CHEER Oral Health in Pregnancy Study (CHEER)

April 1, 2026 updated by: University of California, San Francisco

Closing Health Equity Through Empowering Oral Health for Maternal Wellness

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: CHEER Study Manager
  • Phone Number: 415-514-7900
  • Email: cheer@ucsf.edu

Study Locations

    • California
      • San Francisco, California, United States, 94143
        • UCSF Dental Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Enhanced Care + receive a home oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys
All participants receive standard oral hygiene education at the baseline visit. Test participants also receive a home oral care kit (toothbrush, toothpaste, and floss), and will start receiving weekly oral health check-ins and reminder surveys following their initial visits at one-week intervals starting the day after their baseline visit
Other: 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
All participants receive standard oral hygiene education at the baseline visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in periodontal inflammation
Time Frame: 28 weeks
Change in periodontal inflammation by survey and exam from baseline to 28-<36 weeks gestation to postpartum follow-up.
28 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in oral health behaviors
Time Frame: 28 weeks
Change in patient reported 1) teeth brushing twice a day, 2) teeth brushing for two minutes each time, 3) daily use of floss among test and control participants
28 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in birth outcomes between test and control groups
Time Frame: 28 weeks
Exploratory outcome: Differences between test and control participants: total weeks gestational age at delivery, preterm birth (<37 gestational weeks), birthweight (in grams), low birth weight delivery (<2500 grams), growth for gestational age percentile, and small for gestational age infant (infant birth weight lower than 10th percentile).
28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Effie Ioannidou, DDS, MDS, University of California, San Francisco
  • Principal Investigator: Laura Jelliffe-Pawlowski, PhD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

January 12, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 20254330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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