Closing Health Equity Through Empowering Oral Health for Maternal Wellness
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in periodontal inflammation
研究概览
简要总结
Many pregnant people don't get the dental care they need, even though it's safe and important. The CHEER Study offers free dental check-ups, cleanings, and supplies to help participants take care of their teeth and gums during pregnancy. The purpose of this research study is to compare two types of noninvasive oral health interventions to evaluate their effectiveness. We want to learn if one method is more effective in supporting oral health and improving pregnancy outcomes. There are two aims of this study:
Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease.
Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.
详细描述
The Closing Health Equity through Empowering Oral Health for Maternal Wellness (the CHEER Oral Health in Pregnancy Study) aims to address significant oral health disparities experienced by pregnant individuals, particularly those from low-income and minority communities in California.
Oral health is a critical yet often overlooked component of prenatal care. Existing evidence suggests that periodontal disease is associated with adverse pregnancy outcomes, such as preterm birth and low birth weight. However, many pregnant individuals in California do not receive adequate oral health services, especially those from historically marginalized communities. The CHEER Project aims to address this gap by implementing an intervention that is scalable, community-engaged, and grounded in evidence-based education.
This study will generate novel data on the impact of oral health education and behavior modification, delivered through accessible messaging and product use, on periodontal inflammation and disease status, and microbiome profiles. It will also explore potential downstream effects on perinatal outcomes. The study aligns with public health priorities to improve maternal wellness, health equity, and the integration of dental and medical care.
There are two study aims:
Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant individuals aged 18 years or older with indications of periodontal diseases (gingivitis or mild periodontitis, moderate to severe periodontitis)
- •Less than 20 weeks pregnancy at time of enrollment
- •Has dental insurance (Medi-Cal or private coverage)
- •Willing and able to provide informed consent
- •Planning to receive ongoing prenatal care at study-affiliated clinics
- •Access to a mobile phone for receiving text messages
排除标准
- •Presence of systemic diseases or medical conditions that require antibiotic prophylaxis for dental procedures
- •Current immunosuppressive therapy/use of anti-inflammatory medications
- •Receipt of active periodontal treatment within the past 6 months
- •Complete edentulism (no natural teeth)
- •Unable to read and write English
- •Less than 9th grade education
- •Enrollment in another oral interventional study
研究组 & 干预措施
Test
Enhanced Care + receive a home oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys
干预措施: Enhanced Care + (Behavioral)
Control
Participants receive "enhanced care" where they received standard oral hygiene education at the baseline visit. Do NOT receive oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys
干预措施: Enhanced Care (Behavioral)
结局指标
主要结局
Change in periodontal inflammation
时间窗: 28 weeks
Change in periodontal inflammation by survey and exam from baseline to 28-\<36 weeks gestation to postpartum follow-up.
次要结局
- Changes in oral health behaviors(28 weeks)
- Difference in birth outcomes between test and control groups(28 weeks)