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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otto Lok Tao Lam, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01265043
First received: December 7, 2010
Last updated: June 9, 2015
Last verified: June 2015
  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
Official Title: A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke

Resource links provided by NLM:


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 ]

Enrollment: 102
Study Start Date: July 2008
Study Completion Date: May 2011
Primary Completion Date: May 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265043

Locations
Hong Kong
Tung Wah Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Otto LT Lam, BDS, BSc, PhD 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: Otto Lok Tao Lam, Clinical assistant 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: June 9, 2015
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:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 31, 2015