Dental Caries in ChildrenNCT07009015
Impact of Oral Health Program on Al-Lith Children's KAP
A study testing The oral health education intervention program in people with Dental Caries in Children, run by Universiti Putra Malaysia at 1 site in Malaysia.
Trial summary
Dental caries remains a significant global public health issue, particularly affecting children's health, development, and well-being, with inadequate knowledge, attitudes, and practices around oral health exacerbating these impacts. Read more about this study
- Who is it for?
- Ages 10 to 11 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- The oral health education intervention program
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 430 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2024to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 to 11 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary school male students.
- Aged 10 to 11 years old.
- Students who have at least one of their parent's consents to participate in the study.
Who cannot join
- Students who are medically ill at the time of conducting the study.
- Students that are absent while conducting the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Universiti Putra Malaysia
Serdang, Selangor, 43300
Ahmad Iqmer Nashriq Mohd Nazan, PhD, +603-9769 2941, iqmernashriq@upm.edu.my
Mohammed Alsharif, Master, +60145690140, mksharef@gmail.com
About this study
Official title: The Effect Of Health Education Intervention Program In Improving Knowledge, Attitude, And Practice Of Oral Health Among Male Primary School Children In Al-Lith Saudi Arabia: A Clustered Randomised Control Trial
Dental caries remains a significant global public health issue, particularly affecting children's health, development, and well-being, with inadequate knowledge, attitudes, and practices around oral health exacerbating these impacts. To address this, a cluster randomized controlled trial will be conducted in four primary schools in Al Lith City, Saudi Arabia, targeting children aged 10 to 11 years. The intervention involves interactive, classroom-based educational sessions led by a dental care professional, supplemented by take-home materials, focusing first on enhancing knowledge and attitudes, and then on developing behavioral skills for improved oral hygiene and eating habits. Participants' knowledge, attitudes, and practices will be assessed via questionnaires before, immediately after, and six months post-intervention, with data analyzed using SPSS through descriptive statistics, chi-square tests, One Way-ANOVA, and Generalized Estimating Equations. The study expects that school-based oral health education will significantly improve children's oral health knowledge and certain hygiene behaviors, as well as positively influence eating habits and patterns.
Read the detailed description
Background: Dental caries is a global public health concern and impacts children's health. Good oral health status at a young age is essential for children's development, general health, and well-being. Therefore, a lack of knowledge, attitude, and practice on oral health will affect children's development, overall health, and well-being. This study aims to evaluate a brief oral health intervention in schools by a primary dental care practitioner in improving the knowledge, practice, and attitude toward oral health care among primary school children in Al Lith City, Saudi Arabia. A cluster randomized controlled trial (CRCT) will be conducted in four schools in Al Lith City, Saudi Arabia, among children aged 10 to 11 years old. Methods: 160 children will receive classroom-based interactive educational sessions delivered by a dental care professional and receive take-home literature on oral health. The first session will focus on developing the participant's knowledge and attitude toward oral health. In contrast, the second session will cover topics on behavioural skills improvement to apply the knowledge and skills gained from the first session to improve their targeted behaviours of oral hygiene and eating habits. All children will complete a questionnaire on oral health knowledge, attitude, and practice before, immediately after, and six months following the intervention. Data will be analyzed using SPSS. Data will be presented by descriptive statistics. Chi-square test will be used to determine the association between the variables of the study. One Way-ANOVA will determine the mean differences for the selected variables. A generalized Estimating Equations (GEE) will be used to test the effect of the oral health education program on the outcomes between and within the groups. Expected Results: School-based preventative oral health education delivered by primary dental care practices can improve children's knowledge of oral health and some aspects of oral hygiene behaviour. There are significant differences will be detected in eating habits and eating patterns.
