Improvements in Pneumonia Status After Oral Care Intervention in Taiwan

NCT03874962 | Completed

• 1 other identifier: KMUH103-3M47
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pneumonia

Keywords

Oral care intervention; Nursing home residents

Outcome Measures

Primary Outcomes (2)

• Pneumonia hospitalization status

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

  2 hours

• 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).

  3 hours

Secondary Outcomes (2)

• Oral health examinations

  3 hours

• Demographic data

  1 hour

Study Arms (2)

Routine oral cleaning and professional oral care group

EXPERIMENTAL

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

Routine oral cleaning group

NO INTERVENTION

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

Interventions

Routine oral cleaning and professional oral care group 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 and professional oral care group

Eligibility Criteria

• Age: 51 Years - 102 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Kaohsiung Medical University Chung-Ho Memorial Hospital: lead

Related Publications (2)

• 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.

  PMID: 36383760 DERIVED

• 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.

  PMID: 32460697 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Shun-Te Huang, Professor

  Kaohsiung Medical University Chung-Ho Memorial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: March 14, 2019
• Study Start: August 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 30, 2017
• Last Updated: March 14, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: starting 6 months after publication