NCT04328389

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 31, 2020

Completed
4.2 years until next milestone

Study Start

First participant enrolled

June 1, 2024

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

March 27, 2020

Last Update Submit

April 27, 2021

Conditions

Periodontal DiseasesGingivitisHypertension

Outcome Measures

Primary Outcomes (1)

  • Systolic and Diastolic Blood Pressure Change

    Ambulatory Blood Pressure Monitoring

    1 week

Secondary Outcomes (1)

  • Systolic and Diastolic Blood Pressure Change

    1 week

Other Outcomes (3)

  • Periodontal Health Score - Bleeding on probing (BoP)

    1 week

  • Periodontal Health Score - Periodontal Probing Depth (PPD)

    1 week

  • Periodontal Health Score - Clinical Attachment Loss (CAL)

    1 week

Study Arms (2)

Placebo Comparator: electric toothbrush

PLACEBO COMPARATOR

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

Behavioral: electric toothbrush

Professional oral hygiene

EXPERIMENTAL

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

Procedure: Professional oral hygiene

Interventions

electric toothbrushBEHAVIORAL

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

Placebo Comparator: electric toothbrush
Professional oral hygienePROCEDURE

Professional oral hygiene using ultrosound scaling and root planing

Professional oral hygiene

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Treated hypertension
  • Have at least 20 natural teeth
  • Presence of any form of periodontal diseases according to guidelines
  • Absence of other significant oral infections.

You may not qualify if:

  • 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
  • History of alcohol abuse or unwillingness to limit alcohol consumption to less than 4 drinks per week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 30540406BACKGROUND

  • 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.

    PMID: 31090063BACKGROUND

  • 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.

    PMID: 31680283BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesGingivitisHypertension

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Davide Pietropaoli, DDS, PhD

CONTACT

+39 0862 434974davide.pietropaoli@univaq.it

Rita Del Pinto, MD. PhD

CONTACT

rita.delpinto@univaq.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
junior researcher

Study Record Dates

First Submitted

March 27, 2020

First Posted

March 31, 2020

Study Start

June 1, 2024

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

April 28, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share