CHEER Oral Health in Pregnancy Study

NCT07377344 | Not Yet Recruiting

• 1 other identifier: 20254330
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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; Periodontal Disease; Gum Disease

Outcome Measures

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.

  28 weeks

Secondary Outcomes (2)

• Changes in oral health behaviors

  28 weeks

• Difference in birth outcomes between test and control groups

  28 weeks

Study Arms (2)

Test

EXPERIMENTAL

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

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

Behavioral: Enhanced Care

Interventions

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

Test

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colgate Palmolive: collaborator
• University of California, San Francisco: lead

Study Sites (1)

UCSF Dental Center

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Gingivitis; Periodontal Diseases; Gingival Diseases

Condition Hierarchy (Ancestors)

Infections; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Effie Ioannidou, DDS, MDS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Laura Jelliffe-Pawlowski, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CHEER Study Manager

CONTACT

415-514-7900; cheer@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 29, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 29, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)