Study 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
Periodontal and Cardiovascular Diseases Project
Impact of Basic Periodontal Therapy in the Levels of Porphyromonas Gingivalis and Aggregatibacter Actinomycetemcomitans Subgingival and Its Association With Vascular Function
2 other identifiers
interventional
36
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2016
CompletedFirst Submitted
Initial submission to the registry
March 17, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 19, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2020
CompletedMay 9, 2024
May 1, 2024
4 years
March 17, 2016
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Day 0 (Baseline), Day 90, Day 180
Secondary Outcomes (13)
Carotid artery atherosclerosis
Day 0 (Baseline), Day 90, Day 180
Periodontal pocket probing depth
Day 0 (baseline), Day 30, Day 90, Day 180
Gingival recession
Day 0 (baseline), Day 30, Day 90, Day 180
Plaque index
Day 0 (baseline), Day 30, Day 90, Day 180
Bleeding on probing index
Day 0 (baseline), Day 30, Day 90, Day 180
- +8 more secondary outcomes
Study Arms (2)
Scaling and root planing
EXPERIMENTALTwo sessions of scaling and root planing under local anesthesia and oral antiseptics (clorhexidine 0.12% rinse),
Supragingival prophylaxis
PLACEBO COMPARATORTwo sessions of supragingival prophylaxis under local anesthesia and an oral rinse with no antiseptic properties.
Interventions
Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days
Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days
Eligibility Criteria
You may qualify if:
- (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.
You may not qualify if:
- (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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Complutense de Madridlead
- Instituto de Salud Carlos IIIcollaborator
Study Sites (2)
Severo Ochoa Hospital
Leganés, Madrid, Spain
Faculty of dentistry, Complutense University Madrid
Madrid, 28040, Spain
Related Publications (2)
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.
PMID: 17329698BACKGROUNDMolina 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.
PMID: 39996093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariano Sanz, Professor
Faculty of Dentistry, Complutense University of Madrid
- PRINCIPAL INVESTIGATOR
David Herrera, Professor
Faculty of Dentistry, Complutense University of Madrid
- STUDY DIRECTOR
Elena Figuero, Professor
Faculty of Dentistry, Complutense University of Madrid
- STUDY CHAIR
María Molina, Doctor
Servicio de Cardiología, Hospital Universitario Severo Ochoa
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 17, 2016
First Posted
March 23, 2016
Study Start
February 19, 2016
Primary Completion
February 19, 2020
Study Completion
February 20, 2020
Last Updated
May 9, 2024
Record last verified: 2024-05