Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist

Pneumonia Clinical Trial

Official title:

The Interventional Study in the Effects of Oral Care With Vaccines at Nursing Home; the Role of the Partnership With Physician, Dentist and Other Co-medical Stuff

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01403805
• Other study ID #: 803121
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: April 29, 2012
• Start date: November 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2012
• Source: Yubari Kibounomori
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia.

Description:

The elderly population can be expected to increase not only in developed countries, but also in developing countries. Pneumonia is one of the most common causes of death in the elderly.

The investigators conducted a prospective study comparing the effects of interventions (combined oral care and pneumococcal plus influenza vaccinations) in preventing pneumonia and increasing the survival rate from pneumonia in consecutive elderly patients at a nursing home in Yubari during one year from 2009, with the results in a non-intervention group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The residents or an agent who understand the purpose of this study and give informed consent.

Exclusion Criteria:

• The residents contraindicated to vaccine

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia

Intervention

Biological:
• Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
• Influenza vaccination (Flubik HA, 16100EZZ01207000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
• Influenza vaccination (Flubik HA, 16100EZZ01207000)
Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day

Other:
• Specific frequency of oral care
1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.

Locations

Country	Name	City	State
Japan	Yubari Kibounomori	Yubari	Hokkaido

Sponsors (2)

Lead Sponsor	Collaborator
Yubari Kibounomori	Health Research Foundation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Pneumonia	Number of Participants with Pneumonia sufferers	1 year	Yes
Secondary	Death From Pneumonia	Number of participants for the death from pneumonia	1 year	Yes