Clinical trial NCT02131922: Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control
Official title: Study of the Effects of Intensive Treatment of Periodontitis on Blood Pressure Control and Vascular Function
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Hypertension
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2014-05-06
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypertensive patients with chronic periodontitis will be randomized to either intensive treatment or supragingival hygienic treatment and the effects on blood pressure will be identified.


Eligibility criteria: Inclusion Criteria:

* Periodontitis with three or more periodontal pockets with a probing depth (PD) \> 5mm
* Bleeding of these periodontal pockets on probing
* Have at least 20 natural teeth
* Provide informed consent and willingness to cooperate with the study protocol
* Age \>25 years old
* Absence of other significant oral infections.
* Primary Hypertension on stable treatment

Exclusion Criteria:

* Clinical symptoms of acute inflammatory disorders incl flu, rhinitis, sinusitis etc. within past 3 weeks
* Hospitalization for any reason within the past 3 months; Life expectancy of \< 3 years;
* Allergic disorders; History of chronic infectious disease, Chronic Obstructive Pulmonary Disease (COPD), tuberculosis; chronic hepatitis B or C infection; interstitial pneumonitis, bronchiectasis; known chronic pericardial effusion, pleural effusion, or ascites; liver disease;
* Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
* Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
* Non-basal cell malignancy or treated myelo or lymphoproliferative disease within the past 5 years;
* Known HIV positive; Immunizations within past 3 months
* Individual requires chronic oxygen support or mechanical ventilation other than nocturnal respiratory support for sleep apnea.
* Primary pulmonary hypertension.
* Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
* Individual is pregnant or nursing
* History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week

Primary outcomes:
measure: Blood Pressure Change
timeFrame: 3 months
Secondary outcomes:
measure: Flow Mediated Dilatation
timeFrame: 3 months
Other outcomes:
measure: Leukocyte Immunophenotype and Cytokine measurement
timeFrame: 3 months
measure: Periodontal Health Score - Probing Depth
timeFrame: 3 months
measure: Periodontal Health Score - CAL - Clinical Attachment Loss
timeFrame: 3 months
measure: The Community Periodontal Index of Treatment Needs Index
timeFrame: 3 months
measure: Gingival Index
timeFrame: 3 months
Locations:
city: Krakow
country: Poland
facility: J. Dietl Hospital, Department of Internal and Agricultural Medicine, Jagiellonian University
city: Krakow
country: Poland
facility: Jagiellonian University Dental Clinic
Study officials:
References:
citation: Czesnikiewicz-Guzik M, Osmenda G, Siedlinski M, Nosalski R, Pelka P, Nowakowski D, Wilk G, Mikolajczyk TP, Schramm-Luc A, Furtak A, Matusik P, Koziol J, Drozdz M, Munoz-Aguilera E, Tomaszewski M, Evangelou E, Caulfield M, Grodzicki T, D'Aiuto F, Guzik TJ. Causal association between periodontitis and hypertension: evidence from Mendelian randomization and a randomized controlled trial of non-surgical periodontal therapy. Eur Heart J. 2019 Nov 1;40(42):3459-3470. doi: 10.1093/eurheartj/ehz646.