NCT01477099

Brief Summary

The hypothesis is that adding the toothbrushing to the oral care with clorhexidine 0.12% could be reduce the incidence of ventilator-associated pneumonia due to that oral cavity may be an important reservoir of pathogens that could cause pneumonia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
436

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

August 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
Last Updated

November 22, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

November 16, 2011

Last Update Submit

November 18, 2011

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Prevention of ventilator-associated pneumonia

    60 days

Study Arms (2)

Toothbrushing with a manual brush

EXPERIMENTAL

Toothbrushing with a manual brush

Device: Toothbrushing with a manual brush

No toothbrushing

NO INTERVENTION

no toothbrushing

Interventions

Toothbrushing with a manual brushDEVICE

Toothbrushing with a manual brush

Toothbrushing with a manual brush

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mechanical ventilation

You may not qualify if:

  • edentulous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leonardo Lorente

San Cristóbal de La Laguna, Tenerife, 38320, Spain

Location

Related Publications (1)

  • Lorente L, Lecuona M, Jimenez A, Palmero S, Pastor E, Lafuente N, Ramos MJ, Mora ML, Sierra A. Ventilator-associated pneumonia with or without toothbrushing: a randomized controlled trial. Eur J Clin Microbiol Infect Dis. 2012 Oct;31(10):2621-9. doi: 10.1007/s10096-012-1605-y. Epub 2012 Mar 16.

    PMID: 22422274DERIVED

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Officials

  • Leonardo Lorente, Medical

    Hospital Universitario de Canarias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 16, 2011

First Posted

November 22, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 22, 2011

Record last verified: 2011-11

Locations

ES(1)