Reducing Risk for Infective Endocarditis (IE): A Randomized Trial of a Professional Scaling and Oral Hygiene Instruction Intervention to Reduce Tooth Brushing-Associated Bacteremia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 320
- 试验地点
- 11
- 主要终点
- Incidence of bacteremia
研究概览
简要总结
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.
详细描述
This multi-center randomized clinical trial will determine if an intervention to improve oral hygiene and reduce gingival inflammation decreases the incidence and duration of bacteremia of Infective Endocarditis (IE) causing bacterial species, which may refocus longstanding guidelines on prevention for all people at risk for Infective Endocarditis (IE). The Standardized Brushing Hygienist will brush the participant's teeth over a 2-minute period, during and after which there will be 4 additional blood samples. The participant will then be randomized to an intervention or routine care group. The intervention will consist of a single session of tooth scaling and polishing, and oral hygiene instruction provided at the end of the Randomization Visit. Both groups will return for 3-week and 15-week visits, during which they will undergo a non-invasive oral examination and the brushing procedure with 5 blood samples (baseline and 4 additional blood samples after brushing begins). All blood samples will be cultured for bacteria of IE causing species.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Greater than 6 months since last dental hygiene prophylaxis (cleaning).
- •10 or more accessible teeth (including implants, with a minimum of 8 natural teeth).
- •Willing and able to provide informed consent.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Willing to forgo routine professional dental cleanings while enrolled in the trial.
排除标准
- •At high risk for IE, as defined by the 2007/2021 AHA Guidelines:
- •Prosthetic cardiac valve or prosthetic material used for cardiac valve repair.
- •Previous episode of IE.
- •Cardiac transplantation recipient with cardiac valvulopathy.
- •Specific congenital heart disease conditions.
- •Pregnant, by self-report, or planning to become pregnant during the study period.
- •Affected by a condition that, in the opinion of the investigator, may preclude them from study completion or put them at increased risk such as :
- •Hemodialysis dependent.
- •Have a long-term intravascular catheter (e.g., for chemotherapy or parenteral nutrition).
- •Active injection drug use (IDU).
- •Clotting disorder such as, hemophilia.
- •Have a solid organ transplant or hematopoietic stem cell transplant, or ongoing treatment for hematologic cancer.
- •Currently incarcerated.
- •Systemic antibiotic use within the past 2 weeks.
- •Undergoing orthodontic treatment with fixed appliances (brackets and wires) or plans to do so during the study period.
- •Taking or requiring antibiotic prophylaxis prior to dental procedures for other reasons, e.g., to prevent prosthetic joint infection .
- •Three or more teeth with moderate to severe gingival hyperplasia.
- •Has clinically detectable emergent or urgent dental needs that, in the trained and calibrated Oral Examiner's opinion, would require definitive dental care during the study period.
研究组 & 干预措施
Participants receiving a dental cleaning and oral hygiene instruction
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.
干预措施: Oral Hygiene instruction (Behavioral)
Participants receiving a dental cleaning and oral hygiene instruction
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.
干预措施: Dental Cleaning (Procedure)
Control
Participants randomized to this arm will be instructed to continue with their usual oral hygiene practices for the duration of the study period.
结局指标
主要结局
Incidence of bacteremia
时间窗: Week 15
Blood samples are assessed for positivity of Infective Endocarditis (IE) causing oral species. A participant is defined as having bacteremia at a visit if that participant has at least one blood draw positive for bacteremia of IE-causing species during or after tooth brushing, provided that those IE-causing species were not present at the pre-brushing blood draw.
次要结局
- Change in calculus index scores(Baseline, Week 3, and Week 15)
- Change in gingival index scores(Baseline, Week 3, and Week 15)
- Change in duration of bacteremia score(Baseline, Week 3, and Week 15)
- Change in visible plaque scores(Baseline, Week 3, and Week 15)
- Change in Incidence of bacteremia(Baseline to Week 3)