Clinical trial NCT03576105: Evaluation of Photodynamic Therapy in Pericoronitis
Official title: Evaluation of Photodynamic Therapy in Pericoronitis: a Randomized, Controlled, Double-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pericoronitis
Keywords: third molar
pericoronitis
photodynamic therapy
microbiological analysis
laser
randomized controlled clinical study
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2018-07-03
Enrollment: 34
Sex: ALL
Minimum age (years): 13
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Endpoint Classification: Bio-equivalence Study Enrollment: 34 \[Anticipated\]
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Microbiological analysis will be performed by RT-PCR for the bacterium Tannarella forsithia (Tf)
timeFrame: change from baseline, immediately after PDT and on fourth day after PDT
Secondary outcomes:
measure: Profile of cytokines Gingival crevicular fluid will be collected
timeFrame: change from baseline and on fourth day after PDT
measure: pain assessed by Vas
timeFrame: change from baseline, immediately after PDT and on fourth day after PDT
measure: edema assessed by measuring facial distance
timeFrame: change from baseline, immediately after PDT and on fourth day after PDT
measure: trismus assessed by measuring bucal opening
timeFrame: change from baseline, immediately after PDT and on fourth day after PDT
measure: OHRQoL assessed by ohip-14
timeFrame: change from baseline, immediately after PDT and on fourth day after PDT
measure: position and classification of third molar
timeFrame: baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Nove de Julho University
Study officials:
affiliation: Nove de Julho university (UNINOVE)
name: Anna Carolina Ratto T Horliana, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: da Silva T, da Silva FC, Gomes AO, Viana AO, Goncalves MLL, Rodrigues MFSD, Horliana ACRT, da Silva DFT, Chavantes MC, Fragoso YD, Branco LP, Motta LJ, Fernandes KPS, Mesquita-Ferrari RA, Bussadori SK. Effect of photobiomodulation treatment in the sublingual, radial artery region, and along the spinal column in individuals with multiple sclerosis: Protocol for a randomized, controlled, double-blind, clinical trial. Medicine (Baltimore). 2018 May;97(19):e0627. doi: 10.1097/MD.0000000000010627.
citation: Sobral APT, Godoy CLH, Fernandes KPS, Bussadori SK, Ferrari RAM, Horliana ACRT, Monken SF, Motta LJ. Photomodulation in the treatment of chronic pain in patients with temporomandibular disorder: protocol for cost-effectiveness analysis. BMJ Open. 2018 May 5;8(5):e018326. doi: 10.1136/bmjopen-2017-018326.
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citation: Okamoto CB, Motta LJ, Prates RA, da Mota ACC, Goncalves MLL, Horliana ACRT, Mesquita Ferrari RA, Fernandes KPS, Bussadori SK. Antimicrobial Photodynamic Therapy as a Co-adjuvant in Endodontic Treatment of Deciduous Teeth: Case Series. Photochem Photobiol. 2018 Jul;94(4):760-764. doi: 10.1111/php.12902. Epub 2018 Apr 30.
citation: Belotto RA, Chavantes MC, Tardivo JP, Euzebio Dos Santos R, Fernandes RCM, Horliana ACRT, Pavani C, Teixeira da Silva DF. Therapeutic comparison between treatments for Vulvar Lichen Sclerosus: study protocol of a randomized prospective and controlled trial. BMC Womens Health. 2017 Aug 10;17(1):61. doi: 10.1186/s12905-017-0414-y.
citation: Schalch TO, Palmieri M, Longo PL, Braz-Silva PH, Tortamano IP, Michel-Crosato E, Mayer MPA, Jorge WA, Bussadori SK, Pavani C, Negreiros RM, Horliana ACRT. Evaluation of photodynamic therapy in pericoronitis: Protocol of randomized, controlled, double-blind study. Medicine (Baltimore). 2019 Apr;98(17):e15312. doi: 10.1097/MD.0000000000015312.