NCT03973684

Evaluation of Halitosis After Treatment With Photodynamic Therapy

Evaluation of Halitosis After Treatment With Photodynamic Therapy Randomized and Controlled Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Nove de Julho · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Halitosis is the term used to define an unpleasant odor emanating from the mouth. Some lung diseases, such as bronchiectasis, are among the extra-oral causes of this condition. However, no studies have evaluated the reasons and treatment of halitosis in the population of adults with bronchiectasis. Methods and analysis: A randomized, controlled trial is proposed. Halitosis will be evaluated based on the measurement of volatile sulfur compounds (VSC) using gas chromatography. The participants (n=40) with halitosis and bronchiectasis will be randomized into two groups: G1-treatment with photodynamic therapy (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20). After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria P. gingivalis and T. denticola. If the halitosis persists, the participants will receive periodontal treatment. The evaluation of halitosis and the microbiological analysis will be repeated. If the halitosis is solved, the participants will return after three months for an additional evaluation. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in healthy older adults and those with bronchiectasis.

Detailed description

A single-center, randomized, controlled, single-blind clinical trial was designed in accordance with the criteria recommended for interventional trials in the SPIRIT Statement. The project for the proposed study received approval from the Human Research Ethics Committee o fNove de Julho University(certificate number: 1057901). Selection of individuals - characterization of sample - Two groups will be composed of adults in treatment at the dental clinic of Nove de Julho University. After verbal and written explanations of the study, those who agree to participate will sign a statement of informed consent approved by the Human Research Ethics Committee of Nove de Julho University. The study will be conducted in compliance with the precepts stipulated in the Declaration of Helsinki (revised in Fortaleza, Brazil, 2013).

Conditions

• Halitosis

Interventions

Type	Name	Description
DEVICE	pdt experimental group	G1-40 patients Photodynamic therapy with methylene blue as photosensitizer device irradiation with low intensity laser (wave length = 660 nm) 9J (Jaules) per point(6 points) and radiant 90 seconds PS will be applied in sufficient quantity to cover the middle third and back of the tongue and wait for 5 minutes.six points with the distances of 1 cm between them will be irradiated.
OTHER	tongue scraper group	Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum. in order to promote the mechanical removal of tongue coating

Timeline

• Start date: 2019-07-01
• Primary completion: 2019-11-01
• Completion: 2020-02-01
• First posted: 2019-06-04
• Last updated: 2023-06-29

Locations

1 site across 1 country: Brazil