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Evaluation of Photodynamic Therapy in Pericoronitis

NCT03576105 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-06-29

No results posted yet for this study

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).

Conditions

  • Pericoronitis

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

Sponsors & Collaborators

  • University of Nove de Julho

    lead OTHER

Principal Investigators

  • Anna Carolina Ratto T Horliana, phd · Nove de Julho university (UNINOVE)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2024-04-20
Completion
2024-06-15

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03576105 on ClinicalTrials.gov