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

Phase 1

Completed

• Conditions: Halitosis

• Registration Number: NCT05590897
• Lead Sponsor: University of Nove de Julho

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-19
• Study First Submitted QC: 2022-10-19
• Study First Posted: 2022-10-21
• Study Start: 2023-02-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes in Halimetry Results	Baseline, immediately after treatment, after 7 days and after 30 days.	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.

Trial Locations

Locations (1)

Universidade Metropolitana de Santos - UNIMES; 🇧🇷 Santos, São Paulo, Brazil