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Completed

NCT Number: NCT01265043

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

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.

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Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tung Wah Hospital

Hong Kong

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oral hygiene intervention

Other

Oral health promotion intervention

Primary outcomes

  1. Change in plaque scores over course of trial

    Time frame: Three week in-hospital rehabilitation period

Secondary outcomes

  1. Change in gingival bleeding scores over course of trial

    Time frame: three week in-hospital rehabilitation period

  2. Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial

    Time frame: Three week in-hospital rehabilitation period

  3. Change in oral colonization by Staphylococcus aureus over course of trial

    Time frame: Three week in-hospital rehabilitation period

  4. Change in oral colonization by yeasts over course of trial

    Time frame: Three week in-hospital rehabilitation period

  5. Change in health-related quality of life over course of trial

    Time frame: three week in-hospital rehabilitation period

  6. Change in oral health-related quality of life over course of trial

    Time frame: Three week in-hospital rehabilitation period

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 22, 2010
Registry last updated
Oct 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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