GingivitisCHEERNCT07377344
CHEER Oral Health in Pregnancy Study
A study testing Enhanced Care and Enhanced Care + in people with Gingivitis and Dental Health, run by University of California, San Francisco at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gingivitis, Dental Health, Pregnancy
- What is being tested?
- Enhanced Care and Enhanced Care +
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2026to 31 Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UCSF Dental Center
San Francisco, California, 94143
UCSF Dental Center, 415-514-7900, cheer@ucsf.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Gingivitis, Dental Health, Pregnancy, Pregnancy Outcomes, Randomized Controlled Trial, Periodontal Disease
- Being tested
- Enhanced Care, Enhanced Care +
- Medical subject headings
- Gingivitis, Periodontal Diseases, Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced CareBehavioural
All participants receive standard oral hygiene education at the baseline visit.
Enhanced Care +Behavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Enhanced Care + receive a home oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys Receives: Behavioral: Enhanced Care + |
| Control | Other | 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 Receives: Behavioral: Enhanced Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in periodontal inflammation
Change in periodontal inflammation by survey and exam from baseline to 28-<36 weeks gestation to postpartum follow-up.
Measured: 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
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start29 Sep 2026
- Primary completion30 Sep 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Colgate Palmolive
- Responsible party
- Sponsor
- Investigators
- Effie Ioannidou, DDS, MDS, Principal investigator, University of California, San FranciscoLaura Jelliffe-Pawlowski, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377344
- Sponsor's protocol ID
- 20254330
- Acronym
- CHEER
- Status last verified
- Oct 2026
- First submitted
- 12 Jan 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No