Effects of Periodontal Therapy in Patients With Metabolic Syndrome

Metabolic Syndrome Clinical Trial

— MetS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03960216
• Other study ID #: 12/206 CEIC Hospital Clínico
• Status: Completed
• Phase: N/A
• Start date: November 28, 2012
• Est. completion date: July 2, 2018

Study information

• Verified date: May 2019
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Periodontitis
• Syndrome

Intervention

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.
• Supragingival Prophylaxis
Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Colgate Palmolive

Outcome

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