CClinicalTrials.gg
Sign In
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

Who can participate

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

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
04

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

05

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

06

Study locations

1 of 1 sites recruiting
  • Bauru School of Dentistry
    Bauru, São Paulo 17012901, Brazil
    Recruiting
07

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

08

Registry details

Key details

Study ID
NCT07463859
Lead sponsor
University of Sao Paulo
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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus, Type 2→

Other studies from this sponsor

University of Sao Paulo

Start the discussion