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NCT Number: NCT07463859

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Halitosis Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Periodontal Diseases Periodontitis Signs and Symptoms Signs and Symptoms, Digestive Stomatognathic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012901, Brazil

Location status: Recruiting

Location contact

Carla A. Damante, PhD

CONTACT

[email protected]

+55 1432266064

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Scaling and Root Planing

Procedure

Mechanical removal of biofilm in periodontal pockets and tongue

Photodynamic Therapy with Conventional Methylene Blue

Procedure

Antimicrobial photodynamic therapy in periodontal pockets and tongue

Primary outcomes

  1. Halitosis

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

    Measurement of oral volatile compounds by gas chromatography

Secondary outcomes

  1. Probing depth

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

    Measurement in milimeters of the periodontal pocket

  2. Clinical Attachment level

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

    Measuremet in milimeters from cementoenamel junction to bottom of the pocket

Study contacts

Contact information is provided by the study sponsor or research team.

Carla A. Damante, PhD

CONTACT

[email protected]

+551432266064

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 11, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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