Dental Care for Infective Endocarditis

(PIE-B Trial)

Recruiting at 4 trial locations

Overseen By Cathy Petersen, RDH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Antibiotics

Disqualifiers: Pregnancy, Cardiac conditions, Hemodialysis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if dental cleaning and improved brushing habits can prevent bacteria from entering the bloodstream after brushing teeth. Researchers will compare blood tests from two groups: one receiving a dental cleaning and oral hygiene tips, and the other maintaining their usual routine. It suits individuals who haven't had a dental cleaning in over six months and have at least ten teeth, including implants. Participants must be willing to forgo routine dental cleanings during the trial.

As an unphased study, this trial offers a unique opportunity to contribute to dental health research and potentially enhance personal oral hygiene practices.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are using systemic antibiotics, you must not have taken them in the past two weeks to be eligible.

What prior data suggests that dental cleaning and oral hygiene instruction are safe?

Research has shown that dental cleanings are generally safe and manageable. No reports link serious problems to standard dental cleanings. Studies have found that good oral care, including regular cleanings, is important for preventing infections like infective endocarditis, a heart infection, especially for those at high risk. Regular cleanings help prevent bacteria from entering the bloodstream during everyday activities like brushing teeth.

While some dental procedures might require antibiotics to prevent infection, standard cleanings usually do not. For most people, the risk from a dental cleaning is low. Always consult a healthcare provider if there are specific concerns about dental procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of regular dental cleaning and improved oral hygiene as a way to prevent infective endocarditis, a serious heart infection. Unlike standard treatment options, which often involve antibiotics or surgical interventions, this approach focuses on prevention through non-invasive methods. By emphasizing proper toothbrushing and flossing techniques, this trial aims to show that maintaining good oral health could reduce the risk of this condition, offering a simple and cost-effective alternative to more aggressive treatments.

What evidence suggests that dental cleaning and oral hygiene instruction could be effective for preventing bacteria in the bloodstream?

This trial will compare the effects of receiving a dental cleaning and oral hygiene instruction with continuing usual oral hygiene practices. Research has shown that regular dental check-ups can help control bacteria in the mouth. Although dental cleanings have not been definitively proven to prevent infective endocarditis (IE), a heart infection, maintaining oral health is generally beneficial. Studies indicate that dental treatments do not significantly increase the risk of IE, but good oral hygiene might reduce the number of bacteria entering the bloodstream. Regular dental visits, along with proper brushing and flossing, are recommended to maintain oral health and might help prevent infections. ^{6 7 8 9 10}

Who Is on the Research Team?

Peter Lockhart, DDS

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for adults over 18 who haven't had a dental cleaning in the last 6 months, have at least 10 teeth, and can follow study rules. It's not for pregnant women or those with conditions like clotting disorders, drug use, transplants, ongoing cancer treatment, recent antibiotics use, orthodontic braces, or high risk of infective endocarditis.

Inclusion Criteria

Willing to forgo routine professional dental cleanings while enrolled in the trial

Greater than 6 months since last dental hygiene prophylaxis (cleaning)

Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria

I am at high risk for infective endocarditis due to a heart condition.

Criterion: You have a condition or situation that could make it difficult to complete the study or may increase your risk, such as needing hemodialysis, having certain medical devices, active drug use, a clotting disorder, a recent organ transplant, ongoing cancer treatment, being incarcerated, recent antibiotic use, ongoing orthodontic treatment, needing antibiotic treatment before dental procedures, significant dental issues, or other medical concerns.

Pregnant, by self-report, or planning to become pregnant during the study period

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Intervention

Participants are randomized into intervention or control groups. The intervention group receives a dental cleaning and oral hygiene instruction.

1 day

1 visit (in-person)

Follow-up

Participants return for follow-up visits to assess oral health and bacteremia incidence.

15 weeks

2 visits (in-person) at Week 3 and Week 15

What Are the Treatments Tested in This Trial?

Interventions

• Dental Cleaning
• Oral Hygiene instruction

Trial Overview Researchers are testing if dental cleanings and better brushing education can prevent bacteria from entering the bloodstream after toothbrushing. Participants will be split into two groups: one receiving dental care and instructions; the other won't to compare blood test results.

How Is the Trial Designed?

Group I: Participants receiving a dental cleaning and oral hygiene instruction Experimental Treatment 2 Interventions

Participants randomized to this arm will receive a standard dental cleaning and education on proper toothbrushing and flossing technique and asked to follow these toothbrushing and flossing techniques for the duration of the study period. They will receive periodic phone call reminders to maintain these practices during the study period.

