Effectiveness of Antibiotic Prophylaxis of Infective Endocarditis for Invasive Dental Procedures in Patients With Prosthetic Heart Valves and/or History of Infective Endocarditis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

Infective endocarditis (IE) continues to cause serious morbidity and mortality. To reduce its incidence, antibiotic prophylaxis has been recommended before invasive dental procedures in patients with at risk predispositions. Several studies have examined the effect of antibiotic prophylaxis on the incidence of IE and have brought conflicting results. The investigators aim to evaluate the effectiveness of antibiotic prophylaxis before invasive dental procedures to prevent oral streptococcal infective endocarditis in patients with prosthetic heart valves and/or history of IE, using a registry-based, cluster-randomized, controlled trial. In secondary objectives, the investigators aim to analyze changes in dentists' practices.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All French Health Territories (Territoires de santé, TDS) will be included and each TDS will contribute as a cluster for randomization.

All dentists working in each TDS will be included.

Among individuals receiving an invasive dental procedure, all patients aged 18 years or more identified with prosthetic heart valves or recorded with prior infective endocarditis will be included.

Disqualifiers

No exclusion criteria for health territories, dentists and patient.

However, dental procedures that had been performed less than 6 months after the date of first implantation of prosthetic heart valve won't be included.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Improved practices

    Other intervention

    A package of tools including: antibiotic prophylaxis guidelines reminders, periodic reminders, the Infectious Endocarditis Prevention Card for patients at risk, practical information targeting both dentists and patients, etc…

Treatment groups

250,000 Participants
are divided into 2 treatment groups
Group A: Intervention armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Diagnosis of infective endocarditis

Diagnosis of infective endocarditis due to oral streptococci that occurs within 3 months after an invasive dental procedure

Time frame
Within 3 months after an invasive dental procedure

Secondary outcomes

1

Antibiotic prophylaxis rate

Antibiotic prophylaxis rate in dentists according to their randomization arm (Health territories) in all patients regardless of the implantation of prosthetic heart valve and/or history of IE and their dental procedures (invasive or not). The antibiotic prophylaxis will be classified as appropriate (following the recommendation/intervention) or inappropriate

Time frame
21 days before the dental procedure

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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