Evaluation of Halitosis After Treatment With Photodynamic Therapy

University of Nove de Julho

Status: Completed

Conditions: Halitosis

Treatments: Device: pdt experimental group; Other: tongue scraper group

Study type: Interventional

Funder types: Other

Identifiers

NCT03973684

halitosis

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• every age in both genders
• With diagnosis of bronchiectasis (experimental group)
• Patients clinically stable (compensated) (control group)
• Have more than 10 teeth
• Do not have any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
• With positive halitosis, SH2 level >112 ppb

Exclusion criteria

• Smokers or ex-smokers for less than 5 years
• Patients diagnosed with cystic fibrosis
• Patients with hypersensitivity to the photosensitizer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

aPDT group

Active Comparator group

Description:

G1- 40 patient 40 patients will be included in this group. One section of Pdt will be performed with the photosensitizer (PS). PS will be applied in sufficience 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. The apparatus shall be precalibrated at wavelength 660nm for 90 seconds per point.

Treatment:

Other: tongue scraper group

Device: pdt experimental group

experimental tongue scrapper group

Experimental group

Description:

40 patients will be included in this 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

Treatment:

Other: tongue scraper group

Device: pdt experimental group