Effect of Toothbrushing Without Chlorhexidine on Oral Hygiene Indices in Patients With Orotrachea… (NCT06453122) | Clinical Trial Compass
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Effect of Toothbrushing Without Chlorhexidine on Oral Hygiene Indices in Patients With Orotracheal Intubation
Brazil70 participantsStarted 2024-03-15
Plain-language summary
The oral hygiene method commonly used in intubated patients orotracheal is tooth brushing (mechanical removal) and washing the oral cavity and the orotracheal tube (TOT) with digluconate solution chlorhexidine (CLX). However, recent studies have demonstrated that the use of CLX in these conditions may expose the patient to a potential increased risk of mortality. Recent recommendations made by international bodies related to hospital biosafety no longer include the use of CLX in ICU oral hygiene routine. A question not yet answered in the literature is whether the absence of CLX in the critical patient's oral hygiene routine predisposes increased accumulation of dental plaque or microbial colonization related to the risk of systemic complications, such as pneumonia and sepsis. The cost-effectiveness of this protocol change also needs to be evaluated, as the withdrawal of CLX may result in changes in the risk profile morbidity and mortality during hospitalization. The present study aims to investigate whether brushing the oral cavity with mineral water changes the pattern of biofilm accumulation and clinical appearance of the oral mucosa in relation to brushing done with CLX. Microbiological analysis of the oropharyngeal biofilm and cost-effectiveness impact assessment will also be carried out.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients admitted to the adult ICU;
* age over 18;
* both sexes;
* orotracheal intubation monitored from the first day;
* absence of foci of infection in the oral cavity (periapical lesions,
* periodontal abscesses, extensive cavities, opportunistic infections);
* presence of at least five teeth per dental arch
Exclusion Criteria:
* patients in whom oral hygiene is not possible;
* patients extubated before 24 hours from baseline;
* patients with foci of infection in the oral cavity present in the baseline moment;
* patients who died before 24 hours from baseline;
* patients whose guardians do not authorize the research to be carried out;
* patients whose information about oral and general health and other study variables are not available in the medical record, are doubtful or not capable of collection.
* patients after heart surgery
* patients with reintubation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Analyze oral cavity brushing
Timeframe: T0 (baseline) - first day of intubation; • T1 - after 3 days of intubation or immediately after extubation (with a minimum of 1 day of intubation); • T2 - after 7 days of intubation (if you still remain intubated).