CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
pdt experimental group +1 moredevice
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03973684
NCT03973684N/ACompleted

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

University of Nove de Julho·interventional·Posted Jun 4, 2019·Updated Jun 29, 2023

In Brief

A clinical study evaluating pdt experimental group and tongue scraper group for Halitosis. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHalitosis
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 4, 2019
Enrollment StartJul 1, 2019
Primary CompletionNov 1, 2019
Study CompletionFeb 1, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.1 years ago

Interventions

pdt experimental groupdevice

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 groupother

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