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

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT01265043
• Collaborator: (none)
• Enrollment: 102
• Location: 1
• Arms: 3
• Duration (Months): 34
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke	Other: Oral hygiene intervention	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 102 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Clinical Trial of Oral Health Promotion Interventions Among Patients Following Stroke
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Change in plaque scores over course of trial [Three week in-hospital rehabilitation period]

Secondary Outcome Measures

1. Change in gingival bleeding scores over course of trial [three week in-hospital rehabilitation period]

2. Change in oral colonization by aerobic and facultatively anaerobic Gram-negative bacilli over course of trial [Three week in-hospital rehabilitation period]

3. Change in oral colonization by Staphylococcus aureus over course of trial [Three week in-hospital rehabilitation period]

4. Change in oral colonization by yeasts over course of trial [Three week in-hospital rehabilitation period]

5. Change in health-related quality of life over course of trial [three week in-hospital rehabilitation period]

6. Change in oral health-related quality of life over course of trial [Three week in-hospital rehabilitation period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Otto Lok-Tao Lam, Clinical assistant professor, The University of Hong Kong
• ClinicalTrials.gov Identifier: NCT01265043
• Other Study ID Numbers: HKCTR-1159
• First Posted: Dec 22, 2010
• Last Update Posted: Oct 8, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Dr. Otto Lok-Tao Lam, Clinical assistant professor, 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

Study Results

No Results Posted as of Oct 8, 2021