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

Phase 1

Completed

• Conditions: Halitosis
• Interventions: Other: Teeth brushing and flossing; Radiation: Antimicrobial Photodynamic Therapy (aPDT); Other: Tongue scraping; Biological: Probiotics

• Registration Number: NCT03996044
• Lead Sponsor: University of Nove de Julho

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-21
• Study First Submitted QC: 2019-06-21
• Study First Posted: 2019-06-24
• Study Start: 2021-01-20
• Primary Completion: 2021-06-30
• Study Completion: 2021-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-15
• Last Update Posted: 2023-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 2	Antimicrobial Photodynamic Therapy (aPDT)	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.
Group 1	Tongue scraping	Thirteen patients who will receive treatment with teeth brushing, dental floss and tongue scraper.
Group 3	Teeth brushing and flossing	Thirteen patients who will receive treatment with teeth brushing, dental floss and probiotics.
Group 3	Probiotics	Thirteen patients who will receive treatment with teeth brushing, dental floss and probiotics.
Group 1	Teeth brushing and flossing	Thirteen patients who will receive treatment with teeth brushing, dental floss and tongue scraper.
Group 2	Teeth brushing and flossing	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.
Group 4	Teeth brushing and flossing	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..
Group 4	Probiotics	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..
Group 4	Antimicrobial Photodynamic Therapy (aPDT)	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..

Primary Outcome Measures

Name	Time	Method
Change in halimetry (gas chromatography)	Baseline, immediately after treatment, 7 days and 30 days after treatment.	Oral air collection will follow the manufacturer's guidelines (Oral ChromaTM Manual Instruction) where the participant will be instructed to rinse with cysteine (10 mM) for 1 minute, then remain with his/her mouth closed for 1 minute. A syringe from the same manufacturer for collection of mouth air will be introduced into the patient's mouth. During 1 minute the patient will remain closed mouth, breathing through the nose, without touching the syringe with the tongue. The plunger will be pulled out, we will re-empty the syringe air into the patient's mouth and again pull the plunger to fill the syringe with the breath sample. We will wipe the tip of the syringe with gauze to remove moisture from the saliva, place the gas injection needle in the syringe, and adjust the plunger to 0.5 ml. The gases collected at the entrance door of the appliance are injected in a single movement.

Secondary Outcome Measures

Name	Time	Method
Change in microbiological analysis of tongue coating	Baseline, immediately after treatment, 7 days and 30 days after treatment.	Samples of the tongue coating will be collected using a sterile swab that will be passed on the surface of the back of the tongue with a back and forth movement (10 times). Samples will be deposited in sterile tubes that will be identified and stored at -80°C until analyzed. After thawing, the samples will be vortexed for one minute. For extraction of bacterial DNA, samples will be boiled for 10 minutes and then centrifuged at 10,000 rpm for 10 minutes. The supernatant will be placed in a new microtube containing 100μL of phenol/chloroform/isoamyl alcohol (25: 24: 1), followed by ethanol precipitation. The purified DNA will be resuspended in TE buffer. The levels of P. gingivalis, T. forsythia and T. denticola, will be analyzed by quantitative PCR. The quantitative analysis will be performed using real-time PCR using Step One Plus Thermal-Time PCR System and fluorescence-detected products using the Quantimix Easy SYG Kit, following the protocol recommended by the manufacturer.

Trial Locations

Locations (1)

Universidade Nove de Julho; 🇧🇷 São Paulo, SP, Brazil