Clinical trial NCT03996044: Comparative Study Between Photodynamic Therapy With Urucum and LED and Probiotics in Halitosis Reduction
Official title: Comparative Study Between Photodynamic Therapy Using Urucum + LED and Probiotics in Halitosis Reduction - Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Halitosis
Lead sponsor: University of Nove de Julho
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in halimetry (gas chromatography)
timeFrame: Baseline, immediately after treatment, 7 days and 30 days after treatment.
Secondary outcomes:
measure: Change in microbiological analysis of tongue coating
timeFrame: Baseline, immediately after treatment, 7 days and 30 days after treatment.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Universidade Nove de Julho
state: SP
Study officials:
References:
citation: 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.