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Trial registered on ANZCTR


Registration number
ACTRN12614001259639
Ethics application status
Approved
Date submitted
18/09/2014
Date registered
2/12/2014
Date last updated
2/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of Chlorhexidine in reducing oral colonization in geriatric patients: A Randomized Controlled Trial
Scientific title
The effect of Chlorhexidine in reducing oral colonization in geriatric patients: A Randomized Controlled Trial
Secondary ID [1] 285316 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral hygiene 293030 0
Condition category
Condition code
Oral and Gastrointestinal 293300 293300 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral care by nurses using 0.2% chlorhexidine mouthwash for 7 days, once daily with 20 ml per procedure. Oral Health Assessment of Older Adults : The Kayser-Jones brief oral health Status Examination (BOHSE) was used to monitor adherence to the intervention.
Intervention code [1] 290228 0
Prevention
Intervention code [2] 290697 0
Treatment: Drugs
Comparator / control treatment
Oral care by nurses using thymol gargle for 7 days, once daily with 20 ml per procedure. The ingredients inside thymol gargle includes purified water, glycerine, alcohol denat, tween 80, sodium bicarbonate, sodium salicylate, methylpraben, eucalyptus globulus leaf oil, pinus palustris oil, sodium benzoate, thymol, menthol, methyl salicylate, acid red 14, caramel and sodium metabusulfate.

Oral Health Assessment of Older Adults : The Kayser-Jones brief oral health Status Examination (BOHSE) was used to monitor adherence to the intervention.
Control group
Active

Outcomes
Primary outcome [1] 293138 0
Oral health condition using Kayser-Jones brief oral health status examination (BOHSE)
Timepoint [1] 293138 0
Baseline before giving oral care, and at the end of intervention (day 7)
Primary outcome [2] 293139 0
Oral colonization by taking oral swab for culture
Timepoint [2] 293139 0
Baseline before giving oral care, and at the end of intervention (day 7)
Secondary outcome [1] 310436 0
Incidence rate of aspiration pneumonia was assessed by using oral swab. Sample for viable count analysis were collected from buccal and dorsum of the tongue using sterile orange stick. The sample were transferred to transport medium and process within 24 hours.
Timepoint [1] 310436 0
Baseline before giving oral care, and at the end of intervention (day 7)

Eligibility
Key inclusion criteria
Patients admitted to the geriatric ward in University Malaya Medical Center (UMMC), aged 65 years old and above, edentulous with or without dentures and those with functional impairment.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have current oral infections or a diagnosis of pneumonia during admission. They also were not on antibiotics for at least two weeks before enrolling into the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The researcher conducted daily screening of all eligible geriatric patients admitted to the ward during the study period. A total of 90 subjects who fulfilled the criteria were recruited. After informed consent was obtained and family members or caregivers were notified, patients were randomized by block randomization (1:1) and random number table placed in one of the two arms. The intervention group received oral care with chlorhexidine while the control group received routine oral care with thymol.
Both solutions were provided by hospital pharmacy. In order to maintain concealment of treatment, both solutions were similar in appearance in terms of bottle type and size, its amount, and color. They were labeled as A or B as a code key (A for Chlorhexidine and B for thymol gargle).
The nurses who performed oral care procedure were blinded to the code key. This is a double blind study where the patients, nurses, and medical laboratory technicians were not exposed to the code key.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The researcher developed a list of numbers from 1 to 300; from there total 90 samples were randomly chosen through a random number table which was generated by Stattrek Random Number Generator. Participants with number from column one received bottle 'A' consisting of chlorhexidine mouthwash while participants with numbers from column two received bottle 'B' consisting of thymol gargle.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size for the study was calculated using the formula by Sakpal (2010). The mean difference 0.5 with standard deviation of 0.71 was calculated based on the results of previous studies done by Clavero, Baca, Junco, & Paloma (2003). In order to reduce the risk of committing type II error due to insufficient sample size and statistical power, the researcher fixed the power at 0.80 and alpha value of 0.05. To anticipate the potential attritions of subjects during the course of study, additional 10% of the samples were recruited. Thus, the total sample size was 90 (45 in each group).
Demographic, clinical and microbiology data was examined using Chi Square and Independent t-test. Chi Square was used to examine the effectiveness of chlorhexidine. Repeated measured ANOVA was used to test the oral health condition in both groups. The statistical significant was set at 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2013
Actual
1/01/2013
Date of last participant enrolment
Anticipated
25/03/2013
Actual
25/03/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment outside Australia
Country [1] 6348 0
Malaysia
State/province [1] 6348 0
Kuala Lumpur

Funding & Sponsors
Funding source category [1] 289939 0
University
Name [1] 289939 0
University of Malaya Postgraduate Research Fund
Country [1] 289939 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 288628 0
None
Name [1] 288628 0
Address [1] 288628 0
Country [1] 288628 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
A double blinded parallel randomized controlled trial was carried out. The intervention group received oral care with chlorhexidine whereas the control group received routine oral care (with thymol). Oral care was performed by nurses with assigned solutions once daily with 20 ml assigned solution per procedure for 7 days. Oral cavity assessment using Brief Oral Health Status Examination (BOHSE) form was performed before procedure day 1 to day 7. Data on medication received and the development of aspiration pneumonia was taken. Specimen for oral swab for colonization was taken on day 7.
The final sample consisted of 35 (control) and 42 patients (intervention) subjects. CHX was effective in reducing oral colonization compared to routine oral care with thymol (p<0.001).Thymol group had nearly 3 times higher risk of oral bacterial colonization compared to the CHX group.
Trial website
Trial related presentations / publications
Not applicable
Public notes

Contacts
Principal investigator
Name 51330 0
Ms Sharifah Shafinaz Binti Sharif Abdullah
Address 51330 0
a) Department of Nursing Science
Faculty of Medicine
University of Malaya,
50603 Kuala Lumpur, Malaysia.

b) University Institute Technology Mara,
40450 Shah Alam, Selangor
Malaysia
Country 51330 0
Malaysia
Phone 51330 0
+6013285116
Fax 51330 0
Email 51330 0
[email protected]
Contact person for public queries
Name 51331 0
Ms Sharifah Shafinaz Binti Sharif Abdullah
Address 51331 0
a) Department of Nursing Science
Faculty of Medicine
University of Malaya,
50603 Kuala Lumpur, Malaysia.

b) University Institute Technology Mara,
40450 Shah Alam, Selangor
Malaysia
Country 51331 0
Malaysia
Phone 51331 0
+6013285116
Fax 51331 0
Email 51331 0
[email protected]
Contact person for scientific queries
Name 51332 0
Dr Chong Mei Chan
Address 51332 0
Department of Nursing Science
Faculty of Medicine
University of Malaya,
50603 Kuala Lumpur, Malaysia.
Country 51332 0
Malaysia
Phone 51332 0
+ 6037949 3675
Fax 51332 0
Email 51332 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe effect of chlorhexidine in reducing oral colonisation in geriatric patients: A randomised controlled trial.2016https://dx.doi.org/10.11622/smedj.2016091
N.B. These documents automatically identified may not have been verified by the study sponsor.