Trial Outcomes & Findings for Effects of the Oral Care With Vaccines for Pneumonia in Elderly; Going Home Together Both Physician and Dentist (NCT NCT01403805)

Results Overview

Number of Participants with Pneumonia sufferers

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

199 participants

Primary outcome timeframe

1 year

Results posted on

2012-05-01

Participant Flow

Participant milestones

Participant milestones
Measure	Influenza Vaccine Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Overall Study STARTED	94	105
Overall Study Pneumonia Diagnosis	21	2
Overall Study COMPLETED	94	98
Overall Study NOT COMPLETED	0	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Influenza Vaccine Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Overall Study Withdrawal by Subject	0	4
Overall Study Lost to Follow-up	0	2
Overall Study Death	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Influenza Vaccine n=94 Participants Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines n=105 Participants Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.	Total n=199 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	92 Participants n=5 Participants	105 Participants n=7 Participants	197 Participants n=5 Participants
Age Continuous	85.0 years STANDARD_DEVIATION 7.48 • n=5 Participants	86.0 years STANDARD_DEVIATION 7.64 • n=7 Participants	85.5 years STANDARD_DEVIATION 7.56 • n=5 Participants
Sex: Female, Male Female	66 Participants n=5 Participants	77 Participants n=7 Participants	143 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	28 Participants n=7 Participants	56 Participants n=5 Participants
Region of Enrollment Japan	94 participants n=5 Participants	105 participants n=7 Participants	199 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Number of Participants with Pneumonia sufferers

Outcome measures

Outcome measures
Measure	Influenza Vaccine n=94 Participants Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines n=105 Participants Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Number of Participants With Pneumonia	21 participants	2 participants

SECONDARY outcome

Timeframe: 1 year

Number of participants for the death from pneumonia

Outcome measures

Outcome measures
Measure	Influenza Vaccine n=94 Participants Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines n=105 Participants Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Death From Pneumonia	8 participants	1 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: These participants were followed for the duration of nursing home stay, an average of 22 weeks.

Population: These participants were determined as "Not Completed" due to "Leaving nursing home". We excluded these participants from analysis for outcome measure.

Numer of resident for leaving nursing home

Outcome measures

Outcome measures
Measure	Influenza Vaccine n=2 Participants Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Leaving Nursing Home	2 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: This participant rejected oral care before treatment, Day 1

Population: This participant was determined as "Not Completed" due to "Reject oral care". We excluded this participant from analysis for outcome measure.

Number of resident to reject oral care

Outcome measures

Outcome measures
Measure	Influenza Vaccine n=1 Participants Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Reject Oral Care	1 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: These participants rejected vaccine before treatment, Day 1

Population: These participants were determined as "Not Completed" due to "Reject vaccine". We excluded these participants from analysis for outcome measure.

Number of resident to reject vaccine

Outcome measures

Outcome measures
Measure	Influenza Vaccine n=3 Participants Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Reject Vaccine	3 participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: This participant was died before treatment, Day 1

Population: This participant was determined as "Not Completed" due to "Died before oral care starting". We excluded this participant from analysis for outcome measure.

Number of resident died before the start of oral care

Outcome measures

Outcome measures
Measure	Influenza Vaccine n=1 Participants Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Died Before Oral Care Starting	1 participants	—

Adverse Events

Influenza Vaccine

Serious events: 8 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Care With Influenza and Pneumococcal Vaccines

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Influenza Vaccine n=94 participants at risk Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).	Oral Care With Influenza and Pneumococcal Vaccines n=105 participants at risk Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following; 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. At the same time, we 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.
Infections and infestations Died in period	8.5% 8/94 • Number of events 8 • 1 year Died in Period from pneumonia	0.95% 1/105 • Number of events 1 • 1 year Died in Period from pneumonia
Infections and infestations Died before trial	0.00% 0/94 • 1 year Died in Period from pneumonia	0.95% 1/105 • Number of events 1 • 1 year Died in Period from pneumonia

Other adverse events

Adverse event data not reported

Additional Information

Dr. Masahiro Hatta

Department of Dentistry, Yubari Kibounomori, Japan

Phone: +81-123-52-4339

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place