CHEER Oral Health in Pregnancy Study

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Gum Disease; Randomized Controlled Trial; Pregnancy Outcomes; Periodontal Disease; Dental Health; Pregnancy; Gingivitis

Treatments: Behavioral: Enhanced Care; Behavioral: Enhanced Care +

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07377344

20254330

Details and patient eligibility

About

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.

Full description

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.

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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Pregnant individuals aged 18 years or older with indications of periodontal diseases (gingivitis or mild periodontitis, moderate to severe periodontitis)
2. Less than 20 weeks pregnancy at time of enrollment
3. Has dental insurance (Medi-Cal or private coverage)
4. Willing and able to provide informed consent
5. Planning to receive ongoing prenatal care at study-affiliated clinics
6. Access to a mobile phone for receiving text messages

Exclusion criteria

1. Presence of systemic diseases or medical conditions that require antibiotic prophylaxis for dental procedures
2. Current immunosuppressive therapy/use of anti-inflammatory medications
3. Receipt of active periodontal treatment within the past 6 months
4. Complete edentulism (no natural teeth)
5. Unable to read and write English
6. Less than 9th grade education
7. Enrollment in another oral interventional study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

160 participants in 2 patient groups

Test

Experimental group

Description:

Enhanced Care + receive a home oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys

Treatment:

Behavioral: Enhanced Care +

Control

Other group

Description:

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

Treatment:

Behavioral: Enhanced Care