NCT03960216

Effects of Periodontal Therapy in Patients With Metabolic Syndrome

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Universidad Complutense de Madrid · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontitis
• Metabolic Syndrome

Interventions

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

Timeline

• Start date: 2012-11-28
• Primary completion: 2013-05-30
• Completion: 2018-07-02
• First posted: 2019-05-23
• Last updated: 2019-05-28