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Trial record 1 of 1 for:    NCT03874962
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Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

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ClinicalTrials.gov Identifier: NCT03874962
Recruitment Status : Completed
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Kaohsiung Medical University Chung-Ho Memorial Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pneumonia Other: Routine oral cleaning and professional oral care group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improvements in Pneumonia Status and Salivary Bacterial Concentration After Professional Oral Care Intervention in Taiwanese Nursing Home Residents
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : September 1, 2015
Actual Study Completion Date : September 30, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Other: 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.
No Intervention: Routine oral cleaning group
The subjects in "Routine oral cleaning group" were received only routine oral cleaning, just maintain daily condition.


Outcome Measures
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Primary Outcome Measures :
  1. Pneumonia hospitalization status [ Time Frame: 2 hours ]
    Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.

  2. Bacterial concentrations [ Time Frame: 3 hours ]
    Total salivary and sputum bacterial concentrations were determined using real-time polymerase chain reaction. Staphylococcus aureus (strain ID: ATCC 29213) was used to create the standard growth curve of bacteria. After overnight culture, the samples were prepared by 5-fold serial dilution with normal saline and plating in a Petri dish to produce 2.5×103 to 3.9×107 CFU/mL of bacteria. Genomic DNA of bacteria was extracted from 1 mL of each bacterial serial solution using the modified standard method, which followed three basic steps: lysis, precipitation, and purification. The DNA extracts were resuspended in 20 µL of distilled water and stored at -80°C until real-time polymerase chain reaction (RT-PCR) amplification. The standard curve of bacterial concentration was generated by the bacterial 16S rRNA gene using a serial dilution of Staphylococcus aureus genomic DNA and StepOnePlus Real-Time PCR System (Applied Biosystems).


Secondary Outcome Measures :
  1. Oral health examinations [ Time Frame: 3 hours ]
    Oral health examinations were conducted by two trained dentists, and data on plaque, gingival, and tongue coating indexes were collected by oral examination tables.

  2. Demographic data [ Time Frame: 1 hour ]
    Demographic data included gender, age groups, conscious, educational level, and nutritional route, which were collected by questionnaire.


Eligibility Criteria
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Ages Eligible for Study:   51 Years to 102 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03874962


Sponsors and Collaborators
Kaohsiung Medical University Chung-Ho Memorial Hospital
Investigators
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Study Chair: Shun-Te Huang, Professor Kaohsiung Medical University Chung-Ho Memorial Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kaohsiung Medical University Chung-Ho Memorial Hospital
ClinicalTrials.gov Identifier: NCT03874962    
Other Study ID Numbers: KMUH103-3M47
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD for outcome measures will be made available.
Supporting Materials: Study Protocol
Time Frame: starting 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kaohsiung Medical University Chung-Ho Memorial Hospital:
Oral care intervention
Nursing home residents
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections