Periodontal and Cardiovascular Diseases Project

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-19

Study Completion Date

2020-02-20

Brief Summary

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The purpose of this study is to investigate whether basic periodontal therapy aim to reduce subgingival levels of Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans, has an impact on the vascular function of patients suffering from established cardiovascular disease.

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Detailed Description

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Design: randomized clinical trial, parallel design, double blinded.

Sample: 120 patients from the Cardiology Department of Hospital Severo Ochoa (Leganés, Madrid) suffering from established cardiovascular disease and generalized moderate/severe periodontitis. Sixty patients will be randomized to test group (scaling and root planing + systemic antimicrobials), and the other 60 subjects will be included in the control group, consisting on delayed periodontal treatment (supragingival prophylaxis + placebo).

Study visits:

Visit 1: screening Visit 2: baseline data collection (medical history, clinical variables, gingival crevicular fluid (GCF) samples, vascular function) Visit 3: panoramic x-ray, blood samples, randomization and first treatment session.

Visit 4: second treatment session. Visit 5: 24 hours inflammatory biomarkers assessment. Visit 6: 7 days inflammatory biomarkers assessment. Visit 7: 1 month follow up (clinical variables) Visit 8: 3 months follow up (clinical variables, vascular function) and supportive periodontal therapy.

Visit 9: 6 months follow up (clinical variables, GCF samples, inflammatory biomarkers, vascular function) and supportive periodontal therapy.

Conditions

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Periodontitis Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Scaling and root planing

Two sessions of scaling and root planing under local anesthesia and oral antiseptics (clorhexidine 0.12% rinse),

Group Type EXPERIMENTAL

Scaling and root planing

Intervention Type PROCEDURE

Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days

Supragingival prophylaxis

Two sessions of supragingival prophylaxis under local anesthesia and an oral rinse with no antiseptic properties.

Group Type PLACEBO_COMPARATOR

Supragingival prophylaxis

Intervention Type PROCEDURE

Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days

Interventions

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Scaling and root planing

Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days

Intervention Type PROCEDURE

Supragingival prophylaxis

Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days

Intervention Type PROCEDURE

Other Intervention Names

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Clorhexidine rinse (0.12%) (Perio-Aid, Dentaid, Spain) Sodium fluoride rinse (Fluor-Aid, Dentaid, Spain)

Eligibility Criteria

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Inclusion Criteria

* (1) patients with established cardiovascular disease (unstable angina or stroke in the previous 3 to 12 months, and left ventricular ejection fraction ≥50%);
* (2) diagnosis of moderate to severe generalized periodontitis (PD\>5mm and marginal bone loss \>30% on at least 50% of the teeth, according to Tonetti et al. 2007);
* (3) presence of at least 3 teeth per quadrant.

Exclusion Criteria

* (1) periodontal treatment in the previous year;
* (2) antibiotic intake in the previous 3 months;
* (3) smokers of ≥10 cigarettes per day;
* (4) pregnancy or breast feeding;
* (5) diabetes mellitus types I or II, with glycosylated hemoglobin values \>7;
* (6) necrotizing periodontal diseases;
* (7) HIV infection;
* (8) chronic intake of NSAID

Eligible Sex

ALL

Accepts Healthy Volunteers

No