MedDataX Logo

Adjunctive Effect of Photodynamic Therapy on Halitosis

NCT ID: NCT06764342

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-08

Study Completion Date

2025-06-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Periodontitis Halitosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

halitosis periodontitis full-mouth disinfection antimicrobial photodynamic therapy real time polymerase chain reaction bacteria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Full-mouth scaling

Full-mouth ultrasonic and manual periodontal instrumentation

Group Type ACTIVE_COMPARATOR

full-mouth scaling

Intervention Type PROCEDURE

Full-mouth scaling within 24 hours, divided into two sessions of ultrasonic instrumentation followed by manual supra- and subgingival scaling and root planing. Tongue cleaning was performed with a tongue scraper.

Full-mouth scaling combined with antimicrobial photodynamic therapy

Full-mouth ultrasonic and manual periodontal instrumentation combined with antimicrobial photodynamic therapy applied to tongue dorsum and periodontal pockets

Group Type EXPERIMENTAL

Full-mouth scaling combined with antimicrobial photodynamic therapy

Intervention Type RADIATION

After full-mouth scaling procedures antimicrobial photodynamic therapy was carried out using a laser-activated disinfection device with a red laser emission (wavelength: 630 nm, irradiance: 2000-4000 mW/cm², spot size at the probe tip: 8 mm diameter) and high-viscosity methylene blue gel (0.1 mg/mL) which was applied at six spots on the tongue dorsum. Antimicrobial photodynamic therapy was also applied iIn sites with altered periodontal pocket depth (≥ 4mm). The dye remained in the pockets for 10 minutes to ensure full absorption and its excess was rinsed with sterile saline after laser exposure.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Full-mouth scaling combined with antimicrobial photodynamic therapy

After full-mouth scaling procedures antimicrobial photodynamic therapy was carried out using a laser-activated disinfection device with a red laser emission (wavelength: 630 nm, irradiance: 2000-4000 mW/cm², spot size at the probe tip: 8 mm diameter) and high-viscosity methylene blue gel (0.1 mg/mL) which was applied at six spots on the tongue dorsum. Antimicrobial photodynamic therapy was also applied iIn sites with altered periodontal pocket depth (≥ 4mm). The dye remained in the pockets for 10 minutes to ensure full absorption and its excess was rinsed with sterile saline after laser exposure.

Intervention Type RADIATION

full-mouth scaling

Full-mouth scaling within 24 hours, divided into two sessions of ultrasonic instrumentation followed by manual supra- and subgingival scaling and root planing. Tongue cleaning was performed with a tongue scraper.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Fernando O Costa

titular professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fernando O Costa, doctorate

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais, Dental School

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Federal University of Minas Gerais, Dental School

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NTC02368678

Identifier Type: REGISTRY

Identifier Source: secondary_id

30378613.5.0000.5149

Identifier Type: -

Identifier Source: org_study_id