The effect of oral health education on children’s oral hygiene and mothers’ knowledge, attitudes, and practices
| ISRCTN | ISRCTN71415867 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71415867 |
- Submission date
- 18/10/2024
- Registration date
- 23/10/2024
- Last edited
- 04/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims:
Good oral health is vital for children’s overall well-being, as it affects their ability to eat, speak, and grow properly. In Saudi Arabia, many children suffer from dental issues like tooth decay, with 96% affected by dental caries. Educating young children and their families about oral health can help reduce these problems. This study aims to compare two types of oral health education: conventional methods, such as presentations, and non-conventional methods, like interactive storytelling and games. We want to see which approach better improves children’s oral hygiene and mothers’ knowledge, attitudes, and practices about their children’s dental care.
Who can participate?
Children aged 5-6 years old who are enrolled in kindergartens in Al-Ahsa, Saudi Arabia, along with their mothers, are eligible to participate in this study.
What does the study involve?
Participants will be divided into two groups. One group will receive conventional oral health education through a single presentation, while the other group will receive non-conventional education using interactive methods, including games and storytelling, over several sessions. Both groups of children will have their oral hygiene status assessed by a dentist before and after the program. Mothers will also complete questionnaires to assess their knowledge, attitudes, and practices about their children’s oral hygiene before and after the education sessions.
What are the possible benefits and risks of participating?
Children and mothers may benefit from improved oral health knowledge and practices, leading to better dental care for children. There are no significant risks associated with participating, as the educational sessions and dental check-ups are safe and non-invasive.
Where is the study run from?
The study will be conducted in public and private kindergartens across Al-Ahsa, Saudi Arabia.
When is the study starting and how long is it expected to run for?
September 2023 to March 2025.
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Hajar Ibrahim Alsuwayi, Hajar.i.alsuwayi@gmail.com
Contact information
Public, Scientific, Principal Investigator
Aramco Mahasin District 1
Al Mubarraz
Al-Ahsa
36422
Saudi Arabia
 ORCID ID |
0009-0001-2376-9993 |
|---|---|
| Phone | +966 509202221 |
| 223000702@student.kfu.edu.sa |
Study information
| Study design | Double arm single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Childcare/pre-school |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | The effect of an oral health education program on kindergarten children’s oral hygiene and mothers’ knowledge, attitudes, and practices: a randomized controlled trial |
| Study acronym | OECKAP-RCT |
| Study objectives | Non-conventional oral health education can improve the oral hygiene status of preschool children, and mothers' oral hygiene knowledge, attitudes, and practices towards their children more than the conventional programs. |
| Ethics approval(s) |
Approved 06/03/2024, Research Ethics Committee at King Faisal University (King Faisal University P.O. Box 400, Al-Ahsa, 31982, Saudi Arabia; +966 15899773; ialjreesh@kfu.edu.sa), ref: KFU-REC-2024-MAR-ETHICS2027 |
| Health condition(s) or problem(s) studied | Improving oral hygiene and health behaviors in kindergarten children and their mothers through oral health education. |
| Intervention | This study involves a randomized controlled trial designed to assess the effectiveness of an oral health education program on improving oral hygiene in kindergarten children and enhancing mothers’ knowledge, attitudes, and practices (KAP) regarding their children’s oral health. The intervention consists of 4 visits to kindergarten schools in Al-Ahsa province, where the children participate in engaging activities, including storytelling, games, and interactive sessions focused on oral health education. The mothers will attend an educational lecture on children’s oral hygiene, which will cover essential topics such as proper brushing techniques, dietary influences on oral health, and the importance of regular dental check-ups. Participants will be randomly assigned to either the intervention group, which receives the oral health education program, or the control group, which receives conventional education on oral health. Randomization will be conducted using a computer-generated randomization sequence to ensure unbiased assignment. The oral hygiene status of the children will be measured using the Simplified Oral Hygiene Index before and after the program, while the KAP of mothers will be assessed through questionnaires administered before and after the educational lecture. |
