An interventional study of Pdt Photodynamic Therapy and tongue scrapper in Halitosis, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy or G2-cleaning of the tongue with a tongue scraper . Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola
Halitosis is an unpleasant odor that emanating from the mouth. A recent metanalysis shows worldwide trend towards a rise in halitosis prevalence. Studies show halitosis returns in a week after treatment with photodynamic therapy (PDT). Probably, bacteria residing in the periodontal sulcus could recolonize the dorsum of the tongue. To date, there are no study in adult population that associate halitosis and periodontal treatment with follow-up evaluation. The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants (n=40) with halitosis 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). Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola. The evaluation of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and three months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile (OHIP-14) Comparisons will be made with ANOVA test, with the level of significance of 5 %. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults.
90 studies on the registry are indexed under Halitosis; 18 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 77 interventional studies indexed under Halitosis.
Browse Halitosis studies →University of Nove de Julho is the lead sponsor of 246 studies on the registry; 52 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
G1-20 patients Photodynamic therapy with methylene blue as photosensitizer device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) per point (6 points) and radiant 90 seconds. Photosensitiser (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.
Device: Pdt Photodynamic Therapy
G2-20 patients 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
Other: tongue scrapper
device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) 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 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
halitosis measurement (gas chromatography test)
The portable Oral Chroma 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. This procedure will be repeated. 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 PDT or scraper and after periodontal treatment.
Time frame: through study completion on average of one year
microbiological analysis
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 ethylenediaminetetraacetic acid (tris-EDTA). The analysis will be performed by PCR (polymerase Chain reaction) real time
Time frame: through study completion on average of one year
Plan to share: No
Ran from Jan 2019 to primary completion in Nov 2019, 10 months.
Of 33 non-industry interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 10 months is close to that.
Counting every sponsor, half of 41 studies reached it within 10 months; a quarter within 3 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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