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Recruiting NCT07463859

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

No phase Interventional Type 2 Diabetes Halitosis Periodontitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Scaling and root planing, Photodynamic Therapy with Conventional Methylene Blue.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Halitosis, Periodontitis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Procedure Scaling and root planing
    Mechanical removal of biofilm in periodontal pockets and tongue
  • Procedure Photodynamic Therapy with Conventional Methylene Blue
    Antimicrobial photodynamic therapy in periodontal pockets and tongue

Primary outcome measures

  • Halitosis [Time frame: From enrollment to the end of treatment at 6 months]
Secondary outcome measures (2)
  • Probing depth [Time frame: From enrollment to the end of treatment at 6 months]
  • Clinical Attachment level [Time frame: From enrollment to the end of treatment at 6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • Bauru School of Dentistry — Bauru

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. PMID 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/s10103-021-0 PMID 33987732

Identifiers

NCT: NCT07463859 · 7.885.095

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