Metabolic Syndrome Clinical Trial
— MetSOfficial title:
Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
Verified date | May 2019 |
Source | Universidad Complutense de Madrid |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2, 2018 |
Est. primary completion date | May 30, 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 65 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Universidad Complutense de Madrid | Colgate Palmolive |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Change in Plaque Index | Examination of plaque index | Baseline, 3 months and 6 months | |
Secondary | Change in Bleeding on Probing | Examination of bleeding on probing | Baseline, 3 months and 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Change in the concentration of Inflammatory mediators (IL-1ß, IL-6, IL-8 and TNF-a) in plasma and gingival crevicular fluid | The inflammatory mediators will be determined by Luminex | Baseline, 3 months and 6 months | |
Secondary | 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 |
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