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Not yet recruiting NCT07377344

CHEER Oral Health in Pregnancy Study

No phase Interventional Gingivitis Dental Health Pregnancy Pregnancy Outcomes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Enhanced Care, Enhanced Care +.
Who it may be relevant to
Registry conditions: Gingivitis, Dental Health, Pregnancy, Pregnancy Outcomes. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Closing Health Equity Through Empowering Oral Health for Maternal Wellness

Overview

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.

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.

Interventions

  • Behavioral Enhanced Care
    All participants receive standard oral hygiene education at the baseline visit.
  • Behavioral Enhanced Care +
    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 outcome measures

  • Change in periodontal inflammation [Time frame: 28 weeks]
Secondary outcome measures (1)
  • Changes in oral health behaviors [Time frame: 28 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • UCSF Dental Center — San Francisco

Identifiers

NCT: NCT07377344 · 20254330

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