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

Primary Purpose

Halitosis

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Teeth Brushing
Dental Flossing
Tongue Scraping
Antimicrobial Photodynamic Therapy (aPDT)
Probiotics
Sponsored by
University of Nove de Julho
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Halitosis

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Tongue Scraping Group

    Antimicrobial Photodynamic Therapy Group

    Probiotics Group

    Antimicrobial Photodynamic Therapy and Probiotics Group

    Arm Description

    Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping.

    Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue.

    Participants in this group will receive treatment with tooth brushing, dental flossing and probiotics.

    Participants in this group will receive treatment with tooth brushing, dental flossing, antimicrobial photodynamic therapy in the tongue and probiotics.

    Outcomes

    Primary Outcome Measures

    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 19, 2022
    Last Updated
    October 19, 2022
    Sponsor
    University of Nove de Julho
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05590897
    Brief Title
    Comparative Study Between Photodynamic Therapy and the Use of Probiotics in the Reduction of Halitosis in Mouth Breathing Children
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    December 20, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Nove de Julho

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Halitosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Th Breath Alert, as the device that will be used to determine the presence of halitosis, is blinded to groups/participants. Microbiological analysis will also be conducted by a blinded assessor, who will not know to which participant/group the samples belong to.
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tongue Scraping Group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping.
    Arm Title
    Antimicrobial Photodynamic Therapy Group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue.
    Arm Title
    Probiotics Group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive treatment with tooth brushing, dental flossing and probiotics.
    Arm Title
    Antimicrobial Photodynamic Therapy and Probiotics Group
    Arm Type
    Experimental
    Arm Description
    Participants in this group will receive treatment with tooth brushing, dental flossing, antimicrobial photodynamic therapy in the tongue and probiotics.
    Intervention Type
    Procedure
    Intervention Name(s)
    Teeth Brushing
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Dental Flossing
    Intervention Description
    All 52 participants will be instructed to floss, 3 times a day after meals for 10 days.
    Intervention Type
    Procedure
    Intervention Name(s)
    Tongue Scraping
    Intervention Description
    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.
    Intervention Type
    Radiation
    Intervention Name(s)
    Antimicrobial Photodynamic Therapy (aPDT)
    Intervention Description
    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.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Probiotics
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Changes in Halimetry Results
    Description
    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.
    Time Frame
    Baseline, immediately after treatment and after 7 days.
    Title
    Changes in Microbiological Analysis
    Description
    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.
    Time Frame
    Baseline, immediately after treatment and after 7 days.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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