Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women

Not Applicable

Not yet recruiting

• Conditions: Maternal and Child Health Outcomes

• Registration Number: NCT06868550
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-26
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-04-12
• Primary Completion: 2026-01-31
• Study Completion: 2026-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Caries assessment	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.

Secondary Outcome Measures

Name	Time	Method
Oral Hygiene Assessment	Baseline, Week 12, and week 38	Participants' oral hygiene status will be assessed using the Simplified Oral Hygiene Index (OHI-S). The OHI-S score ranges from 0 To 6, where higher scores indicate worse oral hygiene due to increased plaque and debris accumlation.