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COMPLETED
NCT03576105
NA

Evaluation of Photodynamic Therapy in Pericoronitis

Sponsor: University of Nove de Julho

View on ClinicalTrials.gov

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).

Official title: Evaluation of Photodynamic Therapy in Pericoronitis: a Randomized, Controlled, Double-blind Clinical Study

Key Details

Gender

All

Age Range

13 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2019-12-01

Completion Date

2024-06-15

Last Updated

2026-07-29

Healthy Volunteers

Yes

Conditions

Interventions

COMBINATION_PRODUCT

irrigation /sterile saline

mechanical removal of bacteria with sterile saline

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

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

COMBINATION_PRODUCT

Photodynamic 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

Locations (1)

Nove de Julho University

São Paulo, Brazil