Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I) (PERIOTENSION)

April 27, 2021 updated by: Davide Pietropaoli, University of L'Aquila

Periodontal Management in Hypertensive Patients

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Comparator: electric toothbrush
Participats will be instructed to used electric toothbrush for home supragingival plaque removal
Participants will be instructed to use their electric toothbrushes twice a day for controlling oral plaque
Experimental: Professional oral hygiene
Full-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session.
Professional oral hygiene using ultrosound scaling and root planing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and Diastolic Blood Pressure Change
Time Frame: 1 week
Ambulatory Blood Pressure Monitoring
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic and Diastolic Blood Pressure Change
Time Frame: 1 week
Unattented Blood Pressure Measurement
1 week

Other Outcome Measures

Outcome Measure
Time Frame
Periodontal Health Score - Bleeding on probing (BoP)
Time Frame: 1 week
1 week
Periodontal Health Score - Periodontal Probing Depth (PPD)
Time Frame: 1 week
1 week
Periodontal Health Score - Clinical Attachment Loss (CAL)
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rita Del Pinto, MD, PhD, University of L'Aquila Unit of Internal Medicine and Nephrology - Center for Hypertension
  • Principal Investigator: Davide Pietropaoli, DDS, PhD, University of L'Aquila - Unit of Oral Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2024

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 27, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

April 28, 2021

Last Update Submitted That Met QC Criteria

April 27, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • AQ2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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