CHEER Oral Health in Pregnancy Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of California, San Francisco

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: TestExperimental treatment 1 intervention
Group B: ControlOther 1 intervention

Trial outcomes

Primary outcomes

1

Change in periodontal inflammation

Change in periodontal inflammation by survey and exam from baseline to 28-\<36 weeks gestation to postpartum follow-up.

Time frame
28 weeks

Secondary outcomes

1

Changes in oral health behaviors

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

Time frame
28 weeks

Other outcomes

1

Difference in birth outcomes between test and control groups

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).

Time frame
28 weeks

Sponsors and contacts

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