Clinical trial NCT04328389: Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)
Official title: Periodontal Management in Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Diseases
Gingivitis
Hypertension
Lead sponsor: University of L'Aquila
Sponsor class: OTHER
First posted: 2020-03-31
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treated hypertensive patients with any form of periodontal diseases will be randomized to either supragingival dental plaque removal using electric toothbrushes at home or intensive professional oral hygiene treatment and the effects on blood pressure will be identified.


Eligibility criteria: Inclusion Criteria:

* Treated hypertension
* Have at least 20 natural teeth
* Presence of any form of periodontal diseases according to guidelines
* Absence of other significant oral infections.

Exclusion Criteria:

* Secondary hypertension (known plasma renin screening, abdominal ultrasound with doppler and other investigations)
* Individual is pregnant or nursing
* Primary pulmonary hypertension
* Professional oral hygine within past 6 months
* Flu, rhinitis, sinusitis etc. within past 4 weeks
* Use of antibiotics within past 4 weeks
* Hospitalization for any reason within the past 3 months
* Allergic disorders; History of chronic infectious disease,
* Chronic hepatitis B or C infection
* Chronic Obstructive Pulmonary Disease (COPD), tuberculosis
* Other known chronic inflammatory or autoimmune condition such as lupus or rheumatoid arthritis, ulcerative colitis or Crohn's disease
* Use of systemic or local steroids or immunosuppressive agents within 6 months of the inclusion.
* History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week

Primary outcomes:
measure: Systolic and Diastolic Blood Pressure Change
timeFrame: 1 week
Secondary outcomes:
measure: Systolic and Diastolic Blood Pressure Change
timeFrame: 1 week
Other outcomes:
measure: Periodontal Health Score - Bleeding on probing (BoP)
timeFrame: 1 week
measure: Periodontal Health Score - Periodontal Probing Depth (PPD)
timeFrame: 1 week
measure: Periodontal Health Score - Clinical Attachment Loss (CAL)
timeFrame: 1 week
Locations:
Study officials:
affiliation: University of L'Aquila Unit of Internal Medicine and Nephrology - Center for Hypertension
name: Rita Del Pinto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of L'Aquila - Unit of Oral Diseases
name: Davide Pietropaoli, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pietropaoli D, Del Pinto R, Ferri C, Wright JT Jr, Giannoni M, Ortu E, Monaco A. Poor Oral Health and Blood Pressure Control Among US Hypertensive Adults. Hypertension. 2018 Dec;72(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.118.11528.
citation: Pietropaoli D, Del Pinto R, Ferri C, Ortu E, Monaco A. Definition of hypertension-associated oral pathogens in NHANES. J Periodontol. 2019 Aug;90(8):866-876. doi: 10.1002/JPER.19-0046. Epub 2019 May 29.
citation: Pietropaoli D, Del Pinto R, Ferri C, Marzo G, Giannoni M, Ortu E, Monaco A. Association between periodontal inflammation and hypertension using periodontal inflamed surface area and bleeding on probing. J Clin Periodontol. 2020 Feb;47(2):160-172. doi: 10.1111/jcpe.13216. Epub 2019 Nov 26.