Metabolic Syndrome and Periodontitis

NCT02012842 | Unknown DMC

• 1 other identifier: 060173
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Metabolic Syndrome; Periodontal Disease; Inflammatory Response

Keywords

Metabolic Syndrome; Periodontal Disease; Periodontal therapy; inflammatory markers; C reactive protein; serum fibrinogen; glycated hemoglobin

Outcome Measures

Primary Outcomes (1)

• Changes at glycated hemoglobin.

  Glycated hemoglobin will be measured by collecting blood tests at 0, 3 and 6 months after the periodontal treatment (test and control)

  This measure will be measured in 0 (baseline), 3 and 6 months after periodontal treatment.

Secondary Outcomes (1)

• Changes at Protein C reactive and serum fibrinogen.

  These outcomes will be measured at 0, 3 and 6 months after periodontal treatment.

Study Arms (2)

Immediate periodontal treatment

ACTIVE COMPARATOR

Strict supragingival plaque control and non surgical periodontal treatment immediately after the baseline examination(test group).

Other: Non surgical periodontal treatment

Delayed periodontal treatment

OTHER

Strict plaque control and non surgical periodontal treatment 6 months after the baseline examination (control group).

Other: Non surgical periodontal treatment

Interventions

Non surgical periodontal treatment OTHER

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.

Also known as: strict supragingival plaque control, non surgical periodontal therapy, scaling and root planning

Delayed periodontal treatment; Immediate periodontal treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (2)

Faculty of Dentistry, Federal University of Rio Grande do Sul and Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Faculdade de Odontologia da UFRGS

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

Location

MeSH Terms

Conditions

Metabolic Syndrome; Periodontal Diseases

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Rui V Oppermann, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

• Fernando Gerchman, PhD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Patricia Weidlich

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: December 16, 2013
• Study Start: May 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: December 1, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Locations

BR (2)