CompletedNot Applicable

Evaluation of Photodynamic Therapy in Pericoronitis

Brazil34 participantsStarted 2019-12-01

Plain-language 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).

Who can participate

Age range

13 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT03576105

SponsorUniversity of Nove de Julho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-20

View on ClinicalTrials.gov More Pericoronitis trials