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Набор скоро начнётся NCT07377344

CHEER Oral Health in Pregnancy Study

Без фазы С лечением Gingivitis Dental Health Pregnancy Pregnancy Outcomes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Enhanced Care, Enhanced Care +.
Кому может быть актуально
Состояния в реестре: Gingivitis, Dental Health, Pregnancy, Pregnancy Outcomes. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Closing Health Equity Through Empowering Oral Health for Maternal Wellness

Обзор

Many pregnant people don't get the dental care they need, even though it's safe and important. The CHEER Study offers free dental check-ups, cleanings, and supplies to help participants take care of their teeth and gums during pregnancy. The purpose of this research study is to compare two types of noninvasive oral health interventions to evaluate their effectiveness. We want to learn if one method is more effective in supporting oral health and improving pregnancy outcomes. There are two aims of this study: Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease. Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.

Подробное описание

The Closing Health Equity through Empowering Oral Health for Maternal Wellness (the CHEER Oral Health in Pregnancy Study) aims to address significant oral health disparities experienced by pregnant individuals, particularly those from low-income and minority communities in California.

Oral health is a critical yet often overlooked component of prenatal care. Existing evidence suggests that periodontal disease is associated with adverse pregnancy outcomes, such as preterm birth and low birth weight. However, many pregnant individuals in California do not receive adequate oral health services, especially those from historically marginalized communities. The CHEER Project aims to address this gap by implementing an intervention that is scalable, community-engaged, and grounded in evidence-based education.

This study will generate novel data on the impact of oral health education and behavior modification, delivered through accessible messaging and product use, on periodontal inflammation and disease status, and microbiome profiles. It will also explore potential downstream effects on perinatal outcomes. The study aligns with public health priorities to improve maternal wellness, health equity, and the integration of dental and medical care.

There are two study aims:

Aim 1: To evaluate whether a structured oral health intervention reduces periodontal inflammation during pregnancy and postpartum in pregnant people with indicators of periodontal disease.

Aim 2: To assess whether a structured oral health intervention is associated with changes in oral health behaviors or birth outcomes in pregnant people with periodontal disease.

Вмешательства

  • Поведенческое Enhanced Care
    All participants receive standard oral hygiene education at the baseline visit.
  • Поведенческое Enhanced Care +
    All participants receive standard oral hygiene education at the baseline visit. Test participants also receive a home oral care kit (toothbrush, toothpaste, and floss), and will start receiving weekly oral health check-ins and reminder surveys following their initial visits at one-week intervals starting the day after their baseline visit

Первичные конечные точки

  • Change in periodontal inflammation [Срок оценки: 28 weeks]
Вторичные конечные точки (1)
  • Changes in oral health behaviors [Срок оценки: 28 weeks]

Критерии участия

Критерии включения

  • Pregnant individuals aged 18 years or older with indications of periodontal diseases (gingivitis or mild periodontitis, moderate to severe periodontitis)
  • Less than 20 weeks pregnancy at time of enrollment
  • Has dental insurance (Medi-Cal or private coverage)
  • Willing and able to provide informed consent
  • Planning to receive ongoing prenatal care at study-affiliated clinics
  • Access to a mobile phone for receiving text messages

Критерии исключения

  • Presence of systemic diseases or medical conditions that require antibiotic prophylaxis for dental procedures
  • Current immunosuppressive therapy/use of anti-inflammatory medications
  • Receipt of active periodontal treatment within the past 6 months
  • Complete edentulism (no natural teeth)
  • Unable to read and write English
  • Less than 9th grade education
  • Enrollment in another oral interventional study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • UCSF Dental Center — San Francisco

Идентификаторы

NCT: NCT07377344 · 20254330

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