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RecruitingNCT07463859Updated Mar 16, 2026

Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus

An interventional study of Scaling and root planing and Photodynamic Therapy with Conventional Methylene Blue in Type 2 Diabetes, Halitosis and Periodontitis, sponsored by University of Sao Paulo. Recruiting at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-16.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Type 2 Diabetes
  • Halitosis
  • Periodontitis

Keywords

  • Halitosis
  • periodontitis
  • lasers
  • Photodynamic Therapy
03

In context

Diabetes Mellitus, Type 2

10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.

This study's planned enrollment of 32 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,035 studies on the registry; 95 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Smokers
  • Alcohol-dependent individuals
  • Pregnant or lactating women
  • Patients with renal disorders
  • Patients using medications that affect the periodontium
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    aPDT - antimicrobial photodynamic therapy

    Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue.

    Procedure: Photodynamic Therapy with Conventional Methylene Blue

  • Active comparator
    Control

    Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper

    Procedure: Scaling and root planing

Interventions

  • ProcedureScaling and root planing

    Mechanical removal of biofilm in periodontal pockets and tongue

  • ProcedurePhotodynamic Therapy with Conventional Methylene Blue

    Antimicrobial photodynamic therapy in periodontal pockets and tongue

06

What researchers measure

Primary outcomes

  1. Halitosis

    Measurement of oral volatile compounds by gas chromatography

    Time frame: From enrollment to the end of treatment at 6 months

Secondary outcomes

  1. Probing depth

    Measurement in milimeters of the periodontal pocket

    Time frame: From enrollment to the end of treatment at 6 months

  2. Clinical Attachment level

    Measuremet in milimeters from cementoenamel junction to bottom of the pocket

    Time frame: From enrollment to the end of treatment at 6 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 39226284 ↗
  • da 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Apr 2026; primary completion for Jan 2027, 9 months later.

Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 9 months is below that.

Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 5, 2026
First posted
Mar 11, 2026
StartEst.
Apr 2, 2026
Primary completionEst.
Jan 31, 2027
CompletionEst.
Feb 28, 2027
Last update
Mar 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07463859
Responsible party
Carla Andreotti Damante (Clinical Professor - Principal investigator, University of Sao Paulo) — Principal investigator
First posted
Mar 11, 2026
Start date
Apr 2, 2026 (estimated)
Primary completion
Jan 31, 2027 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Mar 16, 2026

Study contacts

Carla A. Damante, PhD
Contact
cdamante@usp.br
+551432266064

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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