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

Primary Purpose

Periodontal Diseases, Gingivitis, Hypertension

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
electric toothbrush
Professional oral hygiene
Sponsored by
University of L'Aquila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Placebo Comparator: electric toothbrush

    Professional oral hygiene

    Arm Description

    Participats will be instructed to used electric toothbrush for home supragingival plaque removal

    Full-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session.

    Outcomes

    Primary Outcome Measures

    Systolic and Diastolic Blood Pressure Change
    Ambulatory Blood Pressure Monitoring

    Secondary Outcome Measures

    Systolic and Diastolic Blood Pressure Change
    Unattented Blood Pressure Measurement

    Full Information

    First Posted
    March 27, 2020
    Last Updated
    April 27, 2021
    Sponsor
    University of L'Aquila
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04328389
    Brief Title
    Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)
    Acronym
    PERIOTENSION
    Official Title
    Periodontal Management in Hypertensive Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2024 (Anticipated)
    Primary Completion Date
    June 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of L'Aquila

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periodontal Diseases, Gingivitis, Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Placebo Comparator: electric toothbrush
    Arm Type
    Placebo Comparator
    Arm Description
    Participats will be instructed to used electric toothbrush for home supragingival plaque removal
    Arm Title
    Professional oral hygiene
    Arm Type
    Experimental
    Arm Description
    Full-Mouth professional oral hygiene consisting in scaling and root planing, four quadrants in one session.
    Intervention Type
    Behavioral
    Intervention Name(s)
    electric toothbrush
    Intervention Description
    Participants will be instructed to use their electric toothbrushes twice a day for controlling oral plaque
    Intervention Type
    Procedure
    Intervention Name(s)
    Professional oral hygiene
    Intervention Description
    Professional oral hygiene using ultrosound scaling and root planing
    Primary Outcome Measure Information:
    Title
    Systolic and Diastolic Blood Pressure Change
    Description
    Ambulatory Blood Pressure Monitoring
    Time Frame
    1 week
    Secondary Outcome Measure Information:
    Title
    Systolic and Diastolic Blood Pressure Change
    Description
    Unattented Blood Pressure Measurement
    Time Frame
    1 week
    Other Pre-specified Outcome Measures:
    Title
    Periodontal Health Score - Bleeding on probing (BoP)
    Time Frame
    1 week
    Title
    Periodontal Health Score - Periodontal Probing Depth (PPD)
    Time Frame
    1 week
    Title
    Periodontal Health Score - Clinical Attachment Loss (CAL)
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Davide Pietropaoli, DDS, PhD
    Phone
    +39 0862 434974
    Email
    davide.pietropaoli@univaq.it
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rita Del Pinto, MD. PhD
    Email
    rita.delpinto@univaq.it
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rita Del Pinto, MD, PhD
    Organizational Affiliation
    University of L'Aquila Unit of Internal Medicine and Nephrology - Center for Hypertension
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Davide Pietropaoli, DDS, PhD
    Organizational Affiliation
    University of L'Aquila - Unit of Oral Diseases
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30540406
    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.
    Results Reference
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    PubMed Identifier
    31090063
    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.
    Results Reference
    background
    PubMed Identifier
    31680283
    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.
    Results Reference
    background

    Learn more about this trial

    Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

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