Oral Health Promotion Vs. Standard Care in Egyptian Pregnant Women

NCT06868550 | Not Yet Recruiting DMC

• 1 other identifier: CU 26.2.2025
• Study Type: interventional
• Target: 58
• Locations: 0 countries
• Sites: N/A

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. 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. 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

Outcome Measures

Primary Outcomes (1)

• Caries assessment

  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.

  Baseline, 38 weeks

Secondary Outcomes (1)

• Oral Hygiene Assessment

  Baseline, Week 12, and week 38

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Comprehensive Oral Health Promotion Program

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

Behavioral: Comprehensive Oral Health Promotion Program

Interventions

Comprehensive Oral Health Promotion Program BEHAVIORAL

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

Comparator; Intervention

Eligibility Criteria

• Age: 21 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 11, 2025
• Study Start: April 12, 2025
• Primary Completion: January 31, 2026
• Study Completion: March 15, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share