T2 (4th day after PDT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
positive control group
G2 - 17 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
干预措施: irrigation /sterile saline (Combination Product)
positive control group
G2 - 17 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
干预措施: Methylene blue for oral use as photosensitizer (Combination Product)
positive control group
G2 - 17 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
干预措施: Photodynamic therapy (Combination Product)
experimental group
G1 - 17 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
干预措施: irrigation /sterile saline (Combination Product)
experimental group
G1 - 17 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
干预措施: Conventional methylene blue as photosensitizer (Combination Product)
experimental group
G1 - 17 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
干预措施: Photodynamic therapy (Combination Product)
结局指标
主要结局
Microbiological analysis will be performed by RT-PCR for the bacterium Tannarella forsithia (Tf)
时间窗: change from baseline, immediately after PDT and on fourth day after PDT
Sample collection for microbiological analysis Biofilm collection will be done at two points of the vestibular gingival sulcus of the lower third molar using minifive curettes. The collected material will be maintained in TE (Tris-EDTA), conditioned in microtubes and later transported for laboratory analysis in the Microbiology Laboratory of ICB-USP Prof. Marcia Mayer
次要结局
- pain assessed by Vas(change from baseline, immediately after PDT and on fourth day after PDT)
- edema assessed by measuring facial distance(change from baseline, immediately after PDT and on fourth day after PDT)
- Profile of cytokines Gingival crevicular fluid will be collected(change from baseline and on fourth day after PDT)
- trismus assessed by measuring bucal opening(change from baseline, immediately after PDT and on fourth day after PDT)
- OHRQoL assessed by ohip-14(change from baseline, immediately after PDT and on fourth day after PDT)
- position and classification of third molar(baseline)
研究者
Anna Carolina Ratto Tempestini Horliana
Clinical Professor
University of Nove de Julho