Adding laser-based antimicrobial therapy to deep cleaning and tongue scraping for bad breath in people with type 2 diabetes and severe gum disease
Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial
This trial tests whether adding antimicrobial photodynamic therapy to standard deep cleaning and tongue scraping reduces bad breath in people with type 2 diabetes and advanced periodontitis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (Bauru, São Paulo) |
| Trial ID | NCT07463859 on ClinicalTrials.gov |
What this trial studies
Participants receive conventional periodontal treatment (scaling and root planing) plus tongue scraping, and some participants also receive antimicrobial photodynamic therapy (aPDT) using methylene blue and a light source. Treatments are given weekly for one month, followed by monthly maintenance visits up to six months. Researchers will compare breath odor measurements and periodontal health outcomes between the groups to see if aPDT provides additional benefit. The trial is conducted at the Bauru School of Dentistry, University of Sao Paulo.
Who should consider this trial
Good fit: Ideal candidates are adults with type 2 diabetes (per WHO 2019 criteria), stage 3 or 4 periodontitis, at least 20 remaining teeth, no periodontal treatment in the prior 12 months, and who meet the study's non-smoking and health criteria.
Not a fit: People who smoke, are alcohol-dependent, are pregnant or lactating, have renal disease, use medications that affect the periodontium, or who do not have advanced periodontitis or have fewer than 20 teeth are not good candidates and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding aPDT could further reduce bad breath and improve gum health for people with diabetes and severe periodontitis.
How similar studies have performed: Previous small trials of aPDT as an adjunct to conventional periodontal therapy have shown promising but mixed results, so the approach has some supportive evidence but is not yet definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bauru, São Paulo
- Bauru School of Dentistry — Bauru, São Paulo, Brazil (Recruiting)
Study contacts
- Study coordinator: Carla A. Damante, PhD
- Email: cdamante@usp.br
- Phone: +551432266064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.