Effects of Periodontal Therapy in Patients With Metabolic Syndrome

Not Applicable

Completed

• Conditions: Periodontitis; Metabolic Syndrome

• Registration Number: NCT03960216
• Lead Sponsor: Universidad Complutense de Madrid

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-28
• Primary Completion: 2013-05-30
• Study Completion: 2018-07-02
• Status Verified: 2019-05
• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Last Update Submitted: 2019-05-23
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in C-reactive protein	Baseline, 3 months and 6 months	Main outcome variable is the change in concentration of C-reactive protein between baseline and 6 months

Secondary Outcome Measures

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