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

October 2, 2021 updated by: Dr. Otto Lok-Tao Lam, The University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Tung Wah Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in plaque scores over course of trial
Time Frame: Three week in-hospital rehabilitation period
Three week in-hospital rehabilitation period

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in gingival bleeding scores over course of trial
Time Frame: three week in-hospital rehabilitation period
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
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
Three week in-hospital rehabilitation period
Change in oral colonization by yeasts over course of trial
Time Frame: Three week in-hospital rehabilitation period
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
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
Three week in-hospital rehabilitation period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Investigators

  • Principal Investigator: Otto LT Lam, BDS, BSc, PhD, The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

May 1, 2011

Study Completion (ACTUAL)

May 1, 2011

Study Registration Dates

First Submitted

December 7, 2010

First Submitted That Met QC Criteria

December 21, 2010

First Posted (ESTIMATE)

December 22, 2010

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2021

Last Update Submitted That Met QC Criteria

October 2, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCTR-1159

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Stroke

Clinical Trials on Oral hygiene intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burkina Faso

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe