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NCT Number: NCT07377344

CHEER Oral Health in Pregnancy Study

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Enhanced Care

Behavioral

All participants receive standard oral hygiene education at the baseline visit.

Enhanced Care +

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Other outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

CHEER Study Manager

CONTACT

[email protected]

415-514-7900

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Colgate Palmolive

Registry information

Official study title

Closing Health Equity Through Empowering Oral Health for Maternal Wellness

Acronym: CHEER

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 29, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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