Maternal and Child Health OutcomesNCT06868550
Oral Health Promotion vs. Standard Care in Egyptian Pregnant Women
A study testing Comprehensive Oral Health Promotion Program in people with Maternal and Child Health Outcomes, run by Cairo University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal and Child Health Outcomes
- What is being tested?
- Comprehensive Oral Health Promotion Program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2025to 15 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mothers willing to participate.
- Pregnant women from 20 to 45 years
- Participants can understand and communicate
Who cannot join
- Pre-existing systemic conditions such as diabetes or cardiovascular diseases.
- Participants with a high risk of non-compliance with study requirements
Trial locations and contacts
1 site in 1 country.
Egypt1 site
El-Shorouk Family Health Center (100 m Center)
Cairo, Cairo Governorate, 11837
About this study
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
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
- 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.
- 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
- Being tested
- Comprehensive Oral Health Promotion Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Oral Health Promotion ProgramBehavioural
The principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of them.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral: Comprehensive oral health program: participants will receive structured oral health education through workshops, videos, pamphlets, and interactive support sessions Receives: 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 Receives: Behavioral: Comprehensive Oral Health Promotion Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 38 weeks
Secondary outcomes (1)
Oral Hygiene Assessment
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.
Measured: Baseline, Week 12, and week 38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start12 Apr 2025
- Primary completion31 Jan 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal and Child Health OutcomesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mohamed Zaki, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868550
- Sponsor's protocol ID
- CU 26.2.2025
- Status last verified
- Mar 2025
- First submitted
- 26 Feb 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The collected data will not be shared publicly due to confidentiality policies and ethical restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06868550
- Acronym / sponsor ID
- CU 26.2.2025
- Conditions
- Maternal and Child Health Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Apr 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- The nutritional assessment for all participants will be performed using a prestructured questionnaire. The response data will be recorded as frequency and percentage.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Comprehensive Oral Health Promotion ProgramBehavioral: Comprehensive oral health program: participants will receive structured oral health education through workshops, videos, pamphlets, and interactive support sessions |
| Comparator | Active comparator | Behavioral: Comprehensive Oral Health Promotion ProgramBehavioral: Standard oral health care: participants will receive routine oral health education in standard care sessions without additional educational materials or interactive support |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Mothers willing to participate.
- Pregnant women from 20 to 45 years
- Participants can understand and communicate
Key exclusion criteria (2 listed)
- Pre-existing systemic conditions such as diabetes or cardiovascular diseases.
- Participants with a high risk of non-compliance with study requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Oral Health Promotion ProgramThe principal investigator will carry out all treatment procedures, and the patients will be randomly assigned to any of them. | Behavioural | Comparator, Intervention |
Primary outcome
Caries assessment
Time frame: 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.
1 secondary outcome
Oral Hygiene Assessment
Time frame: Baseline, Week 12, and week 38
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No. The collected data will not be shared publicly due to confidentiality policies and ethical restrictions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Oral Health Promotion Program in people with Maternal and Child Health Outcomes, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries assessment (time frame: Baseline, 38 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.