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Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic

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ClinicalTrials.gov Identifier: NCT02220751
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : August 20, 2014
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Priscila Paganini Costa, University of Sao Paulo

Brief Summary:
The purpose of the study was to monitor the activity of periodontal disease and suggest potential biomarkers related to active periodontal disease in patients with chronic periodontitis (PD) associated or not with type 2 diabetes mellitus (DM), based on the evaluation of the profile of gene expression of periodontal sites and the evaluation of inflammatory salivary proteins. Two hundred and five periodontal patients were enrolled, but only 41 exhibited ≥ 1 mm attachment loss in at least three periodontal site (active sites) 2 months after non-surgical periodontal therapy. The final sample was: 21 patients with chronic periodontitis (PD group) and 20 with chronic periodontitis and diabetes (PD+DM group). Fifteen periodontal- and systemically healthy patients were included as control group. Saliva collection, glycated hemoglobin measurement, periodontal examination and radiographs were conducted before and 2 months after non-surgical periodontal therapy. Radiographic subtraction was performed from pairs of the radiographs. Measurements of the areas with density loss were recorded. Gingival biopsies of active and non-active sites with similar clinical parameters were harvested for Real Time Polymerase Chain Reaction Array gene expression analysis. Saliva samples were analyzed by Multiplex Cytokine Profiling Immunoassay for analysis of protein expression. The clinical attachment loss mean was higher in the PD+DM group (p<0.05). There was a high correlation between clinical attachment loss and darkened radiographic areas in active sites of the PD group and PD+DM group. When compared PD group to PD+DM, patients with diabetes had an up-regulated profile. Active sites of the PD group showed nine genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. Active sites of the PD+DM group showed six genes (specific chemokines, interleukins and receptors) differentially expressed with an up-regulated profile. After periodontal therapy, there was a reduction of some salivary proteins in both periodontal groups, but not significant. In conclusion, it was possible to identify genes differentially expressed in active sites from both groups, which may be considered useful in indicating potential biomarkers for the diagnosis of periodontitis; salivary proteins show a trend in distinguishing the standard of health and disease and may be used in the future as potential biomarkers of periodontitis with or without diabetes.

Condition or disease Intervention/treatment Phase
Periodontitis Type 2 Diabetes Mellitus Drug: non-surgical periodontal therapy + systemic doxycycline Procedure: Non-surgical periodontal therapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Diagnostic Biomarkers Related to Periodontal Disease Activity in Diabetic
Study Start Date : March 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : June 2012

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Arm Intervention/treatment
Placebo Comparator: chronic periodontitis
Non-surgical periodontal therapy.
Procedure: Non-surgical periodontal therapy
A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy. The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis.
Other Name: Scaling and root planning

Active Comparator: Chronic periodontitis + type 2 diabetes
Non-surgical periodontal therapy + systemic doxycycline non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before first scaling and root planning session.
Drug: non-surgical periodontal therapy + systemic doxycycline

A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy. The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis.

Non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before the first scaling and root planning session. Patients of the PD group had no access to information about antibiotics administration to patients of the PD+DM group.

Other Name: Doxilegrand, Legrand, São Bernardo do Campo, SP, Brazil.

No Intervention: Control
Periodontal- and systemically healthy patients were included as control group.



Primary Outcome Measures :
  1. clinical attachment level [ Time Frame: baseline and two months ]
    relative clinical attachment level (rCAL) was recorded at six sites per tooth with the aid of a computerized periodontal probe.


Secondary Outcome Measures :
  1. Gene expression [ Time Frame: Two months ]
    Gingival tissue samples were obtained from periodontal sites (active or non-active) of the each patient in both groups during regular periodontal surgery. The samples are immediately submerged into liquid nitrogen to be then stored at -80º Celsius for RNA extraction and cDNA synthesis. The Real Time-PCR Array allowed simultaneous analysis of 84 genes involved in specific signaling pathways, including specific human inflammatory cytokines and receptors.

  2. Salivary proteins levels [ Time Frame: baseline and two months ]
    Non-stimulated whole expectorated saliva was collected (~ 3 ml) from each subject into sterile tubes and stored at -80º Celsius. The salivary inflammatory proteins levels were identified simultaneously using Multiplex Cytokine Profiling Assay, which allows the simultaneous detection of multiple analytes in saliva sample size.


Other Outcome Measures:
  1. Probing pocket depth [ Time Frame: baseline and two months ]
    It was recorded at six sites per tooth with the aid of a computerized periodontal probe.

  2. Bleeding on probing [ Time Frame: baseline and two months ]
    It was recorded at six sites per tooth with the aid of a computerized periodontal probe, and it was assessed according to presence or absence of bleeding up to 20 seconds after probing.

  3. Plaque index [ Time Frame: baseline and two months ]
    It was recorded at four sites per tooth to assess presence or absence of dental biofilm.

  4. Glycated hemoglobin level [ Time Frame: baseline and two months ]
    Metabolic control assessment

  5. Density loss [ Time Frame: baseline and two months ]
    A complete series of radiographs was taken in each patient at baseline, using the paralleling technique. Two months after periodontal therapy, radiographs were taken with the same technique in teeth with active periodontal sites. The radiographs were digitized in tagged image file format (TIFF) on a scanner. Digital subtraction radiographs were performed with the baseline and 2-month radiographs using specific software. Changes between radiographs were depicted as a darkened area for loss of alveolar bone mass. These areas were measured (mm2) using specific measurements software.



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults aged between 35 to 65 years old;
  • a minimum of 14 natural teeth, 10 of which should be posterior teeth;
  • periodontitis case definition was the presence of five teeth with a probing pocket depth of ≥ 5 mm and clinical attachment loss of ≥ 3 mm;
  • type 2 diabetes for at least 5 years and with glycated hemoglobin level > 7%.

Exclusion Criteria:

  • smoking within the last 5 years;
  • pregnancy or lactating;
  • use of antibiotics or periodontal therapy in the previous six months;
  • concomitant medical therapy, except for diabetic condition;
  • other inflammatory conditions;
  • major diabetic complications such as retinopathy, nephropathy, neuropathy and atherosclerosis.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220751


Locations
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Brazil
Mario Taba Jr
Ribeirao Preto, Sao Paulo, Brazil, 14040-904
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Priscila P Costa, PhD Department of Oral Surgery and Periodontology - Ribeirão Preto School of Dentistry, University of São Paulo
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Responsible Party: Priscila Paganini Costa, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02220751    
Other Study ID Numbers: 2008/11033-9
2008/11033-9 ( Other Grant/Funding Number: FAPESP2008/11033-9 )
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Priscila Paganini Costa, University of Sao Paulo:
Periodontal Attachment Loss
Genes
Saliva
Diagnosis
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Doxycycline
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents