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Not yet recruiting NCT06868550

Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women

No phase Interventional Maternal and Child Health Outcomes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Oral Health Promotion Program.
Who it may be relevant to
Registry conditions: Maternal and Child Health Outcomes. Basic parameters: 21 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral Comprehensive Oral Health Promotion Program
    The principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of them.

Primary outcome measures

  • Caries assessment [Time frame: Baseline, 38 weeks]
Secondary outcome measures (1)
  • Oral Hygiene Assessment [Time frame: Baseline, Week 12, and week 38]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06868550 · CU 26.2.2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