Group II: Control Active Control 1 Intervention

Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.

Dental Cleaning is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Dental Cleaning for:

• Prevention of Infective Endocarditis
• General Oral Health

Approved in European Union as Dental Prophylaxis for:

• Prevention of Infective Endocarditis
• General Oral Health

Approved in Canada as Professional Teeth Cleaning for:

• Prevention of Infective Endocarditis
• General Oral Health

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

An intervention program at the Dental Unit of Hospital Militar de Santiago revealed that cleaning and disinfection processes were inadequate, particularly highlighting the instrument holder unit as the most contaminated surface.

Post-intervention, significant reductions in contamination were observed on critical surfaces, demonstrating that training staff in proper cleaning and disinfection techniques is a cost-effective strategy to prevent healthcare-associated infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Importance of cleaning and disinfection of critical surfaces in dental health services. Impact of an intervention program]. Véliz, E., Vergara, T., Pearcy, M., et al.[2018]

In a systematic review of 4 studies involving 796 mechanically ventilated patients, combining 0.12% chlorhexidine with toothbrushing resulted in a 24% lower risk of ventilator-associated pneumonia (VAP) compared to chlorhexidine alone, although this finding was not statistically significant.

Despite the lack of strong evidence for a standard protocol, the study suggests that toothbrushing should be a common practice for mechanically ventilated patients, as it is a simple intervention that may help reduce the risk of VAP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination of toothbrushing and chlorhexidine compared with exclusive use of chlorhexidine to reduce the risk of ventilator-associated pneumonia: A systematic review with meta-analysis. Silva, PUJ., Paranhos, LR., Meneses-Santos, D., et al.[2022]

A study of 182 dentists in Aseer Region, Saudi Arabia, revealed that their knowledge about antibiotic prophylaxis for infective endocarditis (IE) is suboptimal, with only 30.8% correctly identifying root canal treatment as a procedure requiring prophylactic antibiotics.

While amoxicillin was the most commonly recommended antibiotic (90.7%), significant gaps in knowledge were noted, particularly regarding cardiac conditions needing prophylaxis, highlighting the need for updated training based on the latest AHA guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dentists' knowledge and practices about infective endocarditis antibiotics prophylaxis among children in aseer region, Southwestern Saudi Arabia. Shati, AA.[2022]

Antibiotic prophylaxis is commonly used to prevent infective endocarditis during dental procedures, especially in patients with diseased oral cavities, where the risk of bacteremia is higher.

Early identification of at-risk patients and timely referral to oral health specialists, combined with careful use of antibiotics and good oral health care, can significantly reduce the risk of infective endocarditis and its serious complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in dentistry. Montazem, A.[2007]

A survey of dental practitioners revealed that they often extend antibiotic prophylaxis to a wider range of dental procedures for 'high risk' patients than recommended by The British Society of Antimicrobial Chemotherapy (BSAC).

This discrepancy raises concerns about the potential for increased risk of infective endocarditis in these patients, highlighting the need for better awareness and guidelines regarding which dental procedures should require antibiotic coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Selection of dental procedures for antibiotic prophylaxis against infective endocarditis. Tan, SY., Gill, G.[2019]

Antibiotic prophylaxis for infective endocarditis is now recommended only for patients at the highest risk undergoing specific dental procedures, highlighting the need for careful patient selection.

Daily oral and skin hygiene practices are crucial for all patients, and dental implants can be safely used in high-risk individuals if their risk factors are carefully evaluated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention of Infective endocarditis]. Duval, X., Millot, S., Tubiana, S., et al.[2019]

In a randomized clinical trial involving 436 critical care patients on mechanical ventilation, adding manual toothbrushing to standard oral care with chlorhexidine did not significantly reduce the incidence of ventilator-associated pneumonia (VAP).

The study found that the rates of VAP were similar between patients who received toothbrushing (9.7%) and those who did not (11.0%), indicating that toothbrushing may not provide additional benefits in preventing VAP in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilator-associated pneumonia with or without toothbrushing: a randomized controlled trial. Lorente, L., Lecuona, M., Jiménez, A., et al.[2022]

Improper oral hygiene practices, such as vigorous toothbrushing and uncontrolled flossing, can lead to significant dental issues like tooth abrasion, gingival irritation, and even abscesses.

