Effects of Periodontal Therapy in Patients With Metabolic Syndrome

Universidad Complutense de Madrid60 enrolled

Overview

A 6-month, parallel-arm, investigator-masked, randomized clinical trial was conducted in patients with MetS and severe periodontitis. Participants were randomly assigned to an Intensive Periodontal Treatment group (IPT; scaling and root planing and azithromycin capsules 500mg/24h/3days) or to a Minimal Periodontal Treatment group (MPT; professional plaque removal and placebo capsules). Blood and subgingival microbiological samples were collected at baseline, 3 and 6 months after therapy. The primary outcome was between-group difference in C-reactive protein (CRP). Secondary outcomes included HbA1c, lipids, α-1 antitrypsin, fibrinogen levels and subgingival microbiota assessment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Periodontitis Metabolic Syndrome

Interventions

Patients received non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of Metabolic Syndrome according to the IDF definition * at least 16 teeth * at least eight sites with probing pocket depth (PPD) ≥ 6 mm and four sites with clinical attachment loss ≥ 5 mm, distributed in at least two different quadrants (Koromantzos et al. 2012). Exclusion Criteria: * They are not medically controlled for obesity and cardiovascular risk factors at the start of the study. For ethical reasons, patient inclusion must be delayed at least 3 months when begins a pharmacological treatment. * They had history of kidney disease with Cr\>1.2, CKD-EPI\< 70 mil/min, or proteinuria \> 300 mg/24 hours or 0.3 mg/grCr in isolated sample. * They had history of chronic lung disease, or acute disease during the previous 3 months. * They had history of stroke during the previous 3 months, myocardial infarction or revascularization during the previous 6 months, or recent angor pectoris history. * They had history of known peripheral artery disease, or chronic heart failure. * They had surgical treatment during the previous 3 months. * They had any disease that conditions compliance along the study, such as alcoholism or psychiatric disorder. * They had a history of systemic antibiotic usage over the previous 3 months. * They had non-surgical periodontal treatment during the previous 6 months; or surgical periodontal treatment over the previous 12 months.

Outcomes

Primary Outcomes

Change in C-reactive protein

Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months