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Preventive Oral Care

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00800696
Enrollment
0
Registered
2008-12-02
Start date
2015-09-30
Completion date
2019-09-30
Last updated
2018-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fever, Respiratory Infection

Keywords

antibiotics, Hospitalization, oral care

Brief summary

The purpose of the investigators project is to examine if the investigators may affect a reduction in respiratory infections in a pediatric long term care facility by institution of a comprehensive oral care program. The investigators wish to base their project on work such as of Yoneyama et al 2002, which hypothesized and showed that silent aspiration of oropharyngeal contents is a causative factor in development of respiratory infection in elderly institutionalized clients. It was found that an advanced oral hygiene program greatly reduced the incidence of respiratory infection. Although no similar research projects were found to have involved children, the investigators hope that a similar program of oral care will allow the investigators to likewise reduce the incidence of respiratory infection among the pediatric clients in our facility. The investigators propose to examine two groups of children which are fed by gastrostomy feedings only. One group will continue to receive oral care as performed today. The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx. The investigators will retrospectively examine our records (a 12 month period) for febrile days, antibiotic use and hospitalization days due to respiratory causes. The investigators will then compare these to the febrile days, antibiotic use and hospitalizations to the 12 month period \[post implementation of the oral care program. The importance of this program is to examine whether by implementation of a relatively inexpensive and low-tech intervention may meaningfully reduce the morbidity and mortality due to respiratory infection among our clients (which from our experience is the main cause of morbidity and mortality in the investigators institution). The investigators expect that by reducing the incidence of respiratory disease among our clients that the investigators will greatly reduce suffering among the children and their families, improve their quality of life and ease the financial and organizational burdens as a result of caring for respiratory infections. As was noted before, no prior research was found which studied the pediatric population in a long term care facilities. It is our belief that this project represents a unique research opportunity which may bring great benefit to the children and caregivers.

Interventions

PROCEDUREoral care

The study group will have their teeth brushed three times a day by the nursing staff by using a suction connected toothbrush, daily examination of the oropharynx by the nursing staff, and use of chlorhexidine varnish or another suitable antibacterial agent in the oropharynx

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Months to 40 Years
Healthy volunteers
No

Inclusion criteria

* Clients who receive gastrostomy feedings only * ALEH Infirmary

Exclusion criteria

* Oral Feeding

Design outcomes

Primary

MeasureTime frame
Hospitalization days per yearyear

Secondary

MeasureTime frame
Feveryear

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026