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

NCT ID: NCT05590897

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-12-20

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Antimicrobial Photodynamic Therapy Group

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

Group Type: EXPERIMENTAL

Teeth Brushing

Intervention Type: 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.

Dental Flossing

Intervention Type: PROCEDURE

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

Antimicrobial Photodynamic Therapy (aPDT)

Intervention Type: 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.

Tongue Scraping Group

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

Group Type: EXPERIMENTAL

Teeth Brushing

Intervention Type: 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.

Dental Flossing

Intervention Type: PROCEDURE

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

Tongue Scraping

Intervention Type: 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.

Interventions

Teeth Brushing

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.

Intervention Type: PROCEDURE

Dental Flossing

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

Intervention Type: PROCEDURE

Tongue Scraping

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.

Intervention Type: PROCEDURE

Antimicrobial Photodynamic Therapy (aPDT)

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Metropolitana de Santos - UNIMES

Santos, São Paulo, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 37058047 (View on PubMed)

Other Identifiers

MouthBreathing

Identifier Type: -

Identifier Source: org_study_id