| Intervention type | Behavioural |
| Primary outcome measure | Oral hygiene status is measured using the Simplified Oral Hygiene Index (OHI-S) at baseline and after the completion of the oral health education program |
| Secondary outcome measures | Mothers’ knowledge, attitudes, and practices (KAP) regarding children’s oral health are measured using a structured questionnaire at baseline before the educational lecture and at follow-up assessment 3 months after the educational lecture |
| Overall study start date | 11/09/2023 |
| Completion date | 30/03/2025 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Lower age limit | 5 Years |
| Upper age limit | 50 Years |
| Sex | Both |
| Target number of participants | Target recruitment is 1732 participants, consisting of 866 children aged 5-6 years and 866 mothers. |
| Total final enrolment | 1400 |
| Key inclusion criteria | 1. Children aged 5-6 years who are registered in the respective academic year at kindergarten schools in Al-Ahsa. 2. Mothers of preschool children who agree to participate and provide consent. 3. Children and mothers who can attend all educational sessions. |
| Key exclusion criteria | 1. Special needs kindergartens. 2. Illiterate mothers. 3. Children with dental anomalies. 4. Children with orthodontic appliances. 5. Children with systemic conditions such as Diabetes mellitus, Hemophilia, Cancer, Craniofacial anomalies, or syndromes. |
| Date of first enrolment | 25/08/2024 |
| Date of final enrolment | 25/10/2024 |
Locations
Countries of recruitment
- Saudi Arabia
Study participating centres
Al Shehabiyah
Al Hofuf
Al-Ahsa province
36365
Saudi Arabia
6700, 4933
Al Hofuf and Al Mubarraz
Al-Ahsa province
36361
Saudi Arabia
2796, 9269
Al Omairiyah
Al Hufuf and Al Mubarraz
Al-Ahsa province
36362
Saudi Arabia
Next to the train station
Prince Saud Bin Jalawi Rd
Al Hofuf
Al-Ahsa province
36361
Saudi Arabia
8HMF+GG3, Othman Bin Affan St
Al Aziziyah, Al Hofuf
Al-Ahsa province
36442
Saudi Arabia
87, Al-Rashidiya
Al-Hofuf and Al-Mubarraz
Al-Ahsa province
36342
Saudi Arabia
8505 Ain Najm Road
Al Qadisiyah
Al Hufuf and Al Mubarraz
Al-Ahsa province
36422
Saudi Arabia
CH9Q+7MP, Madinatal Mubarraz
Al Mubarraz
Al-Ahsa province
36341
Saudi Arabia
5440, Al Qadisiyah
Al Qadisiyyah
Al Hufuf and Al Mubarraz
Al-Ahsa province
36423
Saudi Arabia
Sponsor information
Other
P.O. Box 400
Al-Ahsa
31982
Saudi Arabia
| Phone | +966 15899773 |
|---|---|
| ialjreesh@kfu.edu.sa | |
| Website | https://www.kfu.edu.sa/en/Deans/Research/Pages/Home-new.aspx |
"ROR" |
https://ror.org/00dn43547 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 30/08/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Results from this study will be prepared for publication in a peer-reviewed journal specializing in dental public health or pediatric dentistry. Additionally, the findings will be presented at relevant dental conferences and shared with participating kindergartens and healthcare professionals in Al-Ahsa to help inform future oral health education programs. |
| IPD sharing plan | The datasets generated during the current study will be available upon request from Hajar Alsuwayi, the principal investigator, at Hajar.i.alsuwayi@gmail.com. The type of data that will be shared includes individual-level data on children’s oral hygiene status, as measured by the simplified oral hygiene index, and mothers’ responses to questionnaires regarding their knowledge, attitudes, and practices related to their children’s dental care. Data will become available after the study is completed and the results are published, expected by mid-2026. The data will be shared for a duration of five years following publication. Access to the data will be granted to researchers and healthcare professionals interested in conducting secondary analyses relevant to oral health education and pediatric dentistry. All requests for data will be evaluated on a case-by-case basis. Consent from participants has been obtained for the use of their anonymized data in research. Data will be anonymized to protect participant identities, and any identifying information will be removed prior to sharing. Ethical considerations have been addressed in accordance with the guidelines set forth by the Research Ethics Committee at King Faisal University. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 23/10/2024 | No | No | ||
| Basic results | 04/06/2025 | No | No | ||
| Dataset | SPSS sav file | 04/06/2025 | No | No | |
| Statistical Analysis Plan | 04/06/2025 | No | No |
Additional files
Editorial Notes
04/06/2025: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The basic results have been uploaded as an additional file.
3. A dataset was uploaded as an additional file.
21/10/2024: Trial's existence confirmed by Research Ethics Committee at King Faisal University.
