Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women

NCT ID: NCT06868550

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-12
• Study Completion Date: 2026-03-15

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.

Conditions

Maternal and Child Health Outcomes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Comprehensive Oral Health Promotion Program

Intervention Type: BEHAVIORAL

The principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of them.

Comparator

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

Group Type: ACTIVE_COMPARATOR

Comprehensive Oral Health Promotion Program

Intervention Type: BEHAVIORAL

The principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of them.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sara Mohamed Zaki

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CU 26.2.2025

Identifier Type: -

Identifier Source: org_study_id