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

NCT ID: NCT03996044

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2021-11-30

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.

Conditions

Halitosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

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

Group Type: EXPERIMENTAL

Teeth brushing and flossing

Intervention Type: OTHER

All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.

Tongue scraping

Intervention Type: OTHER

Tongue scraping will be performed by the same operator on all participants. Posterior-anterior movements will be performed with the scraper over the tongue dorsum, followed by cleaning the scraper with a gauze. This procedure will be performed ten times in each patient, in order to standardize the mechanical removal of the tongue coating.

Group 2

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 Type: EXPERIMENTAL

Teeth brushing and flossing

Intervention Type: OTHER

All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.

Antimicrobial Photodynamic Therapy (aPDT)

Intervention Type: RADIATION

One session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. The excess will be removed with a sucker in order to keep the surface wet with the PS itself, without using water. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.

Group 3

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

Group Type: EXPERIMENTAL

Teeth brushing and flossing

Intervention Type: OTHER

All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.

Probiotics

Intervention Type: BIOLOGICAL

Pharmacy-manipulated capsules containing strains of Lactobacillus salivarius WB21 (6.7 x 108 CFU) and xylitol (280mg) will be used. Forty-two capsules will be delivered for each patient, who should take 1 capsule 3 times a day after meals for 14 days.

Group 4

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 Type: EXPERIMENTAL

Teeth brushing and flossing

Intervention Type: OTHER

All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.

Antimicrobial Photodynamic Therapy (aPDT)

Intervention Type: RADIATION

One session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. The excess will be removed with a sucker in order to keep the surface wet with the PS itself, without using water. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.

Probiotics

Intervention Type: BIOLOGICAL

Pharmacy-manipulated capsules containing strains of Lactobacillus salivarius WB21 (6.7 x 108 CFU) and xylitol (280mg) will be used. Forty-two capsules will be delivered for each patient, who should take 1 capsule 3 times a day after meals for 14 days.

Interventions

Teeth brushing and flossing

All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.

Intervention Type: OTHER

Tongue scraping

Tongue scraping will be performed by the same operator on all participants. Posterior-anterior movements will be performed with the scraper over the tongue dorsum, followed by cleaning the scraper with a gauze. This procedure will be performed ten times in each patient, in order to standardize the mechanical removal of the tongue coating.

Intervention Type: OTHER

Antimicrobial Photodynamic Therapy (aPDT)

One session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. The excess will be removed with a sucker in order to keep the surface wet with the PS itself, without using water. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.

Intervention Type: RADIATION

Probiotics

Pharmacy-manipulated capsules containing strains of Lactobacillus salivarius WB21 (6.7 x 108 CFU) and xylitol (280mg) will be used. Forty-two capsules will be delivered for each patient, who should take 1 capsule 3 times a day after meals for 14 days.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Sandra Kalil Bussadori

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidade Nove de Julho

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Motta PB, Goncalves MLL, Gallo JMAS, Sobral APT, Motta LJ, Mayer MPA, Kawamoto D, de Andrade DC, Santos EM, Fernandes KPS, Mesquita-Ferrari RA, Deana AM, Horliana ACRT, Kalil Bussadori S. Short term effect of antimicrobial photodynamic therapy and probiotic L. salivarius WB21 on halitosis: A controlled and randomized clinical trial. PLoS One. 2024 Jul 2;19(7):e0297351. doi: 10.1371/journal.pone.0297351. eCollection 2024.

Reference Type: DERIVED

PMID: 38954692 (View on PubMed)

Motta PB, Motta LJ, Costa da Mota AC, Leal Goncalves ML, Silva T, Momolli M, de Andrade DC, Santos Fernandes KP, Mesquita-Ferrari RA, Deana AM, Wainwright M, Prates RA, Horliana ACRT, Bussadori SK. Comparative study between photodynamic therapy with urucum + Led and probiotics in halitosis reduction-protocol for a controlled clinical trial. PLoS One. 2021 May 14;16(5):e0247096. doi: 10.1371/journal.pone.0247096. eCollection 2021.

Reference Type: DERIVED

PMID: 33989296 (View on PubMed)

Other Identifiers

Pamella

Identifier Type: -

Identifier Source: org_study_id