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

NCT05590897 | Completed Phase 1

• 1 other identifier: MouthBreathing
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Halitosis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Antimicrobial Photodynamic Therapy Group

EXPERIMENTAL

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

Procedure: Teeth Brushing; Procedure: Dental Flossing; Radiation: Antimicrobial Photodynamic Therapy (aPDT)

Tongue Scraping Group

EXPERIMENTAL

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

Procedure: Teeth Brushing; Procedure: Dental Flossing; Procedure: Tongue Scraping

Interventions

Teeth Brushing PROCEDURE

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.

Antimicrobial Photodynamic Therapy Group; Tongue Scraping Group

Dental Flossing PROCEDURE

All 52 participants were instructed to floss, 3 times a day after meals for 30 days.

Antimicrobial Photodynamic Therapy Group; Tongue Scraping Group

Tongue Scraping PROCEDURE

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.

Tongue Scraping Group

Antimicrobial Photodynamic Therapy (aPDT) RADIATION

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.

Antimicrobial Photodynamic Therapy Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (1)

Universidade Metropolitana de Santos - UNIMES

Santos, São Paulo, 11045-002, Brazil

Location

Related Publications (1)

• Bruno LH, Sobral APT, Goncalves MLL, Fossati AL, Santos EM, Gallo JMAS, Ferri EP, Motta PB, Prates RA, Deana AM, Horliana ACRT, Motta LJ, Bussadori SK. 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. Medicine (Baltimore). 2023 Apr 14;102(15):e33512. doi: 10.1097/MD.0000000000033512.

  PMID: 37058047 DERIVED

MeSH Terms

Conditions

Halitosis

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Breath Alert, as the device that will be used to determine the presence of halitosis, is blinded to groups/participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2022
• First Posted: October 21, 2022
• Study Start: February 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 20, 2023
• Last Updated: April 1, 2024

Record last verified: 2024-03

Locations

BR (1)