An interventional study of Preoperative dental screening and No preoperative dental screening in Infective Endocarditis (IE) and Heart Valve Disease, sponsored by Region Skane. Recruiting at 5 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Region Skane · Not applicable, Interventional, and Treatment
This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention. Participants are randomized 1:1 to preoperative dental screening or no screening. The primary outcome is time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis within 2 years. The study uses registry-based follow-up to ensure complete outcome ascertainment.
Infective endocarditis is associated with high morbidity and mortality in patients with prosthetic heart valves. Current recommendations for preoperative dental screening are based on observational data, and randomized evidence is lacking.
This is a pragmatic, multicenter, randomized controlled trial conducted in Sweden. Patients accepted for surgical or transcatheter valve intervention are randomized 1:1 to:
Dental treatment in the intervention group is performed according to clinical practice. No routine dental screening is performed in the control group.
The primary endpoint is a composite of all-cause death, redo-intervention of the index valve, and definite infective endocarditis within 2 years.
All analyses will follow the intention-to-treat principle using time-to-event methods.
173 studies on the registry are indexed under Endocarditis; 57 are open to participants now.
This study's planned enrollment of 1,300 is above the median of 92 across 86 interventional studies indexed under Endocarditis.
Browse Endocarditis studies →Region Skane is the lead sponsor of 386 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Preoperative dental examination with treatment if clinically indicated.
Other: Preoperative dental screening
No routine dental screening prior to valve intervention.
Other: No preoperative dental screening
Dental examination prior to valve intervention; treatment performed if indicated.
No routine dental screening prior to valve intervention.
Composite outcome of death, redo-intervention, or infective endocarditis
Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis.
Time frame: 2 years
All-cause mortality
Time frame: 2 years
Redo-intervention of index valve
Time frame: 2 years
Definite infective endocarditis
Time frame: 2 years
CIED extraction
Extraction of Cardiovascular Implantable Electronic Device (CIED)
Time frame: 2 years
Oral health (GOHAI score)
The GOHAI consists of 12 items with a total score ranging from 12 to 60, where higher scores indicate better oral health-related quality of life.
Time frame: 3 months
Quality of life (EQ-5D-5L index and VAS score)
The EQ-5D-5L descriptive system generates an index value typically ranging from less than 0 (worse than death) to 1 (full health), where higher values indicate better health-related quality of life. The EQ Visual Analogue Scale (EQ VAS) ranges from 0 to 100, where higher scores indicate better perceived health.
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Dec 2030, 54 months after the start.
Of 34 interventional studies with no phase under Endocarditis, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 59. This study's planned 54 months is above that.
How these figures are worked out, and which studies are left out of them.
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