Comparative Study Between Photodynamic Therapy and the Use of Probiotics in the Reduction of Halitosis in Mouth Breathing Children

Study Overview
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Brief Summary
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Halitosis is a term that defines any odor or malodour coming from the oral cavity, which may have local or systemic origin. One of the causes of local or oral odor is the reduction of salivary flow and oral dryness, also considered as one of the most common complaints among mouth breathers. This project aims to verify the effectiveness of antimicrobial photodynamic therapy (aPDT) and the use of probiotics in the treatment of halitosis in mouth breathing children. For the study, 52 children aged between 7 and 12 years who, after an interview and initial clinical examination, have the diagnosis of mouth breathing and halitosis, will be selected. Participants will be divided into 4 groups. Group 1: treatment with brushing, dental floss and tongue scraper; Group 2: brushing, dental floss and aPDT applied to the dorsum and middle thirds of the tongue; Group 3: brushing, dental floss and probiotics; Group 4: brushing, dental floss, aPDT and probiotics. In all groups, halimetry and microbiological analysis of the tongue coating will be performed before, immediately after treatment and seven days after treatment. The quantitative analysis will be carried out by counting bacteria by units that form colonies per milliliter. The normality of the data will be verified through the Shapiro-Wilk test, and, in the case of normality, the Analysis of Variance (ANOVA), and, in the case of non-parametric data, the Kruskal-Wallis test. To analyze the results of each treatment in the two periods of the study, the Wilcoxon test will be used.

Official Title
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Comparative Study Between Photodynamic Therapy and the Use of Probiotics in the Reduction of Halitosis in Mouth Breathing Children - Study Protocol for a Randomized Controlled Clinical Trial

Conditions
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Halitosis

Intervention / Treatment
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* Procedure: Teeth Brushing
* Procedure: Dental Flossing
* Procedure: Tongue Scraping
* Radiation: Antimicrobial Photodynamic Therapy (aPDT)
* Dietary Supplement: Probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of mouth breathing (a standardized questionnaire will be used to assess the habit of mouth breathing); 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.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tongue Scraping Group<br>Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping. | Procedure: Teeth Brushing<br>* All 52 participants will be instructed to brush with toothpaste containing amine fluoride in its composition (Elmex®), 3 times a day after meals for 10 days.<br>Procedure: Dental Flossing<br>* All 52 participants will be instructed to floss, 3 times a day after meals for 10 days.<br>Procedure: Tongue Scraping<br>* Tongue scraping will be performed by the same operator on all participants. Posteroanterior movements will be performed with the scraper on the lingual dorsum, followed by cleaning the scraper with gauze. This procedure will be carried out ten times in each patient, with the aim of standardizing the mechanical removal of the tongue coating.<br>|
| Experimental: Antimicrobial Photodynamic Therapy Group<br>Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue. | Procedure: Teeth Brushing<br>* All 52 participants will be instructed to brush with toothpaste containing amine fluoride in its composition (Elmex®), 3 times a day after meals for 10 days.<br>Procedure: Dental Flossing<br>* All 52 participants will be instructed to floss, 3 times a day after meals for 10 days.<br>Radiation: Antimicrobial Photodynamic Therapy (aPDT)<br>* One session of aPDT will be conducted, with the photosensitizer (PS) annatto manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient amount to cover the middle third and dorsum of the tongue (5 sprays), for 2 minutes for incubation. Six points will be irradiated, with a distance of 1 cm between the points, considering the scattering halo of the light and effectiveness of aPDT. The device will be previously calibrated with a wavelength of 395-480 nm, for 20 seconds per point, energy of 9.6 J, and the light was radiated so that a halo of 2 cm in diameter per point is formed.<br>|
| Experimental: Probiotics Group<br>Participants in this group will receive treatment with tooth brushing, dental flossing and probiotics. | Procedure: Teeth Brushing<br>* All 52 participants will be instructed to brush with toothpaste containing amine fluoride in its composition (Elmex®), 3 times a day after meals for 10 days.<br>Procedure: Dental Flossing<br>* All 52 participants will be instructed to floss, 3 times a day after meals for 10 days.<br>Dietary Supplement: Probiotics<br>* Pharmaceutical forms will be used (manipulated capsules or chewable gums) containing Lactobacillus salivarius WB21 strains (6.7 x 108 CFU) and xylitol (280mg). They will be delivered to each patient, who must ingest them, 3 times a day after the meals for 7 days.<br>|
| Experimental: Antimicrobial Photodynamic Therapy and Probiotics Group<br>Participants in this group will receive treatment with tooth brushing, dental flossing, antimicrobial photodynamic therapy in the tongue and probiotics. | Procedure: Teeth Brushing<br>* All 52 participants will be instructed to brush with toothpaste containing amine fluoride in its composition (Elmex®), 3 times a day after meals for 10 days.<br>Procedure: Dental Flossing<br>* All 52 participants will be instructed to floss, 3 times a day after meals for 10 days.<br>Radiation: Antimicrobial Photodynamic Therapy (aPDT)<br>* One session of aPDT will be conducted, with the photosensitizer (PS) annatto manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient amount to cover the middle third and dorsum of the tongue (5 sprays), for 2 minutes for incubation. Six points will be irradiated, with a distance of 1 cm between the points, considering the scattering halo of the light and effectiveness of aPDT. The device will be previously calibrated with a wavelength of 395-480 nm, for 20 seconds per point, energy of 9.6 J, and the light was radiated so that a halo of 2 cm in diameter per point is formed.<br>Dietary Supplement: Probiotics<br>* Pharmaceutical forms will be used (manipulated capsules or chewable gums) containing Lactobacillus salivarius WB21 strains (6.7 x 108 CFU) and xylitol (280mg). They will be delivered to each patient, who must ingest them, 3 times a day after the meals for 7 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Halimetry Results | The collection of mouth air will follow the manufacturer's guidelines, the Breath Alert will be disinfected after each use. The appliance should be shaken four or five times before each use to eliminate any residual odors. A ''beep'' is emitted when opening the upper compartment of the o device, and a second beep is emitted when the volunteer blows into the air inlet front (airflow passage). After a third beep, the breath odor is measured and scored on a scale of 0 to 5 points, from best to worst odor. | Baseline, immediately after treatment and after 7 days. | 
| Changes in Microbiological Analysis | Tongue coating samples will be collected with a cotton swab, soaked in Amies charcoal reduced as a medium. The samples will be taken to the laboratory for analysis in a period of less than two hours after collection. The samples will be vortexed for approx. one minute. After homogenization, ten serial dilutions will be prepared in 180 μl of sterile phosphate-buffered saline. Rates of 10-1, 10-2, 10-3, 10-4 and 10-5 will be transferred to sheep blood agar Petri dishes. As the main bacteria responsible for the production of gases are anaerobes, Petri dishes will be incubated in anaerobic conditions for 72 h at 37°C, followed by bacterial counts by colony forming units. | Baseline, immediately after treatment and after 7 days. |