Comparison of Swabs and Toothbrushes in Cleaning the Teeth of Mechanically Ventilated Patients

NCT01154257 | Completed

• 1 other identifier: 09/MRE09/44
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Cleaning the mouth is difficult in critically ill patients who require support from a breathing machine (ventilator). This is because the plastic (endotracheal) tube which is a necessary interface between patient and ventilator impedes cleaning. New evidence suggests that poor oral health may be linked to ventilator associated pneumonia. Throughout the world both toothbrushes and foam swabs are used to clean the teeth and remove dental plaque, however it is unknown if one method is more effective than the other. The purpose of this study is to establish which (if any) method is most effective at removing plaque in this population of patients.

Conditions

Dental Plaque; Gingivitis

Keywords

Dental plaque; Gingivitis

Outcome Measures

Primary Outcomes (1)

• Modified Silness and Loe plaque and gingival index following cleaning of teeth

  The Silness and Loe plaque and gingival index scores plaque and gum disease as 0,1,2, or 3 for each tooth. The index is derived by adding scores and dividing by the number of teeth examined (maximum score 3, minimum 0). The index will be compared between teeth cleaned with a toothbrush versus those cleaned with a swab

  Daily until day seven

Secondary Outcomes (1)

• Quantitative comparisons of bacterial counts following the two cleaning methods

  Daily until day seven

Study Arms (2)

Cleaning teeth with toothbrush

EXPERIMENTAL

Following randomisation one side of the mouth (split mouth study) will be assigned to cleaning teeth with a toothbrush

Procedure: Cleaning of teeth with a toothbrush

Cleaning teeth with foam swab

EXPERIMENTAL

Following randomisation one side of the mouth (split mouth study) will be assigned to cleaning teeth with a faom swab

Procedure: Cleaning of teeth with a foam swab

Interventions

Cleaning of teeth with a toothbrush PROCEDURE

This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a toothbrush. Cleaning will be twice daily from recruitment until day seven.

Cleaning teeth with toothbrush

Cleaning of teeth with a foam swab PROCEDURE

This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a foam swab. Cleaning will be twice daily from recruitment until day seven.

Cleaning teeth with foam swab

Eligibility Criteria

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

You may qualify if:

• Patients aged \>18 years
• Patients mechanically ventilated with an oral endotracheal tube -\>20 teeth with symmetric distribution

You may not qualify if:

• Absence of an oral endotracheal tube
• Age \<18 years
• \<20 teeth or asymmetric distribution
• Expected to be intubated less than 24-hours from recruitment
• Thrombocytopaenia (platelet count \<30)
• Uncontrolled coagulopathy
• Suffering from facial or oral trauma

Sponsors & Collaborators

• Cardiff and Vale University Health Board: lead

Study Sites (1)

Adult Critical Care University Hospital of Wales

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

Location

Related Publications (1)

• Marino PJ, Hannigan A, Haywood S, Cole JM, Palmer N, Emanuel C, Kinsella T, Lewis MA, Wise MP, Williams DW. Comparison of foam swabs and toothbrushes as oral hygiene interventions in mechanically ventilated patients: a randomised split mouth study. BMJ Open Respir Res. 2016 Oct 14;3(1):e000150. doi: 10.1136/bmjresp-2016-000150. eCollection 2016.

  PMID: 27843549 DERIVED

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Study Officials

• Matt P Wise, DPhil

  University Hospital of Wales Cardiff & Vale University Health Board

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2010
• First Posted: June 30, 2010
• Study Start: June 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 31, 2023

Record last verified: 2020-01

Locations

GB (1)