Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children

Halitosis Clinical Trial

Official title:

Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05590897
• Other study ID #: MouthBreathing
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2023
• Est. completion date: December 20, 2023

Study information

• Verified date: March 2024
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 20, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

Inclusion Criteria:

• Diagnosis of mouth breathing (performed using the calibrated Glatzel mirror test, water retention test and a questionnaire);
• Halitosis presenting a score equal or greater than 2, in the Breath Alert analysis.

Exclusion Criteria:

• Nasal breathers;
• Dentofacial anomalies (such as cleft lip, cleft palate and nasopalatine);
• Undergoing orthodontic and/or orthopedic treatment;
• Undergoing cancer treatment;
• Systemic alterations (gastrointestinal, renal, hepatic);
• Under antibiotic treatment for up to 1 month before the research;
• Fissured or grooved tongue.

Related Conditions & MeSH terms

• Halitosis
• Mouth Breathing

Intervention

Procedure:
• Teeth Brushing
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.
• Dental Flossing
All 52 participants were instructed to floss, 3 times a day after meals for 30 days.
• Tongue Scraping
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.

Radiation:
• Antimicrobial Photodynamic Therapy (aPDT)
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.

Locations

Country	Name	City	State
Brazil	Universidade Metropolitana de Santos - UNIMES	Santos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, immediately after treatment, after 7 days and after 30 days.