Certain oral hygiene products, including dentifrices and mouthwashes, may cause allergic reactions or injuries, highlighting the need for personalized instruction from dental professionals to ensure safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ill effects of improper oral hygeine procedure. Gillette, WB., Van House, RL.[2019]

Infective endocarditis prophylaxis has been a recommended preventive strategy for over 50 years, primarily involving antibiotic administration to high-risk patients before certain medical procedures.

Over the past 20 years, guidelines have shifted to limit antibiotic prophylaxis to only the highest-risk patients and interventions, while emphasizing non-antibiotic preventive measures and the importance of early diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Is infective endocarditis prophylaxis always recommended?]. Leport, C.[2019]

Approximately 14% of infective endocarditis cases are linked to dental treatments, highlighting the importance of dental care in preventing this serious condition.

Maintaining good dental hygiene is crucial, as 7% of infective endocarditis cases are associated with poor dental practices, underscoring the need for dental professionals to identify patients at moderate and high risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention of infective endocarditis during dental treatment]. Capuano, A., Bertini, L.[2016]

A study involving 78 healthy adults found that a high bioavailable, alcohol-free 0.07% cetylpyridinium chloride (CPC) rinse is as effective as a traditional alcohol-containing mouthwash (Listerine) in reducing plaque and gingivitis over a 21-day treatment period.

Both mouthwashes were well-tolerated by participants, indicating that the alcohol-free CPC rinse is a safe alternative for maintaining oral health without the side effects associated with alcohol-based rinses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative clinical trial of two antigingivitis mouthrinses. Witt, JJ., Walters, P., Bsoul, S., et al.[2022]

Infective endocarditis (IE) can occur due to bacteria entering the bloodstream during dental procedures, highlighting the importance of preventive measures in dental care.

Antibiotic prophylaxis is recommended for high-risk patients before dental treatments, emphasizing the need for timely administration 30-60 minutes prior to procedures, alongside improved dental hygiene and regular check-ups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevention of endocarditis in dentistry]. Ciurus, M.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11592561/

Antibiotic Prophylaxis Prior to Dental Procedures - PMC Recent meta-analyses have shown that the use of AP is associated with a lower risk of infective endocarditis after invasive dental procedures ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2022.06.030

Antibiotic Prophylaxis Against Infective Endocarditis Before ... Antibiotic prophylaxis (AP) before invasive dental procedures (IDPs) is recommended to prevent infective endocarditis (IE) in those at high IE risk.

3. ssph-journal.org ssph-journal.org/journals/public-health-reviews/articles/10.3389/phrs.2024.1607684/full

Risk of Infective Endocarditis Following Invasive Dental ... Our study found a strong association between invasive dental procedures and increased IE risk, particularly for tooth extraction and oral surgery in high-risk ...

4. journals.lww.com journals.lww.com/md-journal/fulltext/2015/10270/dental_procedures_and_the_risk_of_infective.41.aspx

Dental Procedures and the Risk of Infective Endocarditis Our data suggest that dental procedures do not significantly contribute to the risk of IE, arguing against the rationale behind the use of antibiotic ...

5. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.106.183095

Prevention of Infective Endocarditis | Circulation (2) Infective endocarditis prophylaxis for dental procedures is reasonable only for patients with underlying cardiac conditions associated with ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6491369/

Dental treatment and recommended management in ... The aim of this study is to describe and discuss all clinical implications related to IF and dental procedures, and AP before invasive dental procedures.

7. uptodate.com uptodate.com/contents/prevention-of-endocarditis-antibiotic-prophylaxis-and-other-measures/print

Prevention of endocarditis: Antibiotic prophylaxis and other ... On risk of endocarditis — Observational data suggest that antibiotic prophylaxis may reduce the risk of IE following invasive dental procedures ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2212440323000755

Oral hygiene and infective endocarditis: a case control study This is a case control study of oral hygiene among hospitalized patients with IE (cases) and outpatients with heart valve disease but without IE (controls).

9. aapd.org aapd.org/globalassets/media/policies_guidelines/bp_antibioticprophylaxis.pdf

Antibiotic Prophylaxis for Dental Patients at Risk for Infection Prophylactic antibiotics are recommended when patients with a high risk of adverse outcomes from bacteremia and infection undergo invasive oral/ dental ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11750435/

Risk of Infective Endocarditis Following Invasive Dental ... According to the results, patients were at risk of developing IE after tooth extraction and oral surgery procedures only in high IE-risk ...