Oral HealthCPOPNCT04001933
CenteringPregnancy Oral Health Promotion
A study testing CPOP Intervention in people with Oral Health, run by University of California, San Francisco.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- CPOP Intervention
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2020to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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
Who cannot join
- none
About this study
Official title: 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.
- Conditions
- Oral Health
- Being tested
- CPOP Intervention
- Keywords
- Pregnancy, Oral Health, Maternal Oral Health, Infant Oral Health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPOP InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | CPOP Intervention (see below). Receives: Other: CPOP Intervention |
| Control Arm | No intervention | Usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1-year follow-up postpartum
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year follow-up postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2019
- Study startAug 2020 (estimated)
- Primary completionJul 2022 (estimated)
- Study completion31 Jul 2022
Why it stopped: The onset of COVID-19 shut down San Francisco in March 2020, resulting in immediate suspension of group prenatal care at our clinic sites. This continued suspension prevented the conduct of study activities, which resulted in study termination.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
- Investigators
- Lisa Berens, DDS, MPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001933
- Sponsor's protocol ID
- 18-029-E
- Other IDs
- 1U01DE027340-01
- Acronym
- CPOP
- Status last verified
- Jan 2023
- First submitted
- 4 Jun 2019
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CenteringPregnancy Oral Health Promotion (CPOP) Clinical Trial
- ClinicalTrials.gov ID
- NCT04001933
- Acronym / sponsor ID
- CPOP / 18-029-E
- Conditions
- Oral Health
- Keywords
- Pregnancy, Oral Health, Maternal Oral Health, Infant Oral Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The onset of COVID-19 shut down San Francisco in March 2020, resulting in immediate suspension of group prenatal care at our clinic sites. This continued suspension prevented the conduct of study activities, which resulted in study termination.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Aug 2020 (estimated)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 28 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: CPOP InterventionCPOP Intervention (see below). |
| Control Arm | No intervention | –Usual care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- healthy with no acute or chronic medical conditions, especially those conditions that may have resulted in hospitalizations and subsequent exposure to pathologic microorganisms
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPOP InterventionThe 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. | Other | Intervention Arm |
Primary outcome
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.
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.
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.
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.
12 secondary outcomes
Change in maternal oral health knowledge
Time frame: 12 week follow-up
Change in maternal oral health attitude
Time frame: 12 week follow-up
Change in maternal oral health behavior
Time frame: 12 week follow-up
Change in maternal knowledge regarding infant oral health
Time frame: 2 week follow-up
Change in maternal attitude regarding infant oral health
Time frame: 2 week follow-up
Incidence of salivary Lactobacillus in infants at 12 months of age
Time frame: 1 year follow-up postpartum
Mediation outcomes for maternal oral health are maternal oral health knowledge
Time frame: 12 week follow-up
Mediation outcomes for maternal oral health are maternal oral health attitudes (importance and self-efficacy)
Time frame: 12 week follow-up
Mediation outcomes for maternal oral health are maternal oral health behaviors (ADA-recommended tooth brushing practices and flossing)
Time frame: 12 week follow-up
Mediation outcomes for infant oral health risk are infant oral health-related knowledge
Time frame: 1 year follow-up postpartum
Mediation outcomes for infant oral health risk are infant oral health-related attitudes (importance and self-efficacy)
Time frame: 1 year follow-up postpartum
Mediation outcomes for infant oral health risk are infant oral health-related behaviors (importance and self-efficacy)
Time frame: 1 year follow-up postpartum
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Oral Health
Active, not recruiting
Alveolar Ridge Reconstruction in Post-extraction Sites Using a Magnesium Resorbable Membrane. An Explorative Study
Bone Augmentation, Alveolar Ridge Augmentation
RecruitingPhase 4
Oral Azacitidine in Transplant-Eligible Patients With Acute Myeloid Leukemia (AML) Suffering From Health-Inequality
Acute Myeloid Leukemia
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Not yet recruiting
Manus AI-Assisted Orthodontic Education and Oral Health-Related Quality of Life
Oral Health-Related Quality of Life
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Berens, DDS, MPH principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing CPOP Intervention in people with Oral Health, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in percent of periodontal probing sites that bleed upon probing (time frame: 12 weeks follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.