Enhanced Oral Health Care for Gum Disease in Pregnancy

(CHEER Trial)

CS
Overseen ByCHEER Study Manager
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of California, San Francisco
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve dental care for pregnant individuals with gum disease. It provides free dental check-ups and cleanings to determine if better oral health can lead to healthier pregnancies. Researchers compare two methods of dental care: one group receives a full care kit and weekly reminders (Enhanced Care +), while the other receives standard education (Enhanced Care). This trial suits those who are less than 20 weeks pregnant and show signs of gum disease. Participants must have dental insurance and receive prenatal care at specific clinics. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance dental care for pregnant individuals.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those on immunosuppressive or anti-inflammatory medications. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using products like toothbrushes, toothpaste, and floss during pregnancy does not cause any known harmful effects. However, detailed studies on these products for pregnant individuals are lacking. The Enhanced Care Plus treatment provides participants with these oral care tools and education to improve dental health.

Maintaining oral hygiene during pregnancy is generally safe and important. It helps prevent gum disease, which can otherwise increase the risk of early labor and low birth weight. Although specific data on the exact safety of the Enhanced Care Plus program is unavailable, the tools and practices used are common and have not shown harmful effects in similar contexts.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to managing gum disease during pregnancy. Unlike standard care, which often involves basic oral hygiene education, the "Enhanced Care +" method includes a comprehensive home oral care kit with a toothbrush, toothpaste, and floss. It also provides structured oral hygiene education and reinforces behavioral changes through weekly surveys. This holistic approach aims to not only improve oral health but also instill lasting habits, making it a potentially game-changing strategy for improving gum health in pregnant individuals.

What evidence suggests that this trial's treatments could be effective for gum disease in pregnancy?

Research has shown that maintaining oral health can reduce gum problems during and after pregnancy. For instance, gum disease in mothers links to a higher risk of early birth and smaller babies. Studies suggest that treating gum disease might improve pregnancy outcomes, though results can vary. In this trial, participants in the Enhanced Care Plus arm will receive a home oral care kit and regular educational support, which may help manage gum issues and improve oral health habits. This approach aims to support better pregnancy outcomes by enhancing oral health.16789

Who Is on the Research Team?

EI

Effie Ioannidou, DDS, MDS

Principal Investigator

University of California, San Francisco

LJ

Laura Jelliffe-Pawlowski, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

The CHEER study is for pregnant individuals over 18 with signs of gum disease, who have dental insurance, access to a mobile phone, and are less than 20 weeks into their pregnancy. They should be getting prenatal care at affiliated clinics and able to consent.

Inclusion Criteria

I am willing and able to give my consent to participate.
I am pregnant, over 18, and have gum disease.
I am less than 20 weeks pregnant.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive structured oral health interventions, including education and behavioral reinforcement, during pregnancy

28 weeks
Weekly surveys and periodic dental check-ups

Follow-up

Participants are monitored for changes in periodontal inflammation and oral health behaviors postpartum

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Enhanced Care
  • Enhanced Care +

Trial Overview

This study tests two noninvasive oral health interventions during pregnancy. It aims to see if either method reduces gum inflammation better during and after pregnancy and whether they improve oral health behaviors or birth outcomes.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: TestExperimental Treatment1 Intervention
Group II: ControlExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

Colgate Palmolive

Industry Sponsor

Trials
106
Recruited
19,100+

Noel Wallace

Colgate Palmolive

Chief Executive Officer since 2019

MBA from Harvard Business School

Diana Haussling

Colgate Palmolive

Chief Marketing Officer since 2022

Bachelor's degree in Marketing

Citations

CHEER Oral Health in Pregnancy Study

Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant ...

The impact of maternal gum disease on pregnancy outcomes ...

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Enhanced Oral Health Care for Gum Disease in Pregnancy ...

This study tests two noninvasive oral health interventions during pregnancy. It aims to see if either method reduces gum inflammation better during and after ...

Does Oral Health Impact Pregnancy Outcomes?

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Exploring the Influence of Oral Health on Pregnancy ...

Intervention trials show mixed results—some small studies report improved birth outcomes after periodontal treatment, while larger trials show ...

Oral Health Care During Pregnancy and Through the ...

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Periodontal Disease and Pregnancy: What's the Connection?

Effects of Gum Disease on Pregnancy Outcomes · Preterm labor · Low birth weight · Restriction of the baby's growth.

Extra care for expecting members - Delta Dental

It's estimated that nearly 60 to 75% of pregnant women have gingivitis, an early stage of gum disease. Tooth decay and cavities. Increased acidity in the oral ...

Improving Access to Dental Care for Pregnant Women

Periodontal disease (gum disease) during pregnancy increases the risk for delivering a preterm and/or low birth weight infant. Only 46% of U.S. ...