Infective Endocarditis (IE)SMILENCT07511673
The Study Tests if Preoperative Dental Screening is Superior to no Preoperative Dental Screening in Improving the Outcome of Patients Undergoing Surgical Cardiac Valve Replacement or Transcatheter Cardiac Valve Implantation.
A study testing Preoperative dental screening and No preoperative dental screening in people with Infective Endocarditis (IE) and Heart Valve Disease, run by Region Skane at 5 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis (IE), Heart Valve Disease
- What is being tested?
- Preoperative dental screening and No preoperative dental screening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 5 sitesSweden
- Study dates
- 6 May 2026to 1 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Accepted for cardiac valve intervention
- Able to provide informed consent
Who cannot join
- Previous or ongoing infective endocarditis
- Urgent surgery
- Pain from loose tooth/teeth
- Immunosuppressive therapy (excluding corticosteroids)
- Inability to provide informed consent
- Expected loss to follow-up
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Sweden5 sites, 5 recruiting
- Not yet recruiting
Sahlgrenska University Hospital
Gothenburg
Anders Jeppsson, Professor, 046313421000, anders.jeppsson@vgregion.se
- Not yet recruiting
Linköping University Hospital
Linköping
Farkas Vanky, Professor, +4610-1030000, farkas.vanky@regionostergotland.se
- Recruiting
Skane University Hospital
Lund
Anneli Olsson, RN-PhD, +46(0)46173723, anneli.t.olsson@skane.se
- Not yet recruiting
Örebro University Hospital
Örebro
Örjan Friberg, Ass prof, +4619-602 10 00, orjan.friberg@regionorebrolan.se
- Not yet recruiting
Karolinska University Hospital
Stockholm
Ulrik Sartipy, Professor, +46812370000
About this study
Official title: SMILE: A Randomized Trial of Preoperative Dental Screening for the Prevention of Endocarditis, Reoperation or Death in Patients Undergoing Surgical or Transcatheter Cardiac Valve Intervention.
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.
Read the detailed description
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:
- Preoperative dental screening
- No preoperative dental screening
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.
- Conditions
- Infective Endocarditis (IE), Heart Valve Disease
- Being tested
- Preoperative dental screening, No preoperative dental screening
- Keywords
- Dental screening, valve intervention, endocarditis, TAVI, valve surgery
- Medical subject headings
- Endocarditis, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative dental screeningOther
Dental examination prior to valve intervention; treatment performed if indicated.
No preoperative dental screeningOther
No routine dental screening prior to valve intervention.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative dental screening | Experimental | Preoperative dental examination with treatment if clinically indicated. Receives: Other: Preoperative dental screening |
| No preoperative dental screening | Active comparator | No routine dental screening prior to valve intervention. Receives: Other: No preoperative dental screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (6)
All-cause mortality
Measured: 2 years
Redo-intervention of index valve
Measured: 2 years
Definite infective endocarditis
Measured: 2 years
CIED extraction
Extraction of Cardiovascular Implantable Electronic Device (CIED)
Measured: 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.
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start6 May 2026
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective Endocarditis (IE)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrik Gilje, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511673
- Sponsor's protocol ID
- 2025-08978-01
- Other IDs
- 2025
- Acronym
- SMILE
- Status last verified
- May 2026
- First submitted
- 30 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMILE: A Randomized Trial of Preoperative Dental Screening for the Prevention of Endocarditis, Reoperation or Death in Patients Undergoing Surgical or Transcatheter Cardiac Valve Intervention.
- ClinicalTrials.gov ID
- NCT07511673
- Acronym / sponsor ID
- SMILE / 2025-08978-01
- Conditions
- Infective Endocarditis (IE), Heart Valve Disease
- Keywords
- Dental screening, valve intervention, endocarditis, TAVI, valve surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 6 May 2026 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2036 (estimated)
- First posted
- 6 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Preoperative dental screening
- No preoperative dental screening
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative dental screening | Experimental | Other: Preoperative dental screeningPreoperative dental examination with treatment if clinically indicated. |
| No preoperative dental screening | Active comparator | Other: No preoperative dental screeningNo routine dental screening prior to valve intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Accepted for cardiac valve intervention
- Able to provide informed consent
Key exclusion criteria (6 listed)
- Previous or ongoing infective endocarditis
- Urgent surgery
- Pain from loose tooth/teeth
- Immunosuppressive therapy (excluding corticosteroids)
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative dental screeningDental examination prior to valve intervention; treatment performed if indicated. | Other | Preoperative dental screening |
| No preoperative dental screeningNo routine dental screening prior to valve intervention. | Other | No preoperative dental screening |
Primary outcome
Composite outcome of death, redo-intervention, or infective endocarditis
Time frame: 2 years
Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis.
6 secondary outcomes
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
Time frame: 2 years
Oral health (GOHAI score)
Time frame: 3 months
Quality of life (EQ-5D-5L index and VAS score)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative dental screening and No preoperative dental screening in people with Infective Endocarditis (IE) and Heart Valve Disease, run by Region Skane at 5 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrik Gilje, MD-PhD (+46 (0)46171819, patrik.gilje@skane.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome of death, redo-intervention, or infective endocarditis (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.