Clinical trial

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

Name
pericoronitis
Description
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).
Trial arms
Trial start
2019-12-01
Estimated PCD
2024-04-20
Trial end
2024-06-15
Treatment
irrigation /sterile saline
mechanical removal of bacteria with sterile saline
Arms:
experimental group, positive control group
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
Arms:
experimental group
Other names:
photodynamic therapy with conventional methylene blue
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
Arms:
positive control group
Other names:
photodynamic therapy with methylene blue for oral use
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
Arms:
experimental group, positive control group
Other names:
PDT
Size
34
Primary endpoint
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
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Endpoint Classification: Bio-equivalence Study Enrollment: 34 \\[Anticipated\\]', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 34, 'type': 'ESTIMATED'}}
Updated at
2023-06-29

1 organization

4 products

1 indication

Indication
Pericoronitis