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Non-Surgical Periodontal Treatment associated with Oral Hygiene in ICU patients

Non-Invasive Periodontal Treatment Protocol associated with Mechanical Control and Oral Biofilm Chemistry in ICU patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-6gs2ss2
Enrollment
Unknown
Registered
2025-10-23
Start date
2022-02-08
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Interventions

This is a randomized clinical trial, randomization was performed using sealed envelopes, involving patients hospitalized in Intensive Care Units. The objectives of this study were (1) to evaluate whet
Group 2 received supragingival scaling with portable dental ultrasound, and oral hygiene performed by the DS, with the remainder performed according to the hospital routine
Group 3 received supragingival scaling with hand instruments, Gracey periodontal curettes, and routine hospital oral hygiene
and Group 4 received only routine hospital oral hygiene. Oral hygiene performed by the dentist, depending on the group, was performed daily, once a day, throughout the ICU stay. A disposable toothbrus
E06.640

Sponsors

Christiane Mazurek Moraes
Lead Sponsor
Faculdade de Odontologia da Universidade do Estado do Rio de Janeiro
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients aged =18 who reported the presence of teeth; Patients hospitalized in the ICUs of the Pedro Ernesto University Hospital; and with the possibility of performing the periodontal examination and supragingival scaling in the first 48 hours in the intervention group

Exclusion criteria

Exclusion criteria: Edentulous patients; Pregnant or breastfeeding patients; Intubated patients (orotracheal tube); Patients with orthodontic; Patients allergic to chlorhexidine; Patients with lung images that could interfere with the diagnosis of pneumonia; Patients with suspected or diagnosed pneumonia; Patients with cardiac pacemakers; Patients undergoing interventions by Oral and Maxillofacial Surgery and/or Head and Neck Surgery which would make periodontal examination impossible and Patients with coagulation problems and others contraindicated by the medical team

Design outcomes

Primary

MeasureTime frame
"Expected outcome 1": It was expected that the intervention groups, after periodontal treatment and oral hygiene monitoring, would develop fewer episodes of nosocomial pneumonia, with a reduction of approximately 20%. The primary outcome was a reduction in the number of nosocomial pneumonias. The sample size calculation was performed using the G Power 3.1 program (Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany) using the paired t-test for independent samples. It was based on previous studies and considered nosocomial pneumonia as the primary outcome, with an effect size of 0.9259284, a power of 0.80, and an alpha value of 0.05. The minimum sample size required for each treatment group was 15 patients.;"Outcome found 1": Periodontal treatment was not able to reduce the number of episodes of nosocomial pneumonia.

Secondary

MeasureTime frame
No secondary outcomes are expected.

Countries

Brazil

Contacts

Public ContactChristiane Moraes

Faculdade de Odontologia da Universidade do Estado do Rio de Janeiro

chrismazumoraes@gmail.com55 2128688287

Outcome results

None listed

Source: REBEC (via WHO ICTRP)