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A Clinical Trial on the Effect of Chlorhexidine Mouth Rinse and Assisted Tooth Brushing on the Health Condition and Quality of Life of Elderly Stroke Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by The University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01265043
First received: December 7, 2010
Last updated: December 21, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Acute Stroke
 Other: Oral hygiene intervention
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Dental Health
U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Change in plaque scores over course of trial [ Time Frame: Three week in-hospital rehabilitation period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in gingival bleeding scores over course of trial [ Time Frame: three week in-hospital rehabilitation period ] [ Designated as safety issue: No ]
  • Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial [ Time Frame: Three week in-hospital rehabilitation period ] [ Designated as safety issue: No ]
  • Change in oral colonization by Staphylococcus aureus over course of trial [ Time Frame: Three week in-hospital rehabilitation period ] [ Designated as safety issue: No ]
  • Change in oral colonization by yeasts over course of trial [ Time Frame: Three week in-hospital rehabilitation period ] [ Designated as safety issue: No ]
  • Change in health-related quality of life over course of trial [ Time Frame: three week in-hospital rehabilitation period ] [ Designated as safety issue: No ]
  • Change in oral health-related quality of life over course of trial [ Time Frame: Three week in-hospital rehabilitation period ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OHI
Patients provided with oral hygiene instruction and electric toothbrush
 Other: Oral hygiene intervention
Oral health promotion intervention
Experimental: OHI + CHX mouthrinse
Patients provided with oral hygiene instruction and Corsodyl mouthrinse
 Other: Oral hygiene intervention
Oral health promotion intervention
Experimental: OHI + CHX mouthrinse + assisted brushing
Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing
 Other: Oral hygiene intervention
Oral health promotion intervention

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265043

Contacts
Contact: Otto LT Lam, BDS, BSc 60762272 ottolam_1@yahoo.ca
Contact: Colman PJ McGrath, PhD 28590513 mcgrathc@hkucc.hku.hk

Locations
Hong Kong
Tung Wah Hospital Recruiting
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
  More Information

No publications provided by The University of Hong Kong

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Colman McGrath/Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01265043     History of Changes
Other Study ID Numbers: HKCTR-1159
Study First Received: December 7, 2010
Last Updated: December 21, 2010
Health Authority: Hong Kong: Institutional Review Board

Keywords provided by The University of Hong Kong:
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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 22, 2013