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Antimicrobial photodynamic therapy combined with periodontal treatment for metabolic control in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial.

ABSTRACT: The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic control and increases proteins found in the acute phase of inflammation, such as C-reactive protein. The gold standard for the treatment of periodontal disease is oral hygiene orientation, scaling and planing. Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to minimize the prescription of antibiotics, photodynamic therapy (PDT) has been studied as an antimicrobial technique and has demonstrated promising results. The aim of the proposed study is to determine whether PDT as a complement to periodontal therapy (PT) is helpful in the metabolic control of individuals with type 2 diabetes and the reduction of acute-phase inflammatory markers.The patients will be randomized using a proper software program into two groups: 1) PT + placebo PDT or 2) PT + active PDT. All patients will first be examined by a specialist, followed by PT performed by two other healthcare professionals. At the end of each session, PDT (active or placebo) will be administered by a fourth healthcare professional. The following will be the PDT parameters: diode laser (660 nm); power output = 110 mW; exposure time = 90 s per point (9 J/point); and energy density = 22 J/cm(2). The photosensitizer will be methylene blue (50 ?g/mL). The patients will be re-evaluated 15, 30, 90 and 180 days after treatment. Serological examinations with complete blood count, fasting glucose, glycated hemoglobin and salivary examinations to screen for tumor necrosis factor alpha, interleukin 1, interleukin 6, ostelocalcin, and osteoprotegerin/RANKL will be performed at each evaluation. The data will be statistically evaluated using the most appropriate tests.The results of this study will determine the efficacy of photodynamic therapy as an adjuvant to periodontal treatment in diabetic patients.The protocol for this trial was registered with Clinical Trials registration number NCT01964833 on 14 October 2013.

SUBMITTER: Evangelista EE

PROVIDER: S-EPMC4453758 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Antimicrobial photodynamic therapy combined with periodontal treatment for metabolic control in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial.

Evangelista Erika Elisabeth EE França Cristiane Miranda CM Veni Priscila P de Oliveira Silva Tamires T Gonçalves Rafael Moredo RM de Carvalho Verônica Franco VF Deana Alessandro Melo AM Fernandes Kristianne P S KP Mesquita-Ferrari Raquel A RA Camacho Cleber P CP Bussadori Sandra Kalil SK Alvarenga Letícia Heineck LH Prates Renato Araujo RA

Trials 20150527

<h4>Background</h4>The relationship between diabetes mellitus (DM) and periodontal disease is bidirectional. DM is a predisposing and modifying factor of periodontitis, which, in turn, worsens glycemic control and increases proteins found in the acute phase of inflammation, such as C-reactive protein. The gold standard for the treatment of periodontal disease is oral hygiene orientation, scaling and planing. Moreover, systemic antibiotic therapy may be employed in some cases. In an effort to min ...[more]

PMID: 26013003

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Project description:BackgroundThe increase in the prevalence of type 2 diabetes mellitus (T2DM) and its associated complications is burdensome to the South African health system. Understanding the role of comorbid diseases, such as periodontal disease (PD), and their effect on metabolic control in patients with DM in South Africa will raise awareness about the importance of periodontal interventions among patients with DM in South Africa.ObjectiveThe review will aim to determine the effect of PD on the metabolic control of T2DM in a South African population.MethodsA systematic review of the relationship between PD and metabolic control in patients with T2DM in a South African population will be conducted. Cohort, cross-sectional, and case-controlled studies will be considered in which the outcome of interest is diabetic control. A search will be done in the following sources: EBSCOhost (academic search complete; dentistry and oral sciences), PubMed, ScienceDirect, and the South African National ETD Portal for articles published in English. There will be no limit placed on the date of the publication. The reference list of articles will be reviewed for further inclusion of critical articles. Two independent reviewers (AJ and FK-D) will do study selection, data extraction, and quality analysis. All disputes will be resolved by discussion, and the entire team will verify final decisions.ResultsThe systematic review protocol was registered in the International Prospective Register of Systematic Reviews (PROSPERO). A preliminary search was conducted using the keywords ((perio*) AND (diabet*)) AND ("South Africa"). The review process should be completed by December 2021.ConclusionsThe review will determine the effect of PD on metabolic control in patients with T2DM in South Africa. The outcome would inform health policy to highlight the need to include periodontal care into treatment protocols in patients with T2DM. In this process, the feasibility for future research in this area of interest will also be defined.Trial registrationPROSPERO International Prospective Register of Systematic Reviews CRD42020221064; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=221064.International registered report identifier (irrid)PRR1-10.2196/27471.

Dataset Information

Antimicrobial photodynamic therapy combined with periodontal treatment for metabolic control in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial.

Publications

Antimicrobial photodynamic therapy combined with periodontal treatment for metabolic control in patients with type 2 diabetes mellitus: study protocol for a randomized controlled trial.

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