Evaluation of Halitosis After Treatment With Photodynamic Therapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-02-01

Brief Summary

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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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Detailed Description

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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

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Halitosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

bio-equivalence study enrollment: 80

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Double (Participant ,investigator) Double Blind(Subject,Caregiver,Investigator,Outcomes Assessor)

Study Groups

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aPDT group

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.

Group Type ACTIVE_COMPARATOR

pdt experimental group

Intervention Type 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

Intervention Type 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

experimental tongue scrapper group

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

Group Type EXPERIMENTAL

pdt experimental group

Intervention Type 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

Intervention Type 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

Interventions

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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.

Intervention Type DEVICE

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

Intervention Type OTHER

Eligibility Criteria

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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