Acute StrokePhase 4NCT01265043
A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients After Stroke
A Phase 4 study testing Oral hygiene intervention in people with Acute Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Acute Stroke
- What is being tested?
- Oral hygiene intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteHong Kong
- Study dates
- Jul 2008to May 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 50 years and over
- Moderate to severe stroke (Barthel Index >/= 70)
- Admitted to Rehabilitation Unit within 7 days
Who cannot join
- Patients with naso-gastric feeding tube
- Edentulous patients
- Patients with communication difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following 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.
- Conditions
- Acute Stroke
- Being tested
- Oral hygiene intervention
- Keywords
- 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
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene interventionOther
Oral health promotion intervention
| Study group | Role | What they receive |
|---|---|---|
| OHI | Experimental | Patients provided with oral hygiene instruction and electric toothbrush Receives: Other: Oral hygiene intervention |
| OHI + CHX mouthrinse | Experimental | Patients provided with oral hygiene instruction and Corsodyl mouthrinse Receives: Other: Oral hygiene intervention |
| OHI + CHX mouthrinse + assisted brushing | Experimental | Oral hygiene instruction, Corsodyl mouthrinse, and assisted brushing Receives: Other: Oral hygiene intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plaque scores over course of trial
Measured: Three week in-hospital rehabilitation period
Secondary outcomes (6)
Change in gingival bleeding scores over course of trial
Measured: three week in-hospital rehabilitation period
Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial
Measured: Three week in-hospital rehabilitation period
Change in oral colonization by Staphylococcus aureus over course of trial
Measured: Three week in-hospital rehabilitation period
Change in oral colonization by yeasts over course of trial
Measured: Three week in-hospital rehabilitation period
Change in health-related quality of life over course of trial
Measured: three week in-hospital rehabilitation period
Change in oral health-related quality of life over course of trial
Measured: Three week in-hospital rehabilitation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2010 (estimated)
- Study startJul 2008
- Primary completionMay 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Otto Lok-Tao Lam, The University of Hong Kong
- Investigators
- Otto LT Lam, BDS, BSc, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265043
- Sponsor's protocol ID
- HKCTR-1159
- Status last verified
- Oct 2021
- First submitted
- 7 Dec 2010
- Last updated
- 8 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22818804
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke
- ClinicalTrials.gov ID
- NCT01265043
- Acronym / sponsor ID
- HKCTR-1159
- Conditions
- Acute Stroke
- Keywords
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 22 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OHI | Experimental | Other: Oral hygiene interventionPatients provided with oral hygiene instruction and electric toothbrush |
| OHI + CHX mouthrinse | Experimental | Other: Oral hygiene interventionPatients provided with oral hygiene instruction and Corsodyl mouthrinse |
| OHI + CHX mouthrinse + assisted brushing | Experimental | Other: Oral hygiene interventionOral hygiene instruction, Corsodyl mouthrinse, and assisted brushing |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 50 years and over
- Moderate to severe stroke (Barthel Index >/= 70)
- Admitted to Rehabilitation Unit within 7 days
Key exclusion criteria (3 listed)
- Patients with naso-gastric feeding tube
- Edentulous patients
- Patients with communication difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral hygiene interventionOral health promotion intervention | Other | OHI, OHI + CHX mouthrinse, OHI + CHX mouthrinse + assisted brushing |
Primary outcome
Change in plaque scores over course of trial
Time frame: Three week in-hospital rehabilitation period
6 secondary outcomes
Change in gingival bleeding scores over course of trial
Time frame: three week in-hospital rehabilitation period
Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial
Time frame: Three week in-hospital rehabilitation period
Change in oral colonization by Staphylococcus aureus over course of trial
Time frame: Three week in-hospital rehabilitation period
Change in oral colonization by yeasts over course of trial
Time frame: Three week in-hospital rehabilitation period
Change in health-related quality of life over course of trial
Time frame: three week in-hospital rehabilitation period
Change in oral health-related quality of life over course of trial
Time frame: Three week in-hospital rehabilitation period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Derived from this study: PubMed 22818804Lam 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Otto LT Lam, BDS, BSc, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral hygiene intervention in people with Acute Stroke, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in plaque scores over course of trial (time frame: Three week in-hospital rehabilitation period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01265043, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.