CenteringPregnancy Oral Health Promotion

NCT04001933 | Withdrawn DMC

• 2 other identifiers: 18-029-E1U01DE027340-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Oral Health

Keywords

Pregnancy; Oral Health; Maternal Oral Health; Infant Oral Health

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (12)

• Change in maternal oral health knowledge

  12 week follow-up

• Change in maternal oral health attitude

  12 week follow-up

• Change in maternal oral health behavior

  12 week follow-up

• Change in maternal knowledge regarding infant oral health

  2 week follow-up

• Change in maternal attitude regarding infant oral health

  2 week follow-up

Study Arms (2)

Intervention Arm

EXPERIMENTAL

CPOP Intervention (see below).

Other: CPOP Intervention

Control Arm

NO INTERVENTION

Usual care.

Interventions

CPOP Intervention OTHER

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.

Intervention Arm

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- none

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Officials

• Lisa Berens, DDS, MPH

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 28, 2019
• Study Start: August 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 31, 2022
• Last Updated: January 23, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share