Clinical trial NCT06764342: Adjunctive Effect of Photodynamic Therapy on Halitosis
Official title: Adjunctive Effect of Photodynamic Therapy on Halitosis
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Periodontitis
Halitosis
Keywords: halitosis
periodontitis
full-mouth disinfection
antimicrobial photodynamic therapy
real time polymerase chain reaction
bacteria
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study aims to evaluate bad breath in patients undergoing gingival treatment combined with tongue scraping and laser and to assess its potential benefits for both periodontal and microbiological condition. Firs patients will be selected among those who participated in a privies study. Additional patients will be also invited. They must have gum disease and bad breath. Treatments will be completed within 24 hours and oral samples will be collected with thin paper points. Bad breath will be evaluated by a professional and a specific gas machine.

Detailed description: The present study aims to evaluate halitosis in patients undergoing non-surgical periodontal therapy \[(Full-mouth disinfection (FMD) combined with tongue scraping and antimicrobial photodynamic therapy (aPDT), and to assess its potential benefits for both periodontal and microbiological condition. A pilot study will be performed with participants who took part almost 10 years ago in the study NCT02368678. They will be invited by phone contact. In addition, new participants will be recruited by convenience in dental clinics from the Federal University of Minas Gerais until completion of 20 participants per group. Individuals with stage III periodontitis and halitosis (organoleptic method \> 2), will be allocated into two periodontal treatment groups. Halitosis will be assessed using the organoleptic method and gas chromatography (OralChroma device) at three time points: before and after treatments. Microbiological samples will be collected before and after treatments from periodontal pockets and pooled samples from the tongue dorsum. These samples will be analyzed by using real-time PCR (q-PCR) aiming at detecting target bacterial species.

Eligibility criteria: Inclusion Criteria:

* self-reported halitosis;
* organoleptic score \>2;
* stage III periodontitis;
* at least 14 teeth.

Exclusion Criteria:

* smokers or former smokers;
* individuals diagnosed with diabetes and/or immune diseases;
* pregnant or lactating women;
* individuals with removable partial dentures and/or fixed or removable orthodontic appliances;
* systemic use of antibiotics or anti-inflammatory drugs in the last three months; - individuals who required prophylactic antibiotics for periodontal exams and treatments;
* individuals who regularly used or had used any type of mouthwash in the past three months;
* individuals who underwent periodontal treatment in the six months prior to the study.

Primary outcomes:
measure: sulfur volatile compounds changes
timeFrame: baseline versus 21 and 45 days after treatment
Secondary outcomes:
measure: Changes in periodontal probing depth
timeFrame: baseline versus 45 days after treatment
measure: Changes in organoleptic testing
timeFrame: Baseline versus 45 days after treatment
measure: Changes in tongue total bacteria count
timeFrame: baseline versus 45 days after treatment
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais, Dental School
state: Minas Gerais
Study officials:
affiliation: Federal University of Minas Gerais, Dental School
name: Fernando O Costa, doctorate
role: PRINCIPAL_INVESTIGATOR
References: