CenteringPregnancy Oral Health Promotion (CPOP)

CenteringPregnancy Oral Health Promotion (CPOP) Clinical Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Oral Health
• Intervention / Treatment: Other: CPOP Intervention

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; CPOP Intervention (see below).	Other: CPOP Intervention; The intervention consists of two 15-minute interactive modules (maternal and infant OH), integrated into 2 group prenatal care sessions. Led by trained prenatal care providers (facilitators), the maternal module includes discussion of common OH problems during pregnancy, importance of OH, importance and safety of OH care during pregnancy, hands-on skills-building activities of learning and practicing proper tooth brushing and self-assessment of gum health, and presentation of illustrated flossing and OH promotion guides. The infant module includes discussion of infant oral hygiene, avoiding saliva sharing, proper nutrition, and importance of a dental visit by the first birthday. Activities in both modules utilize separate tool kits including tooth brushes, fluoride toothpaste, and other supplies.
No Intervention: Control Arm; Usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in percent of periodontal probing sites that bleed upon probing	Based on clinical dental exams conducted before the maternal oral health module and approximately 12 weeks following the maternal module, comparisons between the Intervention and Control groups will be conducted to determine differences in change in the percent of periodontal probing sites that bleed upon probing.	12 weeks follow-up
Change in percent of periodontal probing sites that probe at ≥4mm depth	Based on clinical dental exams conducted before the maternal oral health module and approximately 12 weeks following the maternal module, comparisons between the Intervention and Control groups will be conducted to determine differences in change in the percent of periodontal probing sites that probe at ≥4mm depth.	12 weeks follow-up
Change in plaque levels at 24 sites	Based on clinical dental exams conducted before the maternal oral health module and approximately 12 weeks following the maternal module, comparisons between the Intervention and Control groups will be conducted to determine differences in change in plaque levels at 24 sites (4 sites on 6 teeth) using the Plaque Index. Each site is scored from 0-3 (0=no plaque; 3=heavy plaque), yielding a score between 0 and 72.	12 weeks follow-up
Incidence of salivary Mutans Streptococci in infants at 12 months of age	Based on results of assays of infant saliva specimens collected at 12 months of age, comparisons between infants whose mothers were in the Intervention versus the Control groups will be conducted to determine differences in the incidence of Mutans Streptococci.	1-year follow-up postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maternal oral health knowledge	Self reported oral health knowledge questionnaire which includes 12 dichotomous items (0-1) for a total between 0 and 12 used for comparisons between the Intervention and Control groups.	12 week follow-up
Change in maternal oral health attitude	Self reported oral health attitude questionnaire which includes 8 items scored 1-4 (1=Not at all important; 4=Very important) for a total between 8 and 32 used for comparisons between the Intervention and Control groups.	12 week follow-up
Change in maternal oral health behavior	Self reported oral health behavior questionnaire which includes 4 items scored as either correct or incorrect (0=Incorrect; 1=Correct) for a total between 0-4 used for comparisons between the Intervention and Control groups.	12 week follow-up
Change in maternal knowledge regarding infant oral health	Self reported infant oral health knowledge questionnaire which includes 10 dichotomous items (0-1) for a total between 0 and 10 used for comparisons between the Intervention and Control groups.	2 week follow-up
Change in maternal attitude regarding infant oral health	Self reported infant oral health attitude questionnaire which includes 8 items scored 1-4 (1=Not at all important; 4=Very important) for a total between 8 and 32 used for comparisons between the Intervention and Control groups.	2 week follow-up
Incidence of salivary Lactobacillus in infants at 12 months of age	Based on results of assays of infant saliva specimens collected at 12 months of age, comparisons between infants whose mothers were in the Intervention versus the Control groups will be conducted to determine differences in the incidence of Lactobacillus.	1 year follow-up postpartum
Mediation outcomes for maternal oral health are maternal oral health knowledge	Evaluation of maternal oral health knowledge as a mediator of the association between treatment arm and plaque, probing and bleeding.	12 week follow-up
Mediation outcomes for maternal oral health are maternal oral health attitudes (importance and self-efficacy)	Evaluation of maternal oral health attitudes as a mediator of the association between treatment arm and plaque, probing and bleeding.	12 week follow-up
Mediation outcomes for maternal oral health are maternal oral health behaviors (ADA-recommended tooth brushing practices and flossing)	Evaluation of maternal oral health behaviors as a mediator of the association between treatment arm and plaque, probing and bleeding.	12 week follow-up
Mediation outcomes for infant oral health risk are infant oral health-related knowledge	Evaluation of maternal knowledge of infant oral health as a mediator of the association between treatment arm and infant MS and LB.	1 year follow-up postpartum
Mediation outcomes for infant oral health risk are infant oral health-related attitudes (importance and self-efficacy)	Evaluation of maternal attitudes toward infant oral health as a mediator of the association between treatment arm and infant MS and LB.	1 year follow-up postpartum
Mediation outcomes for infant oral health risk are infant oral health-related behaviors (importance and self-efficacy)	Evaluation of maternal behaviors toward infant oral health as a mediator of the association between treatment arm and infant MS and LB.	1 year follow-up postpartum

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
• Investigators: Principal Investigator: Lisa Berens, DDS, MPH, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: June 4, 2019
• First Submitted That Met QC Criteria: June 26, 2019
• First Posted (Actual): June 28, 2019

Study Record Updates

• Last Update Posted (Actual): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Pregnancy; Oral Health; Maternal Oral Health; Infant Oral Health
• Other Study ID Numbers: 18-029-E; 1U01DE027340-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No