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临床试验/NCT06868550
NCT06868550尚未招募不适用

Impact of a Comprehensive Oral Health Promotion Program on Maternal Oral Health, Knowledge, Attitudes, and Practices Versus Standard Care in a Group of Egyptian Pregnant Women: a Randomized Controlled Trial

Cairo University0 个研究点目标入组 58 人开始时间: 2025年4月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
58
主要终点
Caries assessment

研究概览

简要总结

The research question: In pregnant women, does participation in a comprehensive oral health promotion program, compared to standard care, improve maternal oral health, knowledge, attitudes, and practices? This study aims to evaluate the impact of a comprehensive oral health promotion program, compared to standard care, on improving maternal oral health, knowledge, attitudes, and practices among pregnant women. Null hypothesis: There is no significant difference in maternal oral health, knowledge, attitudes, and practices between the group of Egyptian pregnant women who receive the comprehensive oral health promotion program and those who receive standard care. The study population will be pregnant women aged 20 to 45 years. The participants will be categorized into two groups: Intervention will be offered Comprehensive Program and will Include educational workshops, Videos, pamphlets, and support sessions and group chat; and Comparator group will receive Standard care (Limited to oral health sessions only). The study will evaluate three outcomes. Primary outcome The participants will undergo a caries assessment test using The DMFT Index. Secondary outcome The Oral Hygiene Assessment will include the participants using the Simplified Oral Hygiene Index (OHI-S).

Tertiary outcome

  1. The knowledge, attitude, and practice (KAP) assessment for pregnant women regarding the Comprehensive Oral Health Promotion Program will be carried out through a prestructured questionnaire. The response data will be collected as frequency and percentage.
  2. The nutritional assessment for all participants will be performed using a prestructured questionnaire. The response data will be recorded as frequency and percentage.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
21 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Mothers willing to participate.
  • •Pregnant women from 20 to 45 years
  • •Participants can understand and communicate

排除标准

  • •Pre-existing systemic conditions such as diabetes or cardiovascular diseases.
  • •Participants with a high risk of non-compliance with study requirements

研究组 & 干预措施

Intervention

Experimental

Behavioral: Comprehensive oral health program: participants will receive structured oral health education through workshops, videos, pamphlets, and interactive support sessions

干预措施: Comprehensive Oral Health Promotion Program (Behavioral)

Comparator

Active Comparator

Behavioral: Standard oral health care: participants will receive routine oral health education in standard care sessions without additional educational materials or interactive support

干预措施: Comprehensive Oral Health Promotion Program (Behavioral)

结局指标

主要结局

Caries assessment

时间窗: Baseline, 38 weeks

Participants will undergo a caries assessment test using the Decayed, Missing, and Filled Teeth (DMFT) index. The DMFT index ranges from 0 to 28 (or 32, depending on the number of teeth present). Higher scores indicate worse oral health, as they reflect more decayed, missing, or filled teeth.

次要结局

  • Oral Hygiene Assessment(Baseline, Week 12, and week 38)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Mohamed Zaki

Principal Investigator

Cairo University

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