Recruiting

Oral Health Intervention

Sponsor:

UCLA

Code:

NCT07377344

Conditions

Gingivitis

Dental Health

Pregnancy

Pregnancy Outcomes

Randomized Controlled Trial

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Enhanced Care

Enhanced Care +

Study Details

Brief 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. 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.

Conditions

Gingivitis

Dental Health

Pregnancy

Pregnancy Outcomes

Randomized Controlled Trial

Study ID

NCT07377344

Start date

Sep 29, 2026

Status verified date

Oct, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Pregnant individuals aged 18 years or older with indications of periodontal diseases (gingivitis or mild periodontitis, moderate to severe periodontitis)
2. Less than 20 weeks pregnancy at time of enrollment
3. Has dental insurance (Medi-Cal or private coverage)
4. Willing and able to provide informed consent
5. Planning to receive ongoing prenatal care at study-affiliated clinics
6. Access to a mobile phone for receiving text messages

Exclusion Criteria:

1. Presence of systemic diseases or medical conditions that require antibiotic prophylaxis for dental procedures
2. Current immunosuppressive therapy/use of anti-inflammatory medications
3. Receipt of active periodontal treatment within the past 6 months
4. Complete edentulism (no natural teeth)
5. Unable to read and write English
6. Less than 9th grade education
7. Enrollment in another oral interventional study

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Test

Enhanced Care + receive a home oral care kit (toothbrush, toothpaste, and floss), structured oral hygiene education, and behavioral reinforcement via weekly surveys

other: Control

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

Interventions

Enhanced Care

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

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 measure

  • Change in periodontal inflammation [ Time Frame: 28 weeks ]

Central Contacts and Locations

Central contacts

CHEER Study Manager

415-514-7900cheer@ucsf.edu

Locations

UCSF Dental Center

Recruiting

San Francisco, California, United States, 94143

Contacts

UCSF Dental Center

415-514-7900cheer@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.