Pericoronitis
Conditions
Keywords
third molar, pericoronitis, photodynamic therapy, microbiological analysis, laser, randomized controlled clinical study
Brief summary
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).
Detailed description
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).
Interventions
COMBINATION_PRODUCTirrigation /sterile saline
mechanical removal of bacteria with sterile saline
COMBINATION_PRODUCTConventional 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
COMBINATION_PRODUCTMethylene 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
COMBINATION_PRODUCTPhotodynamic therapy
Red laser for photodynamic therapy (Therapy XT,DMC,Sao Carlos,Sao Paulo,Brazil) Device irradiation with low intensity laser λ = 660 nm, 9J per point and radiant 90 seconds
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Endpoint Classification: Bio-equivalence Study Enrollment: 34 \[Anticipated\]
Eligibility
Sex/Gender
ALL
Age
13 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Profile of cytokines Gingival crevicular fluid will be collected | change from baseline and on fourth day after PDT | gingival crevicular fluid sample will be obtained. Samples will be kept in ice cube tubes. The saliva will be centrifuged at 4000 rpm for 10 minutes at -4 ° C and stored at -80 ° C for further analysis. Determination of plasma levels of the inflammatory markers TNF-α, IL1-β, IL-6 and IL-8 by Luminex assay |
| pain assessed by Vas | change from baseline, immediately after PDT and on fourth day after PDT | The pain will be assessed by applying a VAS visual analogic scale, consisting of a 100-mm line numbered in centimeters, with two closed ends. One end is labeled "0" and the other "100", meaning no pain and terrible pain, respectively. Each patient will be instructed to mark a vertical line with the point that best matches the intensity of pain during the evaluation. Instructions on marking will always be given to the patient by the same operator |
| edema assessed by measuring facial distance | change from baseline, immediately after PDT and on fourth day after PDT | The criteria for the determination of edema will follow pre-established measurements: (I) Corner of the eye to angle of the jaw (II) Tragus to the labial commissure and (III) Tragus to pogonion as described by Ustun, 2003. Edema will be the sum of three pre-established facial measures (using a digital caliper). |
| trismus assessed by measuring bucal opening | change from baseline, immediately after PDT and on fourth day after PDT | For evaluation of the presence of trismus the inter-incisor measurement (distance between the incisal edge of the maxillary central incisor and lower) will be used with a digital caliper (Mitutoyo Digimatic Caliper model, Japan). |
| OHRQoL assessed by ohip-14 | change from baseline, immediately after PDT and on fourth day after PDT | Oral health related quality of life: using OHIP-14 questionnaire we will assess the impact on HRQOL will be measured. This instrument consists of 14 items arranged in 7 factors: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. The answers are given in a 5-point Likert scale (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always). |
| position and classification of third molar | baseline | Position and classification of the lower third molars: the position of the teeth will be assessed by panoramic radiography, according to the classification of Pell and Gregory and Winter (1942), performed only by an evaluator, following the criteria of imaginary lines as proposed by Almendros-Marques , (2008). |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORAnna Carolina Ratto T Horliana, phd
Nove de Julho university (UNINOVE)
Outcome results
None listed