- Conditions
- Dental Caries in Children
- Being tested
- The oral health education intervention program
- Keywords
- Dental caries, Oral health status, Knowledge, Attitude, Practice
- Medical subject headings
- Dental Caries, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The oral health education intervention programOther
The intervention program will be designed to improve oral health knowledge, attitudes, and behaviors among students over a one-month school term, carefully scheduled to avoid disrupting regular academic activities. The program consists of initial sessions focused on building students' understanding and appreciation of oral health and healthy eating habits, followed by sessions aimed at developing practical behavioral skills. The effectiveness of the program will be evaluated at three points-before the intervention, two months after, and four months post-intervention-using a closed-ended questionnaire to assess changes in knowledge, attitudes, and practices.
| Study group | Role | What they receive |
|---|---|---|
| The oral health education intervention program | Other | The intervention program aims to enhance students' oral health knowledge, attitudes, and behaviors over a one-month school term through educational and practical sessions, with its effectiveness assessed before and after the intervention using a closed-ended questionnaire. Receives: Other: The oral health education intervention program |
| Control group: No Intervention | No intervention | They will have their regular curriculums and normal activity routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge on oral health status
The oral health knowledge assessment consists of eighteen multiple-choice questions scored as correct (1) or incorrect (0), categorized into four domains (dentition, dental caries, gingivitis, and oral cancer), and combined into a composite index with a total possible score ranging from 0 to 18.
Measured: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
Attitude on oral health status
A 12-item, five-point Likert scale questionnaire wiil be used to assess attitudes toward maintaining oral hygiene, with five negatively worded items inversely recoded, yielding total scores ranging from 12 to 60.
Measured: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
Practice on oral health status
There are 12 multiple-choice questions in this part. The correct answers will be coded as the highest score, and the wrong answers will be coded as '0'. There is a maximum score of 18 and a minimum of 0.
Measured: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
Secondary outcomes (2)
Self efficacy
A seven-item self-reported questionnaire will be used to assess students' self-efficacy towards oral health, with respondents rating their confidence on a 5-point Likert scale ranging from "Not confident" to "Completely confident."
Measured: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
Social support Appraisals
The Social Support Appraisals Scale is a 23-item questionnaire with five response options that measures the extent to which individuals feel loved, esteemed, and involved with family, friends, and others.
Measured: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Mar 2024
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 430 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Putra Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Khalid Salem Alsharif, Universiti Putra Malaysia
- Investigators
- Ahmad Iqmer Nashriq Mohd Nazan, PhD, Study director, Universiti Putra Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009015
- Sponsor's protocol ID
- MKSalemAlsharif
- Status last verified
- Jul 2025
- First submitted
- 21 May 2025
- Last updated
- 15 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Health Education Intervention Program In Improving Knowledge, Attitude, And Practice Of Oral Health Among Male Primary School Children In Al-Lith Saudi Arabia: A Clustered Randomised Control Trial
- ClinicalTrials.gov ID
- NCT07009015
- Acronym / sponsor ID
- MKSalemAlsharif
- Conditions
- Dental Caries in Children
- Keywords
- Dental caries, Oral health status, Knowledge, Attitude, Practice
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 430 participants (estimated)
- Lead sponsor
- Universiti Putra MalaysiaUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 6 Jun 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.
Dental caries remains a significant global public health issue, particularly affecting children's health, development, and well-being, with inadequate knowledge, attitudes, and practices around oral health exacerbating these impacts. To address this, a cluster randomized controlled trial will be conducted in four primary schools in Al Lith City, Saudi Arabia, targeting children aged 10 to 11 years. The intervention involves interactive, classroom-based educational sessions led by a dental care professional, supplemented by take-home materials, focusing first on enhancing knowledge and attitudes, and then on developing behavioral skills for improved oral hygiene and eating habits. Participants' knowledge, attitudes, and practices will be assessed via questionnaires before, immediately after, and six months post-intervention, with data analyzed using SPSS through descriptive statistics, chi-square tests, One Way-ANOVA, and Generalized Estimating Equations. The study expects that school-based oral health education will significantly improve children's oral health knowledge and certain hygiene behaviors, as well as positively influence eating habits and patterns.
