A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke

Conditions
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Acute Stroke

Intervention / Treatment
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* Other: Oral hygiene intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OHI<br>Patients provided with oral hygiene instruction and electric toothbrush | Other: Oral hygiene intervention<br>* Oral health promotion intervention<br>|
| Experimental: OHI + CHX mouthrinse<br>Patients provided with oral hygiene instruction and Corsodyl mouthrinse | Other: Oral hygiene intervention<br>* Oral health promotion intervention<br>|
| Experimental: OHI + CHX mouthrinse + assisted brushing<br>Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing | Other: Oral hygiene intervention<br>* Oral health promotion intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plaque scores over course of trial |  | Three week in-hospital rehabilitation period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gingival bleeding scores over course of trial |  | three week in-hospital rehabilitation period | 
| Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial |  | Three week in-hospital rehabilitation period | 
| Change in oral colonization by Staphylococcus aureus over course of trial |  | Three week in-hospital rehabilitation period | 
| Change in oral colonization by yeasts over course of trial |  | Three week in-hospital rehabilitation period | 
| Change in health-related quality of life over course of trial |  | three week in-hospital rehabilitation period | 
| Change in oral health-related quality of life over course of trial |  | Three week in-hospital rehabilitation period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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