Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

Hypertension Clinical Trial

— PERIOTENSION  

Official title:

Periodontal Management in Hypertensive Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04328389
• Other study ID #: AQ2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2024

Study information

• Verified date: April 2021
• Source: University of L'Aquila
• Contact: Davide Pietropaoli, DDS, PhD
• Phone: +39 0862 434974
• Email: davide.pietropaoli[@]univaq.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Gingivitis
• Hypertension
• Periodontal Diseases

Intervention

Behavioral:
• electric toothbrush
Participants will be instructed to use their electric toothbrushes twice a day for controlling oral plaque

Procedure:
• Professional oral hygiene
Professional oral hygiene using ultrosound scaling and root planing

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of L'Aquila

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Periodontal Health Score - Bleeding on probing (BoP)		1 week
Other	Periodontal Health Score - Periodontal Probing Depth (PPD)		1 week
Other	Periodontal Health Score - Clinical Attachment Loss (CAL)		1 week
Primary	Systolic and Diastolic Blood Pressure Change	Ambulatory Blood Pressure Monitoring	1 week
Secondary	Systolic and Diastolic Blood Pressure Change	Unattented Blood Pressure Measurement	1 week