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

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 standar...

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Published in:Current controlled trials in cardiovascular medicine 2015-05, Vol.16 (1), p.229-229, Article 229
Main Authors: Evangelista, Erika Elisabeth, França, Cristiane Miranda, Veni, Priscila, de Oliveira Silva, Tamires, Gonçalves, Rafael Moredo, de Carvalho, Verônica Franco, Deana, Alessandro Melo, Fernandes, Kristianne P S, Mesquita-Ferrari, Raquel A, Camacho, Cleber P, Bussadori, Sandra Kalil, Alvarenga, Letícia Heineck, Prates, Renato Araujo
Format: Article
Language:English
Subjects:
Antibiotics
Antimicrobial agents
Bacterial infections
Biofilms
Biomarkers - blood
Blood
Blood Glucose - metabolism
Brazil
C-reactive protein
Cancer
Care and treatment
Chronic Disease
Clinical Protocols
Clinical trials
Combined Modality Therapy
Dental plaque
Dental Scaling
Dextrose
Diabetes
Diabetes Mellitus, Type 2 - blood
Diabetes Mellitus, Type 2 - diagnosis
Diabetes Mellitus, Type 2 - drug therapy
Diabetes therapy
Diabetics
Disease
Double-Blind Method
Drug therapy
Glucose
Glycated Hemoglobin A - metabolism
Glycosylated hemoglobin
Gum disease
Health aspects
Humans
Infections
Inflammation
Inflammation Mediators - blood
Insulin
Interleukins
Lasers
Medical examination
Metabolism
Methylene Blue - adverse effects
Methylene Blue - therapeutic use
Microorganisms
Oral hygiene
Patient outcomes
Patients
Periodontal Diseases - blood
Periodontal Diseases - diagnosis
Periodontal Diseases - drug therapy
Periodontal Diseases - microbiology
Photochemotherapy
Photochemotherapy - adverse effects
Photochemotherapy - methods
Photodynamic therapy
Photosensitizing Agents - adverse effects
Photosensitizing Agents - therapeutic use
Proteins
Research Design
Research ethics
Root Planing
Saliva - metabolism
Study Protocol
Time Factors
Treatment Outcome
Type 2 diabetes
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Summary: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 μg/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.
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-015-0757-3