Effects of Periodontal Therapy in Patients With Metabolic Syndrome

NCT ID: NCT03960216

Last Updated: 2019-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-28
• Study Completion Date: 2018-07-02

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.

Conditions

Periodontitis; Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Minimal Periodontal Treatment (MPT)

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).

Group Type: SHAM_COMPARATOR

Supragingival Prophylaxis

Intervention Type: PROCEDURE

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

Intensive Periodontal Treatment (IPT)

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).

Group Type: EXPERIMENTAL

Scaling and root planning

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Supragingival Prophylaxis

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mariano Sanz

Role: PRINCIPAL_INVESTIGATOR

University Complutense of Madrid

Other Identifiers

12/206 CEIC Hospital Clínico

Identifier Type: -

Identifier Source: org_study_id