Effects of Periodontal Therapy in Patients With Metabolic Syndrome

Study Overview
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Brief Summary
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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.

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

Conditions
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Periodontitis, Metabolic Syndrome

Intervention / Treatment
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* Procedure: Scaling and root planning
* Procedure: Supragingival Prophylaxis


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Minimal Periodontal Treatment (MPT)<br>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<br>* Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.<br>|
| Experimental: Intensive Periodontal Treatment (IPT)<br>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<br>* 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.<br>|

What is the study measuring?
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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 |