Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction

University of Nove de Julho

Status and phase: Completed; Phase 1

Conditions: Halitosis

Treatments: Other: Tongue scraping; Other: Teeth brushing and flossing; Biological: Probiotics; Radiation: Antimicrobial Photodynamic Therapy (aPDT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03996044

Pamella

Details and patient eligibility

About

Introduction: Halitosis is a term that defines any foul odor emanating from the oral cavity. The origin may be local or systemic. The aim of the proposed project is to determine whether treatment with antimicrobial photodynamic therapy (aPDT) and treatment with probiotics are effective at eliminating halitosis. Methods and analysis: Fifty-two patients from 18 to 25 years old with a diagnosis of halitosis (H2S≥112 ppb determined by gas chromatography) will be randomly allocated to four groups (n=13) who will receive different treatments: Group 1 - treatment with teeth brushing, dental floss and tongue scraper; Group 2 - brushing, dental floss and aPDT; Group 3 - brushing, dental floss and probiotics; Group 4 - brushing, flossing, aPDT and probiotics. The results of the halimeter testing will be compared before, immediately after, seven days and thirty days after treatment. The microbiological analysis of the coated tongue will be performed at these same times. The quantitative analysis will be conducted using real-time PCRq. The normality of the data will be determined using the Shapiro-Wilk test. Data with normal distribution will be analyzed using analysis of variance (ANOVA). Non-parametric data will be analyzed using the Kruskal-Wallis test. The Wilcoxon test will be used to analyze the results of each treatment at the different evaluation periods. Ethics and dissemination: This study has been approved by the Ethics Committee of UNINOVE under process number 3.669.442. Results will be published in peer-reviewed journals and will be presented at national and international conferences.

Enrollment: 52 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age between 18 and 25 years;
• Sulphide (SH2) ≥ 112 ppb in the gas chromatography.

Exclusion criteria

• Dentofacial anomalies (such as cleft lip and cleft palate);
• Undergoing orthodontic and/or orthopedic treatment;
• Undergoing oncological treatment;
• Systemic alterations (gastrointestinal, renal, hepatic);
• Treatment with antibiotics up to 1 month before the survey;
• Pregnant.
• Individuals with fissured tongue

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 4 patient groups

Group 1

Experimental group

Description:

Thirteen patients who will receive treatment with teeth brushing, dental floss and tongue scraper.

Treatment:

Other: Tongue scraping

Other: Teeth brushing and flossing

Group 2

Experimental group

Description:

Thirteen patients who will receive treatment with teeth brushing, dental floss and antimicrobial photodynamic therapy applied to the back and middle third of the tongue.

Treatment:

Radiation: Antimicrobial Photodynamic Therapy (aPDT)

Other: Teeth brushing and flossing

Group 3

Experimental group

Description:

Thirteen patients who will receive treatment with teeth brushing, dental floss and probiotics.

Treatment:

Biological: Probiotics

Other: Teeth brushing and flossing

Group 4

Experimental group

Description:

Thirteen patients who will receive treatment with teeth brushing, dental floss, antimicrobial photodynamic therapy applied to the back and middle third of the tongue and probiotics..

Treatment:

Biological: Probiotics

Radiation: Antimicrobial Photodynamic Therapy (aPDT)

Other: Teeth brushing and flossing