Clinical trial NCT01265043: A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke
Official title: A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Stroke
Keywords: oral health
oral hygiene
bacteria
quality of life
Clinical oral health in patients following acute stroke
Oral opportunistic pathogens in patients following acute stroke
Oral health-related quality of life in patients following acute stroke
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2010-12-22
Enrollment: 102
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of this oral health intervention project is to compare the effect of providing 1) professional oral hygiene instruction alone versus 2) professional oral hygiene instruction plus adjunctive Chlorhexidine mouth rinse versus 3) professional oral hygiene instruction plus adjunctive assisted tooth brushing and Chlorhexidine mouth rinse, on the oral health condition, the general health condition and health-related quality of life (HRQoL) of patients with stroke who are receiving hospital-based rehabilitation. An additional aim is to assess potential longer term oral intervention-related health and HRQoL outcomes.


Eligibility criteria: Inclusion Criteria:

* Aged 50 years and over
* Moderate to severe stroke (Barthel Index \>/= 70)
* Admitted to Rehabilitation Unit within 7 days

Exclusion Criteria:

* Patients with naso-gastric feeding tube
* Edentulous patients
* Patients with communication difficulties

Primary outcomes:
measure: Change in plaque scores over course of trial
timeFrame: Three week in-hospital rehabilitation period
Secondary outcomes:
measure: Change in gingival bleeding scores over course of trial
timeFrame: three week in-hospital rehabilitation period
measure: Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial
timeFrame: Three week in-hospital rehabilitation period
measure: Change in oral colonization by Staphylococcus aureus over course of trial
timeFrame: Three week in-hospital rehabilitation period
measure: Change in oral colonization by yeasts over course of trial
timeFrame: Three week in-hospital rehabilitation period
measure: Change in health-related quality of life over course of trial
timeFrame: three week in-hospital rehabilitation period
measure: Change in oral health-related quality of life over course of trial
timeFrame: Three week in-hospital rehabilitation period
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Tung Wah Hospital
Study officials:
affiliation: The University of Hong Kong
name: Otto LT Lam, BDS, BSc, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam OL, McMillan AS, Samaranayake LP, Li LS, McGrath C. Effect of oral hygiene interventions on opportunistic pathogens in patients after stroke. Am J Infect Control. 2013 Feb;41(2):149-54. doi: 10.1016/j.ajic.2012.02.020. Epub 2012 Jul 17.