Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Sao Paulo
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Halitosis
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Masking Description
Simulation of laser treatment
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
- •Alcohol-dependent individuals
- •Pregnant or lactating women
- •Patients with renal disorders
- •Patients using medications that affect the periodontium
Arms & Interventions
aPDT - antimicrobial photodynamic therapy
Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue.
Intervention: Photodynamic Therapy with Conventional Methylene Blue (Procedure)
Control
Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper
Intervention: Scaling and root planing (Procedure)
Outcomes
Primary Outcomes
Halitosis
Time Frame: From enrollment to the end of treatment at 6 months
Measurement of oral volatile compounds by gas chromatography
Secondary Outcomes
- Probing depth(From enrollment to the end of treatment at 6 months)
- Clinical Attachment level(From enrollment to the end of treatment at 6 months)
Investigators
Carla Andreotti Damante
Clinical Professor - Principal investigator
University of Sao Paulo