NCT01265043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 22, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

December 7, 2010

Last Update Submit

October 2, 2021

Conditions

Acute Stroke

Keywords

oral healthoral hygienebacteriaquality of lifeClinical oral health in patients following acute strokeOral opportunistic pathogens in patients following acute strokeOral health-related quality of life in patients following acute stroke

Outcome Measures

Primary Outcomes (1)

  • Change in plaque scores over course of trial

    Three week in-hospital rehabilitation period

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

OHI

EXPERIMENTAL

Patients provided with oral hygiene instruction and electric toothbrush

Other: Oral hygiene intervention

OHI + CHX mouthrinse

EXPERIMENTAL

Patients provided with oral hygiene instruction and Corsodyl mouthrinse

Other: Oral hygiene intervention

OHI + CHX mouthrinse + assisted brushing

EXPERIMENTAL

Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing

Other: Oral hygiene intervention

Interventions

Oral hygiene interventionOTHER

Oral health promotion intervention

OHIOHI + CHX mouthrinseOHI + CHX mouthrinse + assisted brushing

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tung Wah Hospital

Hong Kong, Hong Kong

Location

Related Publications (1)

  • 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.

    PMID: 22818804DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Otto LT Lam, BDS, BSc, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical assistant professor

Study Record Dates

First Submitted

December 7, 2010

First Posted

December 22, 2010

Study Start

July 1, 2008

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

October 8, 2021

Record last verified: 2021-10

Locations

HK(1)