Completed

NCT Number: NCT03973684

Evaluation of Halitosis After Treatment With Photodynamic Therapy

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.

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Key information

Conditions

Halitosis Bronchial Diseases Bronchiectasis Mouth Diseases Pathological Conditions, Signs and Symptoms Periodontal Diseases Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anna Carolina R.T. Horliana

São Paulo, 11030-480, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pdt experimental group

Device

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.

tongue scraper group

Other

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

Primary outcomes

halitmetry (gas chromatography test)

Time frame: study completion an average of 1 year

The portable Oral ChromaTM will be used for the assessment of halitosis. Oral air collection will follow the manufactured guide lines (Oral Chroma Manual Instruction). A syringe will be placed in the patient's mouth with the plunger completely inserted and the participant will breathe through the nose with the mouth closed for one minute.The plunger will then be withdrawn to fill the chamber with air. The gas injection needle will be placed on the syringe and the plunger will be adjusted to 0.5 ml. This air will be injected into the input of the device in a single motion. This procedure will be done before, immediately after aPDT or scraper and after periodontal treatment.

Secondary outcomes

microbiological analysis

Time frame: before aPDT or scrapper , immediately after aPDT or scrapper , immediatly after periodontal treatment, 3 months later

collecting biofilm sample from the region of the lingual dorsum with swab and identification of the bacteria P. gingivalis and T. denticola. Sample will be transferred to sterile tubes with tris-EDTA (Ethylenediamine tetraacetic acid). The analysis will be performed by PCR (polymerase Chain reaction) real time

Other outcomes

Oral Health Related Quality of life (OHRQoL)

Time frame: before PDT or scrapper , 3 months after the halitosis treatment

oral health related quality of life will be measured using halt (halitosis associated life quality test). The patient will respond 20 questions in a lickert point scale that ranges from 0 till 5, considering higher results as worse quality of life.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2020
First posted: Jun 4, 2019
Registry last updated: Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed