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CompletedNCT03874962Updated Mar 14, 2019

Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

An interventional study of Routine oral cleaning and professional oral care group in Pneumonia, sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital. Completed. Open to participants aged 51 Years to 102 Years. Per ClinicalTrials.gov, last updated 2019-03-14.

Sponsored by Kaohsiung Medical University Chung-Ho Memorial Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 8 months after the study started (first participant enrolled Aug 2015, registered Apr 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
220
Allocation
Non-randomized
Ages
51 Years to 102 Years
Sex
All
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Study 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.

02

Conditions studied

  • Pneumonia

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Keywords

  • Oral care intervention
  • Nursing home residents
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 220 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital is the lead sponsor of 281 studies on the registry; 57 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
51 Years to 102 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Below 51 year-old
  • Patients or family refused any oral care
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • 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

  • No intervention
    Routine oral cleaning group

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

Interventions

  • OtherRoutine 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.

06

What researchers measure

Primary outcomes

  1. Pneumonia hospitalization status

    Hospitalization prevalence and days of each hospitalization due to pneumonia were collected from medical records by questionnaire.

    Time frame: 2 hours

  2. Bacterial concentrations

    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).

    Time frame: 3 hours

Secondary outcomes

  1. Oral health examinations

    Oral health examinations were conducted by two trained dentists, and data on plaque, gingival, and tongue coating indexes were collected by oral examination tables.

    Time frame: 3 hours

  2. Demographic data

    Demographic data included gender, age groups, conscious, educational level, and nutritional route, which were collected by questionnaire.

    Time frame: 1 hour

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 36383760 ↗
  • 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. PubMed 32460697 ↗

Individual participant data

Plan to share: Yes — De-identified IPD for outcome measures will be made available.

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03874962
Lead sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
Responsible party
Sponsor
First posted
Mar 14, 2019
Start date
Aug 1, 2015
Primary completion
Sep 1, 2015
Completion
Sep 30, 2017
Last update
Mar 14, 2019

Study contacts

Shun-Te Huang, Professor
study chair · Kaohsiung Medical University Chung-Ho Memorial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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