Clinical trial NCT04001933: CenteringPregnancy Oral Health Promotion
Official title: CenteringPregnancy Oral Health Promotion (CPOP) Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Oral Health
Keywords: Pregnancy
Oral Health
Maternal Oral Health
Infant Oral Health
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
First posted: 2019-06-28
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A five-year, Phase III, multi-site, cluster randomized controlled clinical trial will evaluate the efficacy of the CenteringPregnancy (CP) Oral Health Promotion (CPOP) intervention. Intervention and control groups will be drawn from 6 CP sites. Prenatal care facilitators will conduct the intervention in group prenatal care sessions. With an average of 4 CP facilitators per site (24 facilitators), conducting 2-3 CP groups each (48-72 CP groups with 8 mother/child dyads per group), the total study population will be approximately 384 dyads. CP facilitators will be randomly assigned to either the: 1) intervention arm and deliver the CPOP intervention; or 2) control arm and deliver the usual CP curriculum. The CPOP intervention consists of two 15-minute modules: 1) maternal oral health (OH) and 2) infant OH. The data collection will continue through 12 months postpartum. For the maternal OH module, pre- and post-intervention dental exams of gingival OH and Plaque Levels, and knowledge, attitudes and behavior (KAB) questionnaires during the prenatal period will be used to assess maternal OH outcomes. For the infant OH module, pre and post-module KAB questionnaires will be completed during the prenatal period. Infant OH risk status - the presence of caries-causing bacteria (mutans streptococci and Lactobacilli) in saliva of both mother and infant will be assessed when the infant is 12 months of age to determine differences in study arms.


Eligibility criteria: Inclusion Criteria:

Women:

* speak, read, or write in English or Spanish
* enrolled in CP prenatal group care identified as study group
* free of any condition that requires them to take antibiotic or antibacterial medication prior to dental procedures
* provide informed consent

Babies:

* healthy with no acute or chronic medical conditions, especially those conditions that may have resulted in hospitalizations and subsequent exposure to pathologic microorganisms
* free of any condition requiring antibiotic treatment currently or within the past three months.
* mothers provide informed consent for their children at baseline

Exclusion Criteria:

- none

Primary outcomes:
measure: Change in percent of periodontal probing sites that bleed upon probing
timeFrame: 12 weeks follow-up
measure: Change in percent of periodontal probing sites that probe at ≥4mm depth
timeFrame: 12 weeks follow-up
measure: Change in plaque levels at 24 sites
timeFrame: 12 weeks follow-up
measure: Incidence of salivary Mutans Streptococci in infants at 12 months of age
timeFrame: 1-year follow-up postpartum
Secondary outcomes:
measure: Change in maternal oral health knowledge
timeFrame: 12 week follow-up
measure: Change in maternal oral health attitude
timeFrame: 12 week follow-up
measure: Change in maternal oral health behavior
timeFrame: 12 week follow-up
measure: Change in maternal knowledge regarding infant oral health
timeFrame: 2 week follow-up
measure: Change in maternal attitude regarding infant oral health
timeFrame: 2 week follow-up
measure: Incidence of salivary Lactobacillus in infants at 12 months of age
timeFrame: 1 year follow-up postpartum
measure: Mediation outcomes for maternal oral health are maternal oral health knowledge
timeFrame: 12 week follow-up
measure: Mediation outcomes for maternal oral health are maternal oral health attitudes (importance and self-efficacy)
timeFrame: 12 week follow-up
measure: Mediation outcomes for maternal oral health are maternal oral health behaviors (ADA-recommended tooth brushing practices and flossing)
timeFrame: 12 week follow-up
measure: Mediation outcomes for infant oral health risk are infant oral health-related knowledge
timeFrame: 1 year follow-up postpartum
measure: Mediation outcomes for infant oral health risk are infant oral health-related attitudes (importance and self-efficacy)
timeFrame: 1 year follow-up postpartum
measure: Mediation outcomes for infant oral health risk are infant oral health-related behaviors (importance and self-efficacy)
timeFrame: 1 year follow-up postpartum
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Lisa Berens, DDS, MPH
role: PRINCIPAL_INVESTIGATOR
References: