Frequency of Oral Care Intervention Study

NCT ID: NCT02289131

Last Updated: 2018-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-03-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Respiratory Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Frequency of Once a Day

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

Group Type EXPERIMENTAL

Tooth Brushing Protocol

Intervention Type PROCEDURE

A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.

Frequency of Twice a Day

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)

Group Type EXPERIMENTAL

Tooth Brushing Protocol

Intervention Type PROCEDURE

A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.

Frequency of Three Times a Day

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)

Group Type EXPERIMENTAL

Tooth Brushing Protocol

Intervention Type PROCEDURE

A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.

Interventions

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Tooth Brushing Protocol

A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Tampa General Hospital

OTHER

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cindy L Munro, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Kevin E Kip, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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Tampa General Hospital

Tampa, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2R01NR007652-10A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PRO 00016479

Identifier Type: -

Identifier Source: org_study_id

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