Comparison of Swabs and Toothbrushes in Cleaning the Teeth of Mechanically Ventilated Patients
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ClinicalTrials.gov Identifier: NCT01154257 |
Recruitment Status :
Completed
First Posted : June 30, 2010
Last Update Posted : January 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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Dental Plaque Gingivitis | Procedure: Cleaning of teeth with a toothbrush Procedure: Cleaning of teeth with a foam swab | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 21 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Comparison of Foam Swabs Versus Toothbrushes in Removing Dental Plaque From Orally Intubated Mechanically Ventilated Patients |
Actual Study Start Date : | June 2010 |
Actual Primary Completion Date : | June 2011 |
Actual Study Completion Date : | June 2011 |
Arm | Intervention/treatment |
---|---|
Experimental: Cleaning teeth with toothbrush
Following randomisation one side of the mouth (split mouth study) will be assigned to cleaning teeth with a toothbrush
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Procedure: Cleaning of teeth with a toothbrush
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. |
Experimental: Cleaning teeth with foam swab
Following randomisation one side of the mouth (split mouth study) will be assigned to cleaning teeth with a faom swab
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Procedure: Cleaning of teeth with a foam swab
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. |
- Modified Silness and Loe plaque and gingival index following cleaning of teeth [ Time Frame: Daily until day seven ]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
- Quantitative comparisons of bacterial counts following the two cleaning methods [ Time Frame: Daily until day seven ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients aged >18 years
- Patients mechanically ventilated with an oral endotracheal tube ->20 teeth with symmetric distribution
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01154257
United Kingdom | |
Adult Critical Care University Hospital of Wales | |
Cardiff, South Glamorgan, United Kingdom, CF14 4XW |
Principal Investigator: | Matt P Wise, DPhil | University Hospital of Wales Cardiff & Vale University Health Board |
Responsible Party: | Cardiff and Vale University Health Board |
ClinicalTrials.gov Identifier: | NCT01154257 |
Other Study ID Numbers: |
09/MRE09/44 |
First Posted: | June 30, 2010 Key Record Dates |
Last Update Posted: | January 30, 2020 |
Last Verified: | January 2020 |
Dental plaque Gingivitis |
Gingivitis Dental Plaque Gingival Diseases Periodontal Diseases |
Mouth Diseases Stomatognathic Diseases Dental Deposits Tooth Diseases |