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CenteringPregnancy Oral Health Promotion (CPOP)

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ClinicalTrials.gov Identifier: NCT04001933
Recruitment Status : Not yet recruiting
First Posted : June 28, 2019
Last Update Posted : January 19, 2021
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
University of California, San Francisco

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.

Condition or disease Intervention/treatment Phase
Oral Health Other: CPOP Intervention Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: CenteringPregnancy Oral Health Promotion (CPOP) Clinical Trial
Estimated Study Start Date : August 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

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.



Primary Outcome Measures :
  1. Change in percent of periodontal probing sites that bleed upon probing [ Time Frame: 12 weeks follow-up ]
    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.

  2. Change in percent of periodontal probing sites that probe at ≥4mm depth [ Time Frame: 12 weeks follow-up ]
    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.

  3. Change in plaque levels at 24 sites [ Time Frame: 12 weeks follow-up ]
    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.

  4. Incidence of salivary Mutans Streptococci in infants at 12 months of age [ Time Frame: 1-year follow-up postpartum ]
    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.


Secondary Outcome Measures :
  1. Change in maternal oral health knowledge [ Time Frame: 12 week follow-up ]
    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.

  2. Change in maternal oral health attitude [ Time Frame: 12 week follow-up ]
    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.

  3. Change in maternal oral health behavior [ Time Frame: 12 week follow-up ]
    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.

  4. Change in maternal knowledge regarding infant oral health [ Time Frame: 2 week follow-up ]
    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.

  5. Change in maternal attitude regarding infant oral health [ Time Frame: 2 week follow-up ]
    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.

  6. Incidence of salivary Lactobacillus in infants at 12 months of age [ Time Frame: 1 year follow-up postpartum ]
    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.

  7. Mediation outcomes for maternal oral health are maternal oral health knowledge [ Time Frame: 12 week follow-up ]
    Evaluation of maternal oral health knowledge as a mediator of the association between treatment arm and plaque, probing and bleeding.

  8. Mediation outcomes for maternal oral health are maternal oral health attitudes (importance and self-efficacy) [ Time Frame: 12 week follow-up ]
    Evaluation of maternal oral health attitudes as a mediator of the association between treatment arm and plaque, probing and bleeding.

  9. Mediation outcomes for maternal oral health are maternal oral health behaviors (ADA-recommended tooth brushing practices and flossing) [ Time Frame: 12 week follow-up ]
    Evaluation of maternal oral health behaviors as a mediator of the association between treatment arm and plaque, probing and bleeding.

  10. Mediation outcomes for infant oral health risk are infant oral health-related knowledge [ Time Frame: 1 year follow-up postpartum ]
    Evaluation of maternal knowledge of infant oral health as a mediator of the association between treatment arm and infant MS and LB.

  11. Mediation outcomes for infant oral health risk are infant oral health-related attitudes (importance and self-efficacy) [ Time Frame: 1 year follow-up postpartum ]
    Evaluation of maternal attitudes toward infant oral health as a mediator of the association between treatment arm and infant MS and LB.

  12. Mediation outcomes for infant oral health risk are infant oral health-related behaviors (importance and self-efficacy) [ Time Frame: 1 year follow-up postpartum ]
    Evaluation of maternal behaviors toward infant oral health as a mediator of the association between treatment arm and infant MS and LB.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04001933


Contacts
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Contact: Lisa Berens, DDS, MPH 415-476-2532 Lisa.Berens@ucsf.edu

Sponsors and Collaborators
University of California, San Francisco
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Lisa Berens, DDS, MPH University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04001933    
Other Study ID Numbers: 18-029-E
1U01DE027340-01 ( U.S. NIH Grant/Contract )
First Posted: June 28, 2019    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Pregnancy
Oral Health
Maternal Oral Health
Infant Oral Health