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PeriodontitisNCT02716259

Periodontal and Cardiovascular Diseases Project

A study testing Scaling and root planing and Supragingival prophylaxis in people with Periodontitis and Cardiovascular Diseases, run by Universidad Complutense de Madrid at 2 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Periodontitis, Cardiovascular Diseases
What is being tested?
Scaling and root planing and Supragingival prophylaxis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
36 participants
Where
2 sitesSpain
Study dates
19 Feb 2016to 20 Feb 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • (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.

Who cannot join

  • (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

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Severo Ochoa Hospital

    Leganés, Madrid

  • Faculty of dentistry, Complutense University Madrid

    Madrid, 28040

Other trials in Spain

About this study

Official title: Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function

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.

Read the detailed description

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.

Being tested
Scaling and root planing, Supragingival prophylaxis
Keywords
Periodontitis, Cardiovascular diseases, Bacteremia, Scaling and root planing, Flow-mediated dilation, carotid intima-media thickness, Porphyromonas gingivalis, Aggregatibacter actinomycetemcomitans
Medical subject headings
Periodontitis, Cardiovascular Diseases, Bacteremia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Scaling and root planingProcedure or surgery

    Also called Clorhexidine rinse (0.12%) (Perio-Aid, Dentaid, Spain)

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

  • Supragingival prophylaxisProcedure or surgery

    Also called Sodium fluoride rinse (Fluor-Aid, Dentaid, Spain)

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

Study groups in NCT02716259
Study groupRoleWhat they receive
Scaling and root planingExperimentalTwo sessions of scaling and root planing under local anesthesia and oral antiseptics (clorhexidine 0.12% rinse),
Receives: Procedure: Scaling and root planing
Supragingival prophylaxisPlacebo comparatorTwo sessions of supragingival prophylaxis under local anesthesia and an oral rinse with no antiseptic properties.
Receives: Procedure: Supragingival prophylaxis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flow mediated dilation of the brachial artery

    Endothelium-dependent vasodilatation of the brachial artery assessed by means of ultrasound imaging with the use of a 7-MHz linear probe and vessel diameter measurements. Dilatation was quantified as the change in percentage form a baseline measurement and a second measurement taken after 5 minutes of flow ischemia induced with a sphygmomanometer cuff placed on the forearm.

    Measured: Day 0 (Baseline), Day 90, Day 180

Secondary outcomes (13)

  1. Carotid artery atherosclerosis

    Intima-media thickness of the carotid artery assessed by means of ultrasound imaging with the use of a 7-MHz linear probe and an automated imaging software.

    Measured: Day 0 (Baseline), Day 90, Day 180

  2. Periodontal pocket probing depth

    Distance from the gingival margin to the base of the periodontal pocket, measured in 6 sites per tooth with a periodontal probe UNC-15.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  3. Gingival recession

    Distance from the gingival margin to the cementum-enamel junction, measured in 6 sites per tooth with a periodontal probe UNC-15.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  4. Plaque index

    Presence or absence of dental plaque around teeth, measured in 6 sites per tooth with a periodontal probe of the University of North Caroline (UNC)-15.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  5. Bleeding on probing index

    Presence or absence of bleeding 30 seconds after probing, measured in 6 sites per tooth with a periodontal probe UNC-15.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  6. Suppuration on probing index

    Presence or absence of gingival suppuration 30 seconds after probing, measured in 6 sites per tooth with a periodontal probe UNC-15.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  7. Dental mobility

    Presence of dental mobility, recorded according to Miller´s classification: 0: absence of mobility; 1: horizontal mobility <1mm; 2: horizontal mobility >1mm; 3: horizontal and vertical mobility.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  8. Furcation lesions

    Presence of periodontal attachment loss in the furcation area of multi-rooted teeth, recorded according to Lindhe´s classification: I: the probe penetrates less than one third of the horizontal dimension of the tooth; II: the probe penetrates more than one third of the horizontal dimension of the tooth; III: the probe penetrates through and through the tooth.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  9. Number of present teeth

    Number of teeth present in mouth.

    Measured: Day 0 (baseline), Day 30, Day 90, Day 180

  10. Radiographic bone loss

    Percentage of bone loss around teeth measured in an orthopantomography (<30%, 30-50%, >50%).

    Measured: Day 0 (baseline)

  11. Bacteria in gingival crevicular fluid

    Total counts (CFU/ml) and percentage of the flora of anaerobic bacteria present in gingival crevicular fluid. Samples will be processed by means of culture and quantitative polymerase chain reaction

    Measured: Day 0 (baseline), Day 180

  12. Bacteria in blood samples

    Total counts (CFU/ml) and percentage of the flora of anaerobic bacteria present in blood samples before and 10 minutes after the intervention. Samples will be processed by means of culture and quantitative polymerase chain reaction

    Measured: Day 1 (pre and post-therapy)

  13. Inflammatory biomarkers in serum samples

    Levels of inflammatory biomarkers (interleukin 6, C reactive protein, e-selectin) and coagulation factors (d-dimer, prothrombin, fibrinogen, Von Willebrand factor) in serum, assessed by means of Luminex technique (Bio-Plex Pro-Assays kit).

    Measured: Day 1, Day 3, Day 10, Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2016 (estimated)
  2. Study start19 Feb 2016
  3. Primary completion19 Feb 2020
  4. Study completion20 Feb 2020

Why it stopped: Study population was insufficient to provide an adequate pool of patients. All included patients were treated and followed, but the overall desired sample size was not achieve

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02716259
Sponsor's protocol ID
14/120-E_BS
Other IDs
PI11/00542
Status last verified
May 2024
First submitted
17 Mar 2016
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Tonetti MS, D'Aiuto F, Nibali L, Donald A, Storry C, Parkar M, Suvan J, Hingorani AD, Vallance P, Deanfield J. Treatment of periodontitis and endothelial function. N Engl J Med. 2007 Mar 1;356(9):911-20. doi: 10.1056/NEJMoa063186.

    PubMed 17329698

  • Molina A, Ambrosio N, Molina M, Montero E, Virto L, Herrera D, Figuero E, Sanz M. Effect of periodontal therapy on endothelial function and serum biomarkers in patients with periodontitis and established cardiovascular disease: a pilot study. Front Oral Health. 2025 Feb 10;6:1488941. doi: 10.3389/froh.2025.1488941. eCollection 2025.

    PubMed 39996093

Questions about this trial

What is this clinical trial studying?

A study testing Scaling and root planing and Supragingival prophylaxis in people with Periodontitis and Cardiovascular Diseases, run by Universidad Complutense de Madrid at 2 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Study population was insufficient to provide an adequate pool of patients. All included patients were treated and followed, but the overall desired sample size was not achieve). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flow mediated dilation of the brachial artery (time frame: Day 0 (Baseline), Day 90, Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02716259, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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