Detailed description
Background: Dental caries is a global public health concern and impacts children's health. Good oral health status at a young age is essential for children's development, general health, and well-being. Therefore, a lack of knowledge, attitude, and practice on oral health will affect children's development, overall health, and well-being. This study aims to evaluate a brief oral health intervention in schools by a primary dental care practitioner in improving the knowledge, practice, and attitude toward oral health care among primary school children in Al Lith City, Saudi Arabia. A cluster randomized controlled trial (CRCT) will be conducted in four schools in Al Lith City, Saudi Arabia, among children aged 10 to 11 years old. Methods: 160 children will receive classroom-based interactive educational sessions delivered by a dental care professional and receive take-home literature on oral health. The first session will focus on developing the participant's knowledge and attitude toward oral health. In contrast, the second session will cover topics on behavioural skills improvement to apply the knowledge and skills gained from the first session to improve their targeted behaviours of oral hygiene and eating habits. All children will complete a questionnaire on oral health knowledge, attitude, and practice before, immediately after, and six months following the intervention. Data will be analyzed using SPSS. Data will be presented by descriptive statistics. Chi-square test will be used to determine the association between the variables of the study. One Way-ANOVA will determine the mean differences for the selected variables. A generalized Estimating Equations (GEE) will be used to test the effect of the oral health education program on the outcomes between and within the groups. Expected Results: School-based preventative oral health education delivered by primary dental care practices can improve children's knowledge of oral health and some aspects of oral hygiene behaviour. There are significant differences will be detected in eating habits and eating patterns.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| The oral health education intervention program | Other | Other: The oral health education intervention programThe intervention program aims to enhance students' oral health knowledge, attitudes, and behaviors over a one-month school term through educational and practical sessions, with its effectiveness assessed before and after the intervention using a closed-ended questionnaire. |
| Control group: No Intervention | No intervention | –They will have their regular curriculums and normal activity routine. |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Primary school male students.
- Aged 10 to 11 years old.
- Students who have at least one of their parent's consents to participate in the study.
Key exclusion criteria (2 listed)
- Students who are medically ill at the time of conducting the study.
- Students that are absent while conducting the study.
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 |
|---|---|---|
| The oral health education intervention programThe intervention program will be designed to improve oral health knowledge, attitudes, and behaviors among students over a one-month school term, carefully scheduled to avoid disrupting regular academic activities. The program consists of initial sessions focused on building students' understanding and appreciation of oral health and healthy eating habits, followed by sessions aimed at developing practical behavioral skills. The effectiveness of the program will be evaluated at three points-before the intervention, two months after, and four months post-intervention-using a closed-ended questionnaire to assess changes in knowledge, attitudes, and practices. | Other | The oral health education intervention program |
Primary outcome
Knowledge on oral health status
Time frame: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
The oral health knowledge assessment consists of eighteen multiple-choice questions scored as correct (1) or incorrect (0), categorized into four domains (dentition, dental caries, gingivitis, and oral cancer), and combined into a composite index with a total possible score ranging from 0 to 18.
Attitude on oral health status
Time frame: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
A 12-item, five-point Likert scale questionnaire wiil be used to assess attitudes toward maintaining oral hygiene, with five negatively worded items inversely recoded, yielding total scores ranging from 12 to 60.
Practice on oral health status
Time frame: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
There are 12 multiple-choice questions in this part. The correct answers will be coded as the highest score, and the wrong answers will be coded as '0'. There is a maximum score of 18 and a minimum of 0.
2 secondary outcomes
Self efficacy
Time frame: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
Social support Appraisals
Time frame: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2025.
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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.
Ahmad Iqmer Nashriq Mohd Nazan, PhD study director
Universiti Putra Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The oral health education intervention program in people with Dental Caries in Children, run by Universiti Putra Malaysia at 1 site in Malaysia.
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: looking for participants now, as of the sponsor's last update on 15 Jul 2025. 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 Malaysia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Alsharif, Master (+60145690140, mksharef@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge on oral health status (time frame: (Timepoint 1 = Baseline, Timepoint 2 = 8-weeks post intervention, Timepoint 3 = 16-weeks post intervention)). The study lists 3 primary outcomes in all. 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 15 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.