Frequency of Oral Care Intervention Study (FOCIS)

University of South Florida

Status: Completed

Conditions: Respiratory Failure

Treatments: Procedure: Tooth Brushing Protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02289131

PRO 00016479

2R01NR007652-10A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Tooth brushing for patients with breathing tubes is routinely provided by the bedside nurse as part of clinical care. The purpose of this study is to determine how often tooth brushing should occur for adult patients with breathing tubes (mechanical ventilation), balanced with equivalence and safety.

Full description

A total of 345 adult subjects who are intubated and require mechanical ventilation will be randomly assigned to one of the three different tooth brushing frequency groups: once a day, twice a day or three times a day, up to a maximum of seven days. Teeth will be brushed with a soft child size toothbrush will take approximately 2 minutes. Following tooth brushing, the mouth will be rinsed with alcohol-free mouthwash and oral fluids will be removed with an oral suction tip. Moisturizing gel will be gently applied. The complete intervention requires approximately 15 minutes.

Information will be collected will include clinical condition, medications, age, gender, and smoking status. Once every day, digital pictures will be taken of each tooth (takes approximately five minutes) using a small intraoral camera to be evaluated for plaque by a dental hygienist that is blinded to frequency group assignment. Once every day, gingival crevicular fluid samples (takes 30 seconds) to look for factors that predict infection.

Gingival crevicular fluid samples and digital pictures of the teeth will also be collected on day 1, day 3 and day 5 after extubation.

Enrollment: 232 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• within 36 hours of initial intubation,
• have at least one tooth, and
• they or their legally authorized representative are able to provide informed consent in English or Spanish.

Exclusion criteria

• anticipation by the clinical provider of imminent patient death, or
• medical contraindication to tooth brushing.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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232 participants in 3 patient groups

Frequency of Once a Day

Experimental group

Description:

Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours)

Treatment:

Procedure: Tooth Brushing Protocol

Frequency of Twice a Day

Experimental group

Description:

Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 1:00 pm (+/- 1.5 hours)

Treatment:

Procedure: Tooth Brushing Protocol

Frequency of Three Times a Day

Experimental group

Description:

Tooth Brushing Protocol to be provided at 8:00 am (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 1:00 pm (+/- 1.5 hours) Tooth Brushing Protocol to be provided at 6:00 pm (+/- 1.5 hours)

Treatment:

Procedure: Tooth Brushing Protocol