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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03960216
Other study ID # 12/206 CEIC Hospital Clínico
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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