Metabolic Syndrome and Periodontitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Federal University of Rio Grande do Sul
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Patricia Weidlich, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT02012842
First received: October 30, 2013
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The aim of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome. There will be a randomized clinical trial with patients from the clinic of Endocrinology - Prediabetes (Hospital de Clinicas de Porto Alegre) and outpatient dental clinic of the Faculty of Dentistry, Federal University of Rio Grande do Sul (UFRGS), who have a diagnosis of metabolic syndrome and diagnosis of periodontitis. The clinical trial will consist of an arm where it will be immediately periodontal treatment (test group) and another arm which will be held later periodontal treatment (control group). The study will last six months , and after this period, the control group will receive the same treatment to the test group . A socio-demographic questionnaire will be applied by a trained interviewer , so that data on income, education , behavioral habits , medical and dental history . Complete periodontal examination will be conducted at 6 sites per tooth for all teeth present at baseline and 3 and 6 months after periodontal treatment . In addition to the tests required for the diagnosis of metabolic syndrome , will be asked the same blood tests at 3 and 6 months after periodontal treatment (total cholesterol , LDL and HDL , fasting glucose , triglycerides , C-reactive protein). Aliquots of plasma from blood collected in each experimental point are stored at -80 ° C for analysis of interleukin- 6, Tumor Necrosis Factor- α (TNF-α) , Glucagon Like Peptide-1 (GLP-1) and adiponectin. At each clinical examination will be collected gingival crevicular fluid , supra and subgingival biofilm . Versions of the questionnaires validated in Brazil (OHIP-14)and WHOQoL Bref will be applied to assess quality of life at baseline and after 6 months of the study . The primary outcome will be change in glycated hemoglobin and secondary outcomes will be changes in serum fibrinogen and C-reactive protein.The hypothesis of this study considers that periodontal treatment can alter the serum levels of C-reactive protein, fibrinogen and glycosylated hemoglobin in patients with metabolic syndrome and thereby contribute to improved quality of life. The objective of this study is to evaluate the effect of periodontal treatment on systemic inflammation and quality of life of individuals with metabolic syndrome.


Condition Intervention Phase
Metabolic Syndrome
Periodontal Disease
Inflammatory Response
Other: Non surgical periodontal treatment
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Periodontal Treatment on Quality of Life in Patients With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Changes at glycated hemoglobin. [ Time Frame: This measure will be measured in 0 (baseline), 3 and 6 months after periodontal treatment. ] [ Designated as safety issue: No ]
    Glycated hemoglobin will be measured by collecting blood tests at 0, 3 and 6 months after the periodontal treatment (test and control)


Secondary Outcome Measures:
  • Changes at Protein C reactive and serum fibrinogen. [ Time Frame: These outcomes will be measured at 0, 3 and 6 months after periodontal treatment. ] [ Designated as safety issue: No ]
    Protein C reactive and serum fibrinogen will be measured by collecting blood tests at 0, 3 and 6 months after the periodontal treatment (test and control).


Estimated Enrollment: 158
Study Start Date: May 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Immediate periodontal treatment
Strict supragingival plaque control and non surgical periodontal treatment immediately after the baseline examination(test group).
Other: Non surgical periodontal treatment
Treatment of gingivitis: excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth, supragingival calculus removal. Oral hygiene instruction, training and motivation will be given at each appointment. Treatment of periodontitis: subgingival scaling and root planing under local anesthesia.
Other Names:
  • strict supragingival plaque control
  • non surgical periodontal therapy
  • scaling and root planning
Delayed periodontal treatment
Strict plaque control and non surgical periodontal treatment 6 months after the baseline examination (control group).
Other: Non surgical periodontal treatment
Treatment of gingivitis: excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth, supragingival calculus removal. Oral hygiene instruction, training and motivation will be given at each appointment. Treatment of periodontitis: subgingival scaling and root planing under local anesthesia.
Other Names:
  • strict supragingival plaque control
  • non surgical periodontal therapy
  • scaling and root planning

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older than or equal to 18
  • at least 10 teeth
  • diagnosis of periodontitis ( > 2 interproximal sites with PD> 5 mm in distinct teeth or > 2 interproximal sites with PI > 4mm in different teeth of according to Page and Eke , 2007)
  • have metabolic syndrome (The patient must present at least among the following three criteria: (a ) waist circumference greater than 90 inches for men and for women over 80 , (b) triglycerides ≥ 150 mg / dl ( 1.7 mmol / L ) or as a treatment for hypertriglyceridemia (c ) HDL cholesterol less than 40 mg / dL for men and less than 50 mg / dl for women or being treated for dyslipidemia ; ( d ) hypertension at examination ( systolic ≥ 130 mm Hg and diastolic blood pressure ≥ 85 mm Hg ) or hypertension diagnosis or past history or treatment for hypertension , (e ) plasma glucose ≥ 100 mg / dl or a diagnosis of diabetes or use of medication for glycemic control)

Exclusion Criteria:

  • have periodontal treatment performed in the last six months
  • have used antibiotics in the last 3 months
  • have indication of antibiotic prophylaxis for dental care
  • be pregnant
  • chronic use of systemic corticosteroids
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02012842

Contacts
Contact: Bruna Greggianin, PhD student +555198173335 bruna.greggianin@gmail.com
Contact: Patricia Weidlich, Associate Professor +555133085318 patricia.weidlich@ufrgs.br

Locations
Brazil
Faculty of Dentistry, Federal University of Rio Grande do Sul and Hospital de Clinicas de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90035-003
Contact: Bruna F Greggianin    5198173335    bruna.greggianin@gmail.com   
Principal Investigator: Rui V Oppermann, PhD         
Principal Investigator: Fernando Gerchman, PhD         
Faculdade de Odontologia da UFRGS Recruiting
Porto Alegre, RS, Brazil, 90035003
Sub-Investigator: Patricia Weidlich, Investigator         
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Rui V Oppermann, PhD Federal University of Rio Grande do Sul
Principal Investigator: Fernando Gerchman, PhD Hospital de Clínicas de Porto Alegre
  More Information

No publications provided

Responsible Party: Patricia Weidlich, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02012842     History of Changes
Other Study ID Numbers: 060173
Study First Received: October 30, 2013
Last Updated: July 10, 2014
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of Rio Grande do Sul:
Metabolic Syndrome
Periodontal Disease
Periodontal therapy
inflammatory markers
C reactive protein
serum fibrinogen
glycated hemoglobin

Additional relevant MeSH terms:
Periodontal Diseases
Periodontitis
Metabolic Syndrome X
Mouth Diseases
Stomatognathic Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 31, 2014