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

U

University of Nove de Julho

Status and phase

Completed
Phase 2
Phase 1

Conditions

Halitosis

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05590897
MouthBreathing

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

6 to 12 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

Antimicrobial Photodynamic Therapy Group
Experimental group
Description:
Participants in this group will receive treatment with tooth brushing, dental flossing and antimicrobial photodynamic therapy in the tongue.
Treatment:
Procedure: Dental Flossing
Procedure: Teeth Brushing
Radiation: Antimicrobial Photodynamic Therapy (aPDT)
Tongue Scraping Group
Experimental group
Description:
Participants in this group will receive treatment with tooth brushing, dental flossing and tongue scraping.
Treatment:
Procedure: Dental Flossing
Procedure: Teeth Brushing
Procedure: Tongue Scraping

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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