Assessment of Photodynamic Therapy With Annatto and Led for the Treatment of Halitosis in Mouth-Breathing Children: Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University of Nove de Julho
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Changes in Halimetry Results
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The Breath Alert, as the device that will be used to determine the presence of halitosis, is blinded to groups/participants.
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Antimicrobial Photodynamic Therapy Group
Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue.
Intervention: Teeth Brushing (Procedure)
Antimicrobial Photodynamic Therapy Group
Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue.
Intervention: Dental Flossing (Procedure)
Antimicrobial Photodynamic Therapy Group
Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue.
Intervention: Antimicrobial Photodynamic Therapy (aPDT) (Radiation)
Tongue Scraping Group
Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping.
Intervention: Teeth Brushing (Procedure)
Tongue Scraping Group
Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping.
Intervention: Dental Flossing (Procedure)
Tongue Scraping Group
Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping.
Intervention: Tongue Scraping (Procedure)
Outcomes
Primary Outcomes
Changes in Halimetry Results
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho