NCT02288390

Brief Summary

Dental plaque score calculation and swabs of Oropharynx and teeth were collected on admission. For group I, Miswak stick was used 4 hourly for oral care. For group II, 0.12% Chlorhexidine/ toothbrush were used 4 hourly

Trial Health

100
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

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

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
Last Updated

November 11, 2014

Status Verified

November 1, 2014

Enrollment Period

10 months

First QC Date

October 31, 2014

Last Update Submit

November 10, 2014

Conditions

Ventilator Associated Pneumonia

Keywords

VAPOral careChlorhexidineMiswak (Sewak)

Outcome Measures

Primary Outcomes (1)

  • Dental plaque score - oropharyngeal colonization

    21 days

Secondary Outcomes (3)

  • ventilator associated pneumonia

    21 days

  • Mortality

    21 days

  • duration of mechanical ventilation and ICU stay

    21 days

Study Arms (2)

Miswak (Sewak)

ACTIVE COMPARATOR

Miswak (sewak) oral care applied 4 hourly for oral care in mechanically ventilated patients.

Procedure: Oral care in mechanically ventilated patients

Chlorhexidine/ toothbrush

ACTIVE COMPARATOR

Chlorhexidine 0.12 % plus toothbrushing oral care applied 4 hourly for oral care in mechanically ventilated patients.

Procedure: Oral care in mechanically ventilated patients

Interventions

Oral care in mechanically ventilated patientsPROCEDURE

Oral care comparing Chlorhexidine and toothbrush versus Miswak ( the twig of Arak, Salvadora perscia, tree)

Chlorhexidine/ toothbrushMiswak (Sewak)

Eligibility Criteria

Age2 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mechanically ventilated

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Egypt, Alexandria, Sidi Gaber

Study Record Dates

First Submitted

October 31, 2014

First Posted

November 11, 2014

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

September 1, 2008

Last Updated

November 11, 2014

Record last verified: 2014-11