A Phase 1/2 interventional study of Teeth Brushing and Dental Flossing in Halitosis, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2024-04-01.
Sponsored by University of Nove de Julho · Phase 1/2, Interventional, and Treatment
Objective: To assess the effectiveness of antimicrobial photodynamic therapy (aPDT) employing an annatto-based (20%) dye combined with blue LED for the treatment of halitosis in mouth-breathing children. Methods: Fifty-two children six to twelve years of age with diagnoses of mouth breathing and halitosis (score of ≥ 3 on Breath Alert® portable breath meter) were randomly allocated to two groups (n = 26). Group 1: brushing, dental floss and aPDT applied to middle third of the dorsum of the tongue. Group 2: brushing, dental floss and tongue scraper. Breath meter results before, immediately after treatment as well as seven and 30 days after treatment were compared. The normality of the data will be determined using the Shapiro-Wilk test. Parametric data will be submitted to analysis of variance and nonparametric data will be compared using the Kruskal-Wallis test. The results of each treatment in the different periods of the study will be compared using the Wilcoxon test.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's enrollment of 52 is above the median of 45 across 79 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:
Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue.
Procedure: Teeth Brushing · Procedure: Dental Flossing · Radiation: Antimicrobial Photodynamic Therapy (aPDT)
Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping.
Procedure: Teeth Brushing · Procedure: Dental Flossing · Procedure: Tongue Scraping
All 52 participants were instructed through a lecture on how to perform toothbrushing with a fluoridated toothpaste (Colgate T®) and dental flossing three times per day after meals for 30 days. The Bass technique was taught, by which the bristles should be positioned at an approximate angle of 45º to the gingival pocket on both the free and proximal faces, with the performance of short, slightly circular vibrating movements.
All 52 participants were instructed to floss, 3 times a day after meals for 30 days.
Tongue scraping was performed by the same operator for all participants. Posteroanterior movements were performed with the scraper on the dorsum of the tongue, followed by the cleaning of the scraper with gauze. The procedure was performed ten times on each participant to standardize mechanical removal.
One session of aPDT was performed. The annatto photosensitizer was mixed at a concentration of 20% (Fórmula e Ação®, Brazil) in spray form, applied with a sufficient quantity to coat the middle third of the dorsum of the tongue (five sprays) and left for two minutes for incubation. The excess was removed with an aspirator. \|The surface of the tongue remained moist with the photosensitizer itself without the use of water. Six points were irradiated with a distance of 1 cm between points, considering the spread of the light and effectiveness of aPDT. The device was previously calibrated at a wavelength of 395-480 nm. Light was irradiated to ensure a beam area of 2 cm in diameter per point. Energy was 9.6 J and exposure time was 20 seconds per point.
Changes in Halimetry Results
The Breath Alert® device was used following the manufacturer's instructions and disinfected after each use. The device was shaken four or five times prior to each use to eliminate any residual odors. A "beep" was emitted upon opening the upper compartment of the device and a second "beep" was emitted when the participant blew into the frontal air input (air flow passage). After a third "beep", breath odor was measured and scored on a scale of 0 to 8 points. If the letter ''C'' appeared, indicating an error, the procedure was repeated. A score ≥ 2 points was considered indicative of halitosis.
Time frame: Baseline, immediately after treatment, after 7 days and after 30 days.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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