Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

NCT ID: NCT03874962

Last Updated: 2019-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-09-30

Brief Summary

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The correlation between improvement in oral health, reduction in oral bacterial concentration, and status of pneumonia hospitalization remains unclear. To determine the effects of professional oral care intervention on the index of oral health, salivary and sputum bacterial concentrations, and pneumonia hospitalization status of nursing home residents using a quasi-experimental study. Two nursing homes were on demand selected as the intervention and control groups; in the intervention group, weekly professional oral care was administered in addition to regular oral care by trained dental hygienists. Demographic data and oral health status were analyzed. Total salivary and sputum bacterial concentrations were determined using real-time polymerase chain reaction.

Detailed Description

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Conditions

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Pneumonia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Routine oral cleaning and professional oral care group

The subjects in "Routine oral cleaning and professional oral care group" were received about routine oral cleaning and professional oral care.

Group Type EXPERIMENTAL

Routine oral cleaning and professional oral care group

Intervention Type OTHER

Besides routine oral cleaning was conducted by caregivers, professional oral care intervention was conducted by dental hygienists, and it included muscle massage, oral cleaning, and oral health education once a week.

Routine oral cleaning group

The subjects in "Routine oral cleaning group" were received only routine oral cleaning, just maintain daily condition.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Routine oral cleaning and professional oral care group

Besides routine oral cleaning was conducted by caregivers, professional oral care intervention was conducted by dental hygienists, and it included muscle massage, oral cleaning, and oral health education once a week.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Informed consent
* 51 year-old and above
* Being bedridden for ≥ 6 months
* Positive sputum production
* Difficulty in swallowing reported by caregivers

Exclusion Criteria

* Below 51 year-old
* Patients or family refused any oral care
Minimum Eligible Age

51 Years

Maximum Eligible Age

102 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shun-Te Huang, Professor

Role: STUDY_CHAIR

Kaohsiung Medical University Chung-Ho Memorial Hospital

References

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Cao Y, Liu C, Lin J, Ng L, Needleman I, Walsh T, Li C. Oral care measures for preventing nursing home-acquired pneumonia. Cochrane Database Syst Rev. 2022 Nov 16;11(11):CD012416. doi: 10.1002/14651858.CD012416.pub3.

Reference Type DERIVED
PMID: 36383760 (View on PubMed)

Chiang TC, Huang MS, Lu PL, Huang ST, Lin YC. The effect of oral care intervention on pneumonia hospitalization, Staphylococcus aureus distribution, and salivary bacterial concentration in Taiwan nursing home residents: a pilot study. BMC Infect Dis. 2020 May 27;20(1):374. doi: 10.1186/s12879-020-05061-z.

Reference Type DERIVED
PMID: 32460697 (View on PubMed)

Other Identifiers

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KMUH103-3M47

Identifier Type: -

Identifier Source: org_study_id

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