Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 May 27:16:229.
doi: 10.1186/s13063-015-0757-3.

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

Erika Elisabeth Evangelista  1 , Cristiane Miranda França  2   3   4 , Priscila Veni  5   6 , Tamires de Oliveira Silva  7 , Rafael Moredo Gonçalves  8 , Verônica Franco de Carvalho  9 , Alessandro Melo Deana  10 , Kristianne P S Fernandes  11   12   13 , Raquel A Mesquita-Ferrari  14   15   16 , Cleber P Camacho  17   18 , Sandra Kalil Bussadori  19   20   21 , Letícia Heineck Alvarenga  22 , Renato Araujo Prates  23   24
Affiliations
Randomized Controlled Trial

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

Erika Elisabeth Evangelista et al. Trials. .

Abstract

Background: 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.

Methods/design: 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.

Discussion: The results of this study will determine the efficacy of photodynamic therapy as an adjuvant to periodontal treatment in diabetic patients.

Trial registration: The protocol for this trial was registered with Clinical Trials registration number NCT01964833 on 14 October 2013.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Flow chart of study design
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. World Health Organization . Definition and diagnosis of diabetes mellitus and intermediate hyperglycemia. Report of a WHO/IDF Consultation. Geneva, Switzerland: World Health Organization; 2006.
    1. Brazil. Diabetes mellitus/ministério da saúde, secretaria de atenção à saúde. In: Brazil. Diabetes mellitus/ministério da saúde, secretaria de atenção à saúde. City: Brasilia; 2006. 56.
    1. Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011;12:46. doi: 10.1186/1745-6215-12-46. - DOI - PMC - PubMed
    1. Armitage GC. Periodontal diagnoses and classification of periodontal diseases 2000. Periodontology. 2004;34:9–21. doi: 10.1046/j.0906-6713.2002.003421.x. - DOI - PubMed
    1. Research, Science and Therapy Committee of the American Academy of Periodontology Treatment of plaque-induced gingivitis, chronic periodontitis, and other clinical conditions. J Periodontol. 2001;72:1790–800. doi: 10.1902/jop.2001.72.12.1790. - DOI - PubMed

Publication types

MeSH terms

Associated data