- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04328389
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
Status
Not yet recruiting
Conditions
Intervention / Treatment
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
- Name: Davide Pietropaoli, DDS, PhD
- Phone Number: +39 0862 434974
- Email: davide.pietropaoli@univaq.it
Study Contact Backup
- Name: Rita Del Pinto, MD. PhD
- Email: rita.delpinto@univaq.it
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.
Sponsor
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.
General Publications
- 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.
- 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.
- 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.
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
Additional Relevant MeSH Terms
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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