Evidence map›Paper›PMID 26013003›Full record

Trial reportTrials2015

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, Cristiane Miranda França, Priscila Veni, Tamires de Oliveira Silva, Rafael Moredo Gonçalves, Verônica Franco de Carvalho, Alessandro Melo Deana, Kristianne P S Fernandes, Raquel A Mesquita-Ferrari, Cleber P Camacho and 3 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01964833 (Combination of Photodynamic Therapy and Periodontal Treatment in Patients With Type 2 Diabetes Mellitus), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.3field-weighted citation impact, top 43% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01964833 nacompletednot on this map

Combination of Photodynamic Therapy and Periodontal Treatment in Patients With Type 2 Diabetes Mellitus: Randomized, Double-blind Clinical Trial

TypeinterventionalSponsorUniversity of Nove de JulhoRan2013 to 2015Enrolled44ConditionsPeriodontitis, Diabetes Mellitus Type 2ArmsPeriodontal treatment, Periodontal treatment and PDT
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 9 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 1 institution in 1 country.

Erika Elisabeth EvangelistaProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. erikacatalani@ig.com.br.
Cristiane Miranda FrançaProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. cristianepatologia@uninove.br.
Priscila VeniProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. priscilaveni@hotmail.com.
Tamires de Oliveira SilvaProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. tamires.oliveira@uninove.edu.br.
Rafael Moredo GonçalvesProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. rafamoredo@hotmail.com.
Verônica Franco de CarvalhoSchool of Dentistry, Nove de Julho University UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. vecarvalho@gmail.com.
Alessandro Melo DeanaProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. amdeana@gmail.com.
Kristianne P S FernandesProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. kristianneporta@uninove.br.
Raquel A Mesquita-FerrariProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. raquel.mesquita@gmail.com.
Cleber P CamachoSchool of Medicine, Nove de Julho University UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. camacho@uninove.br.
Sandra Kalil BussadoriProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. sandrakalil@uninove.br.
Letícia Heineck AlvarengaProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. leclimaco@hotmail.com.
Renato Araujo PratesProgram in Biophotonics Applied to Health Sciences, University Nove de Julho, UNINOVE, Rua Vergueiro 235/249 - Liberdade, São Paulo, SP, 01504-001, Brazil. pratesra@uninove.br.
Universidade Nove de Julho · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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/

designThe 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 registrationThe protocol for this trial was registered with Clinical Trials registration number NCT01964833 on 14 October 2013.

Indexed as

BiomarkersBlood GlucoseBrazilChronic DiseaseClinical ProtocolsCombined Modality TherapyDental ScalingDiabetes Mellitus, Type 2Double-Blind MethodGlycated HemoglobinHumansInflammation MediatorsMethylene BluePeriodontal DiseasesPhotochemotherapyPhotosensitizing AgentsBiomarkersBlood GlucoseGlycated Hemoglobinhemoglobin A1c protein, humanInflammation MediatorsMethylene BluePhotosensitizing Agents

Identifiers

PMID26013003
PMCPMC4453758
OpenAlexW1535065474

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.