Type 2 DiabetesNCT07463859
Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus
A study testing Scaling and root planing and Photodynamic Therapy with Conventional Methylene Blue in people with Type 2 Diabetes and Halitosis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes, Halitosis, Periodontitis
- What is being tested?
- Scaling and root planing and Photodynamic Therapy with Conventional Methylene Blue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Apr 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with type 2 diabetes mellitus according to the 2019 WHO criteria
- Stage 3 or 4 periodontitis
- No periodontal treatment in the previous 12 months
- a minimum of 20 remaining teeth.
Who cannot join
- Smokers
- Alcohol-dependent individuals
- Pregnant or lactating women
- Patients with renal disorders
- Patients using medications that affect the periodontium
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Bauru School of Dentistry
Bauru, São Paulo, 17012901
Carla A. Damante, PhD, +55 1432266064, cdamante@usp.br
About this study
Official title: Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. The main question it aims to answer is: aPDT treatment is more effective in treating halitosis? aPDT treatment is more effective in periodontitis? Researchers will compare aPDT treatment to conventional treatment (scaling and root planning and tongue scraper) to see if aPDT has additional effects in reducing halitosis and improving periodontal health.
- Participants will be asked to visit the clinic once a week for exam and treatment during 1 month.
- After active treatment they will be asked to come to maintenance and control visits once a month until 6 months.
- Conditions
- Type 2 Diabetes, Halitosis, Periodontitis
- Being tested
- Scaling and root planing, Photodynamic Therapy with Conventional Methylene Blue
- Keywords
- Halitosis, periodontitis, lasers, Photodynamic Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2, Halitosis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and root planingProcedure or surgery
Mechanical removal of biofilm in periodontal pockets and tongue
Photodynamic Therapy with Conventional Methylene BlueProcedure or surgery
Antimicrobial photodynamic therapy in periodontal pockets and tongue
| Study group | Role | What they receive |
|---|---|---|
| aPDT - antimicrobial photodynamic therapy | Experimental | Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue. Receives: Procedure: Photodynamic Therapy with Conventional Methylene Blue |
| Control | Active comparator | Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper Receives: Procedure: Scaling and root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Halitosis
Measurement of oral volatile compounds by gas chromatography
Measured: From enrollment to the end of treatment at 6 months
Secondary outcomes (2)
Probing depth
Measurement in milimeters of the periodontal pocket
Measured: From enrollment to the end of treatment at 6 months
Clinical Attachment level
Measuremet in milimeters from cementoenamel junction to bottom of the pocket
Measured: From enrollment to the end of treatment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study start2 Apr 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carla Andreotti Damante, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463859
- Sponsor's protocol ID
- 7.885.095
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bruno LH, Mandetta ARH, Sobral APT, Leal Goncalves ML, Santos EM, Fossati AL, Gallo JMAS, Motta PB, Deana AM, Horliana ACRT, Motta LJ, Ferrari RAM, Santos Fernandes KP, Kalil Bussadori S. Assessment of photodynamic therapy with annatto and led for the treatment of halitosis in mouth-breathing children: Randomized controlled clinical trial. PLoS One. 2024 Sep 3;19(9):e0307957. doi: 10.1371/journal.pone.0307957. eCollection 2024.
PubMed 39226284da Mota ACC, Goncalves MLL, Horliana ACRT, Deana AM, de Souza Cavalcante LA, Gomes AO, Mayer MPA, Suguimoto ESA, Fernandes KPS, Mesquita-Ferrari RA, Prates RA, Motta LJ, Bussadori SK. Effect of antimicrobial photodynamic therapy with red led and methylene blue on the reduction of halitosis: controlled microbiological clinical trial. Lasers Med Sci. 2022 Mar;37(2):877-886. doi: 10.1007/s10103-021-03325-x. Epub 2021 May 13.
PubMed 33987732
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07463859
- Acronym / sponsor ID
- 7.885.095
- Conditions
- Type 2 Diabetes, Halitosis, Periodontitis
- Keywords
- Halitosis, periodontitis, lasers, Photodynamic Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Apr 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 Mar 2026 (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 goal of this clinical trial is to evaluate the effectiveness of periodontal treatment associated with the use of a tongue scraper, compared with the same treatment combined with antimicrobial photodynamic therapy (aPDT), in reducing halitosis in individuals with periodontal disease and type 2 diabetes mellitus. The main question it aims to answer is: aPDT treatment is more effective in treating halitosis? aPDT treatment is more effective in periodontitis? Researchers will compare aPDT treatment to conventional treatment (scaling and root planning and tongue scraper) to see if aPDT has additional effects in reducing halitosis and improving periodontal health.
- Participants will be asked to visit the clinic once a week for exam and treatment during 1 month.
- After active treatment they will be asked to come to maintenance and control visits once a month until 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aPDT - antimicrobial photodynamic therapy | Experimental | Procedure: Photodynamic Therapy with Conventional Methylene BlueTreatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue. |
| Control | Active comparator | Procedure: Scaling and root planingTreatment of periodontal pockets with scaling and root planing and tongue with tongue scraper |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with type 2 diabetes mellitus according to the 2019 WHO criteria
- Stage 3 or 4 periodontitis
- No periodontal treatment in the previous 12 months
- a minimum of 20 remaining teeth.
Key exclusion criteria (5 listed)
- Smokers
- Alcohol-dependent individuals
- Pregnant or lactating women
- Patients with renal disorders
- Patients using medications that affect the periodontium
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 |
|---|---|---|
| Scaling and root planingMechanical removal of biofilm in periodontal pockets and tongue | Procedure or surgery | Control |
| Photodynamic Therapy with Conventional Methylene BlueAntimicrobial photodynamic therapy in periodontal pockets and tongue | Procedure or surgery | aPDT - antimicrobial photodynamic therapy |
Primary outcome
Halitosis
Time frame: From enrollment to the end of treatment at 6 months
Measurement of oral volatile compounds by gas chromatography
2 secondary outcomes
Probing depth
Time frame: From enrollment to the end of treatment at 6 months
Clinical Attachment level
Time frame: From enrollment to the end of treatment at 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 39226284Bruno LH, Mandetta ARH, Sobral APT, Leal Goncalves ML, Santos EM, Fossati AL, Gallo JMAS, Motta PB, Deana AM, Horliana ACRT, Motta LJ, Ferrari RAM, Santos Fernandes KP, Kalil Bussadori S. Assessment of photodynamic therapy with annatto and led for the treatment of halitosis in mouth-breathing children: Randomized controlled clinical trial. PLoS One. 2024 Sep 3;19(9):e0307957. doi: 10.1371/journal.pone.0307957. eCollection 2024.
- Background: PubMed 33987732da Mota ACC, Goncalves MLL, Horliana ACRT, Deana AM, de Souza Cavalcante LA, Gomes AO, Mayer MPA, Suguimoto ESA, Fernandes KPS, Mesquita-Ferrari RA, Prates RA, Motta LJ, Bussadori SK. Effect of antimicrobial photodynamic therapy with red led and methylene blue on the reduction of halitosis: controlled microbiological clinical trial. Lasers Med Sci. 2022 Mar;37(2):877-886. doi: 10.1007/s10103-021-03325-x. Epub 2021 May 13.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and root planing and Photodynamic Therapy with Conventional Methylene Blue in people with Type 2 Diabetes and Halitosis, run by University of Sao Paulo 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 5 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carla A. Damante, PhD (+551432266064, cdamante@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Halitosis (time frame: From enrollment to the end of treatment at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07463859, which also lists 2 linked publications.
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 16 Mar 2026.