Clinical trial NCT03960216: Effects of Periodontal Therapy in Patients With Metabolic Syndrome
Official title: Effects of Periodontal Therapy on Local and Systemic Markers of Inflammation in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Metabolic Syndrome
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
First posted: 2019-05-23
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in C-reactive protein
timeFrame: Baseline, 3 months and 6 months
Secondary outcomes:
measure: Change in Probing Pocket Depth
timeFrame: Baseline, 3 months and 6 months
measure: Change in Clinical Attachment Level
timeFrame: Baseline, 3 months and 6 months
measure: Change in Plaque Index
timeFrame: Baseline, 3 months and 6 months
measure: Change in Bleeding on Probing
timeFrame: Baseline, 3 months and 6 months
measure: Change in the presence of selected periodontal pathogens
timeFrame: Baseline, 3 months and 6 months
measure: Change in the total counts of selected periodontal pathogens
timeFrame: Baseline, 3 months and 6 months
measure: Change in the proportions of selected periodontal pathogens
timeFrame: Baseline, 3 months and 6 months
measure: Change in the concentration of Inflammatory mediators (IL-1β, IL-6, IL-8 and TNF-α) in plasma and gingival crevicular fluid
timeFrame: Baseline, 3 months and 6 months
measure: Change in the % of Glycated haemoglobin
timeFrame: Baseline, 3 months and 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University Complutense of Madrid
name: Mariano Sanz
role: PRINCIPAL_INVESTIGATOR
References: