Periodontal Management in Hypertensive Patients (PERIOTENSION Trial I)

NCT ID: NCT04328389

Last Updated: 2021-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontal Diseases Gingivitis Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Placebo Comparator: electric toothbrush

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

Group Type PLACEBO_COMPARATOR

electric toothbrush

Intervention Type BEHAVIORAL

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

Professional oral hygiene

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

Group Type EXPERIMENTAL

Professional oral hygiene

Intervention Type PROCEDURE

Professional oral hygiene using ultrosound scaling and root planing

Interventions

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electric toothbrush

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

Intervention Type BEHAVIORAL

Professional oral hygiene

Professional oral hygiene using ultrosound scaling and root planing

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of L'Aquila

OTHER

Sponsor Role lead

Responsible Party

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Davide Pietropaoli

junior researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rita Del Pinto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of L'Aquila Unit of Internal Medicine and Nephrology - Center for Hypertension

Davide Pietropaoli, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of L'Aquila - Unit of Oral Diseases

Central Contacts

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Davide Pietropaoli, DDS, PhD

Role: CONTACT

+39 0862 434974

Rita Del Pinto, MD. PhD

Role: CONTACT

References

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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.

Reference Type BACKGROUND
PMID: 30540406 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31090063 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31680283 (View on PubMed)

Other Identifiers

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AQ2020

Identifier Type: -

Identifier Source: org_study_id

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