AzTrials
AzTrials

Ventilator Associated PneumoniaNCT02288390

Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush.

A study testing Oral care in mechanically ventilated patients in people with Ventilator Associated Pneumonia, run by University of Alexandria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 2 to 70 years
Conditions the study is for
Ventilator Associated Pneumonia
What is being tested?
Oral care in mechanically ventilated patients
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Jul 2007to Sep 2008
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Mechanically ventilated

Who cannot join

  • None

About this study

Official title: Oral Care as a Preventive Measure of VAP; Miswak Versus Chlorhexidine and Toothbrush, a Prospective, Randomized Controlled Study

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

Read the detailed description

The selected patients were randomized into 2 groups by the conventional method of randomization. For each patient the following parameters were collected: patient data; age, gender; history of smoking; chronic health problems; history of drugs as steroids, chemotherapy, current antimicrobial therapy; and the primary cause of hospital and ICU admission and mechanical ventilation.

Clinical examination included assessment of disease severity on admission by Acute Physiology and Chronic Health Evaluation (APACHE II) scoring system, oral and dental examination, and dental plaque score calculation. Oropharyngeal and dental swabs were collected on admission.

The preventative VAP bundle was applied to all patients in both groups. For group I, Miswak was used for oral care, patient's teeth were brushed every 4 hours using a Miswak stick after scraping of half an inch bark from the stick end then Miswak tip was washed and compressed to make it brush like. Both buccal and lingual surfaces of teeth were brushed using mechanical method for plaque removal (in direction away from gingival margin,). The patient's tongue was brushed when possible and lip moisturizer was applied as needed. The brush like end of sewak stick was cut and replaced daily.

For group II, the patient's teeth were brushed every 4 hours using a soft toothbrush with 0.12% Chlorhexidine solution. Both buccal and lingual surfaces of teeth were brushed using mechanical method for plaque removal (in direction away from gingival margin,). The patient's tongue was brushed when possible and lip moisturizer was applied as needed. The toothbrush was boiled for one minute every day.

Patients in both groups were monitored for the efficacy of oral care in term of plaque score and halitosis. Colonization of trachea, OPH, and dental plaque by potential respiratory pathogens (PRPs) as Staphylococcus aureus, Pseudomonas, Klebsiella, Proteus, Acinetobacter and E. coli species was identified by culturing of OPH swab, dental swab and endotracheal tube (ETT) aspirate on inclusion into the study and every 4 days thereafter till ICU discharge, 3 weeks of ICU stay, or death. Secondary endpoints included time to VAP and its incidence, duration of MV, ICU discharge, and mortality rate.

VAP was diagnosed when patient developed; new and/or progressive infiltrates in chest radiograph plus two or more of the following; leucocytosis ≥ 12000/mm3 or leucopenia ≤ 4000c/mm3, fever > 38oC or hypothermia < 36oC, or mucopurulent secretion as evident by gross inspection. The clinically diagnosed VAP was confirmed by quantitative endotracheal aspirate at a cut off value ≥105 colony forming unit (cfu) /ml.

Being tested
Oral care in mechanically ventilated patients
Keywords
VAP, Oral care, Chlorhexidine, Miswak (Sewak)
Medical subject headings
Pneumonia, Ventilator-Associated

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral care in mechanically ventilated patientsProcedure or surgery

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

Study groups in NCT02288390
Study groupRoleWhat they receive
Miswak (Sewak)Active comparatorMiswak (sewak) oral care applied 4 hourly for oral care in mechanically ventilated patients.
Receives: Procedure: Oral care in mechanically ventilated patients
Chlorhexidine/ toothbrushActive comparatorChlorhexidine 0.12 % plus toothbrushing oral care applied 4 hourly for oral care in mechanically ventilated patients.
Receives: Procedure: Oral care in mechanically ventilated patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dental plaque score - oropharyngeal colonization

    Measured: 21 days

Secondary outcomes (3)
  1. ventilator associated pneumonia

    Measured: 21 days

  2. Mortality

    Measured: 21 days

  3. duration of mechanical ventilation and ICU stay

    Measured: 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2014 (estimated)
  2. Study startJul 2007
  3. Primary completionMay 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02288390
Sponsor's protocol ID
Faculty of Medicine 10.07.2007
Status last verified
Nov 2014
First submitted
31 Oct 2014
Last updated
11 Nov 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Oral care in mechanically ventilated patients in people with Ventilator Associated Pneumonia, run by University of Alexandria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dental plaque score - oropharyngeal colonization (time frame: 21 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2014.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in