Effects of Periodontal Therapy in Patients With Metabolic Syndrome (MetS)

Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome

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 Overview

• Status: Completed
• Conditions: Periodontitis; Metabolic Syndrome
• Intervention / Treatment: Procedure: Supragingival Prophylaxis; Procedure: Scaling and root planning

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Minimal Periodontal Treatment (MPT); Once the hopeless teeth have been extracted, randomized patients will receive a periodontal prophylaxis, in the form of supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and, after the last session, placebo capsules (one every 24 h for three days).	Procedure: Supragingival Prophylaxis; Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.
Experimental: Intensive Periodontal Treatment (IPT); Once the hopeless teeth have been extracted, randomized patients will receive 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. During this week the patients will be prescribed local antiseptics (chlorhexidine rinse, 2x, 10 days) and after the last session, systemic antibiotics (azithromycin 500 mgrs, every 24 h for three days).	Procedure: Scaling and root planning; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in C-reactive protein	Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months	Baseline, 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing Pocket Depth	Examination of probing pocket depth will be determined with a periodontal probe and expressed in mm	Baseline, 3 months and 6 months
Change in Clinical Attachment Level	Examination of clinical attachment level will be determined with a periodontal probe and expressed in mm	Baseline, 3 months and 6 months
Change in Plaque Index	Examination of plaque index	Baseline, 3 months and 6 months
Change in Bleeding on Probing	Examination of bleeding on probing	Baseline, 3 months and 6 months
Change in the presence of selected periodontal pathogens	Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum	Baseline, 3 months and 6 months
Change in the total counts of selected periodontal pathogens	By means of anaerobic culture. Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum	Baseline, 3 months and 6 months
Change in the proportions of selected periodontal pathogens	Selected periodontal pathogens: Aggregatibacter actinomycetemcomitans, Tannerella forsythia, P.gingivalis, Prevotella intermedia/nigrescens, Parvimonas micra, Campylobacter rectus and Fusobacterium nucleatum	Baseline, 3 months and 6 months
Change in the concentration of Inflammatory mediators (IL-1β, IL-6, IL-8 and TNF-α) in plasma and gingival crevicular fluid	The inflammatory mediators will be determined by Luminex	Baseline, 3 months and 6 months
Change in the % of Glycated haemoglobin	Analysis of glycated haemoglobin was determined in the Lab of the University Hospital	Baseline, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Colgate Palmolive
• Investigators: Principal Investigator: Mariano Sanz, University Complutense of Madrid

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2012
• Primary Completion (Actual): May 30, 2013
• Study Completion (Actual): July 2, 2018

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Insulin Resistance; Hyperinsulinism; Syndrome; Periodontitis; Metabolic Syndrome
• Other Study ID Numbers: 12/206 CEIC Hospital Clínico

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No