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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Halitosis [Срок оценки: From enrollment to the end of treatment at 6 months]

Вторичные конечные точки (2)

• Probing depth [Срок оценки: From enrollment to the end of treatment at 6 months]
• Clinical Attachment level [Срок оценки: From enrollment to the end of treatment at 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Bauru School of Dentistry — Bauru

Публикации

• 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

Идентификаторы

NCT: NCT07463859 · 7.885.095

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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