PeriodontitisNCT06764342
Adjunctive Effect of Photodynamic Therapy on Halitosis
A study testing Full-mouth scaling combined with antimicrobial photodynamic therapy and full-mouth scaling in people with Periodontitis and Halitosis, run by Federal University of Minas Gerais at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Periodontitis, Halitosis
- What is being tested?
- Full-mouth scaling combined with antimicrobial photodynamic therapy and full-mouth scaling
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jan 2025to 25 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- self-reported halitosis;
- organoleptic score >2;
- stage III periodontitis;
- at least 14 teeth.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Minas Gerais, Dental School
Belo Horizonte, Minas Gerais, 31270-901
About this study
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.
Read the 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.
- Conditions
- Periodontitis, Halitosis
- Being tested
- Full-mouth scaling combined with antimicrobial photodynamic therapy, full-mouth scaling
- Keywords
- halitosis, periodontitis, full-mouth disinfection, antimicrobial photodynamic therapy, real time polymerase chain reaction, bacteria
- Medical subject headings
- Periodontitis, Halitosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-mouth scaling combined with antimicrobial photodynamic therapyRadiation
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.
full-mouth scalingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Full-mouth scaling | Active comparator | Full-mouth ultrasonic and manual periodontal instrumentation Receives: Procedure: full-mouth scaling |
| Full-mouth scaling combined with antimicrobial photodynamic therapy | Experimental | Full-mouth ultrasonic and manual periodontal instrumentation combined with antimicrobial photodynamic therapy applied to tongue dorsum and periodontal pockets Receives: Radiation: Full-mouth scaling combined with antimicrobial photodynamic therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
sulfur volatile compounds changes
pre and post-treatment changes in levels (parts per billion) of CH3SH, a sulfur volatile compound
Measured: baseline versus 21 and 45 days after treatment
Secondary outcomes (3)
Changes in periodontal probing depth
Pre and pos-treatment changes in periodontal pocket depth (mm)
Measured: baseline versus 45 days after treatment
Changes in organoleptic testing
Pre and post-treatment changes in organoleptic scores
Measured: Baseline versus 45 days after treatment
Changes in tongue total bacteria count
Pre- and post-treatment changes in total bacteria counts from tongue dorsal samples
Measured: baseline versus 45 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start8 Jan 2025
- Primary completion22 Feb 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Minas Gerais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando O Costa, Federal University of Minas Gerais
- Investigators
- Fernando O Costa, doctorate, Principal investigator, Federal University of Minas Gerais, Dental School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764342
- Sponsor's protocol ID
- 30378613.5.0000.5149
- Other IDs
- NTC02368678
- Status last verified
- Dec 2025
- First submitted
- 2 Jan 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be analyzed by group and using numerical codes avoiding individual personal data identification. Data access will be protected by password.
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Effect of Photodynamic Therapy on Halitosis
- ClinicalTrials.gov ID
- NCT06764342
- Acronym / sponsor ID
- 30378613.5.0000.5149
- Conditions
- Periodontitis, Halitosis
- Keywords
- halitosis, periodontitis, full-mouth disinfection, antimicrobial photodynamic therapy, real time polymerase chain reaction, bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Federal University of Minas GeraisUniversity, hospital or other
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 22 Feb 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 8 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-mouth scaling | Active comparator | Procedure: full-mouth scalingFull-mouth ultrasonic and manual periodontal instrumentation |
| Full-mouth scaling combined with antimicrobial photodynamic therapy | Experimental | Radiation: Full-mouth scaling combined with antimicrobial photodynamic therapyFull-mouth ultrasonic and manual periodontal instrumentation combined with antimicrobial photodynamic therapy applied to tongue dorsum and periodontal pockets |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- self-reported halitosis;
- organoleptic score >2;
- stage III periodontitis;
- at least 14 teeth.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-mouth scaling combined with antimicrobial photodynamic therapyAfter 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. | Radiation | Full-mouth scaling combined with antimicrobial photodynamic therapy |
| full-mouth scalingFull-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. | Procedure or surgery | Full-mouth scaling |
Primary outcome
sulfur volatile compounds changes
Time frame: baseline versus 21 and 45 days after treatment
pre and post-treatment changes in levels (parts per billion) of CH3SH, a sulfur volatile compound
3 secondary outcomes
Changes in periodontal probing depth
Time frame: baseline versus 45 days after treatment
Changes in organoleptic testing
Time frame: Baseline versus 45 days after treatment
Changes in tongue total bacteria count
Time frame: baseline versus 45 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: No. Data will be analyzed by group and using numerical codes avoiding individual personal data identification. Data access will be protected by password.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando O Costa, doctorate principal investigator
Federal University of Minas Gerais, Dental School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-mouth scaling combined with antimicrobial photodynamic therapy and full-mouth scaling in people with Periodontitis and Halitosis, run by Federal University of Minas Gerais at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sulfur volatile compounds changes (time frame: baseline versus 21 and 45 days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.