Adjunctive Effect of Photodynamic Therapy on Halitosis

Not Applicable

• Conditions: Periodontitis; Halitosis

• Registration Number: NCT06764342
• Lead Sponsor: Federal University of Minas Gerais

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.

Study Timeline

• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study Start: 2025-01-08
• Study First Posted: 2025-01-08
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-12
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-02-22
• Study Completion: 2025-06-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
sulfur volatile compounds changes	baseline versus 21 and 45 days after treatment	pre and post-treatment changes in levels (parts per billion) of CH3SH, a sulfur volatile compound

Secondary Outcome Measures

Name	Time	Method
Changes in periodontal probing depth	baseline versus 45 days after treatment	Pre and pos-treatment changes in periodontal pocket depth (mm)
Changes in organoleptic testing	Baseline versus 45 days after treatment	Pre and post-treatment changes in organoleptic scores
Changes in tongue total bacteria count	baseline versus 45 days after treatment	Pre- and post-treatment changes in total bacteria counts from tongue dorsal samples

Trial Locations

Locations (1)

Federal University of Minas Gerais, Dental School; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil