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

Trial Summary

What is the purpose of this trial?

This clinical trial is studying if bacteria found in a participant's bloodstream after brushing their teeth can be prevented with a dental cleaning and more education on how to best brush and care for their teeth. One group of participants will have a dental cleaning and oral health instructions and the other group of participants will not. Researchers will compare the blood test results from the two groups to see if the education made a difference in preventing bacteria and how long it stays in the bloodstream.

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 data supports the effectiveness of the treatment Dental Cleaning, Dental Prophylaxis, Professional Teeth Cleaning, Oral Hygiene instruction, Oral Health Education, Dental Hygiene Instruction for preventing infective endocarditis?

Research suggests that maintaining good dental hygiene and regular professional teeth cleaning can help prevent infective endocarditis, as poor dental hygiene is linked to a higher risk of this heart infection. Regular dental care is emphasized as an essential precaution to reduce the risk of infective endocarditis. ^{1 2 3 4 5}

Is dental care generally safe for humans?

Dental care, including practices like toothbrushing and flossing, is generally safe for humans, but improper use can cause issues like gum irritation or tooth abrasion. It's important to follow proper techniques to avoid these problems. ^{6 7 8 9 10}

How does dental cleaning differ from other treatments for infective endocarditis?

Dental cleaning focuses on maintaining good oral hygiene to prevent bacteria from entering the bloodstream and causing infective endocarditis, unlike traditional treatments that often involve antibiotics for high-risk patients. This approach emphasizes regular dental care and hygiene as a preventive measure rather than relying solely on medication. ^{1 2 3 11 12}

Research Team

Peter Lockhart, DDS

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. France pubmed.ncbi.nlm.nih.gov

[Is infective endocarditis prophylaxis always recommended?]. [2019]

2. Italy pubmed.ncbi.nlm.nih.gov

[Prevention of infective endocarditis during dental treatment]. [2016]

3. India pubmed.ncbi.nlm.nih.gov

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

4. United States pubmed.ncbi.nlm.nih.gov

Antibiotic prophylaxis in dentistry. [2007]

5. England pubmed.ncbi.nlm.nih.gov

Selection of dental procedures for antibiotic prophylaxis against infective endocarditis. [2019]

6. Chile pubmed.ncbi.nlm.nih.gov

[Importance of cleaning and disinfection of critical surfaces in dental health services. Impact of an intervention program]. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Comparative clinical trial of two antigingivitis mouthrinses. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Ill effects of improper oral hygeine procedure. [2019]

9. Germany pubmed.ncbi.nlm.nih.gov

Ventilator-associated pneumonia with or without toothbrushing: a randomized controlled trial. [2022]

10. United States 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. [2022]

11. Poland pubmed.ncbi.nlm.nih.gov

[Prevention of endocarditis in dentistry]. [2021]

12. France pubmed.ncbi.nlm.nih.gov

[Prevention of Infective endocarditis]. [2019]