Effects of Periodontal Therapy in Patients With Metabolic Syndrome
- Conditions
- PeriodontitisMetabolic Syndrome
- Interventions
- Procedure: Supragingival ProphylaxisProcedure: Scaling and root planning
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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).
- 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
- Arm && Interventions
Group Intervention Description Minimal Periodontal Treatment (MPT) Supragingival Prophylaxis 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). Intensive Periodontal Treatment (IPT) Scaling and root planning 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).
- 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