Oral Hygiene OrientationNCT07055659
Enhancing Oral Hygiene in Children Through an Innovative Motivational Model
A study testing Oral hygiene assessment in people with Oral Hygiene Orientation, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
Background Children are susceptible to dental caries and periodontal disease, which are both preventable. Anxiety and fear of dental pain and dentists are common among children worldwide, so it is important to encourage new strategies to overcome this condition. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene Orientation
- What is being tested?
- Oral hygiene assessment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 30 Apr 2025to 30 Jun 2026
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- medically -free children
Who cannot join
- Any child with any physical or mental disability will be excluded. puberty is a reason for exclusion too
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Oral Hygiene in Children Through an Innovative Motivational Model: A Randomized Controlled Trial
Background
Children are susceptible to dental caries and periodontal disease, which are both preventable.
Read more
Anxiety and fear of dental pain and dentists are common among children worldwide, so it is important to encourage new strategies to overcome this condition.
Illustrations and visual aids may be helpful in passing along oral hygiene instructions to children.
Rationale As a visual model, watering the plant is linked to brushing time. The evident growth of the plant as monitored by the child, can be helpful to instill the importance of maintaining proper dental hygiene.
Study objectives To motivate children to maintain proper oral health care.
Methods Forty 8 to 12 years old children (20 boys and 20 girls) will be randomly selected. Clinical oral examination is conducted to evaluate the dental caries and oral status gingival status of all children. Parents were asked to answer a simple questionnaire to assess oral health behaviors of their kids.
Read the detailed description
Introduction Children are susceptible to dental caries and periodontal disease, which are both preventable. (1) Poorly understood dental hygiene behaviors are considered factors that contribute to the prevalence of dental caries and plaque accumulation among children. (2) Moreover, anxiety and fear of dental pain and dentists are common among children worldwide, so it is important to encourage new strategies to overcome this condition. (3) Children's intention to improve oral hygiene behavior can be improved by addressing psychological and behavioral obstacles when creating positive social motivation. (4) Illustrations and visual aids may be helpful in passing along oral hygiene instructions to children. (5) When motivational methods were applied during toothbrushing, e.g. an hourglass timer or a music video, a statistically significant decrease was observed in Plaque Index and Gingival Index values. (6) In light of oral health contributes significantly to the promotion of general health and the prevention of chronic diseases. (7) As a result, both oral disease prevention and oral health promotion should be incorporated into chronic disease prevention and health promotion programs. (8) As a visual model, watering the plant is linked to brushing time. The evident growth of the plant as monitored by the child, can be helpful to instill the importance of maintaining proper dental hygiene.
- Research objectives The study aims to motivate children to maintain proper oral health care. Materials and methods Prospective, randomized, clinical trial study. 4.2.Study setting: Dental clinics at, college of dentistry, Qassim University 4.3.Study duration: three years. The study is estimated to be three years. 4.4.Sample size: The sample size are forty children between 8-12 years old 4.5.Sampling technique (with inclusion and exclusion criteria): Forty children will be randomly selected from the dental clinics of Qassim University. 40 medically -free children (20 boys and 20 girls) of age 8-12 years old are involved in the study. Any child with any physical or mental disability will be excluded. Moreover, puberty is a reason for exclusion too. The collected sample will be equally divided, into four groups with equal gender distribution. For boys ( Group A AND Group B),For girls ( Group A AND Group B).
Study sample: Group A Experimental sample: Group B Each group (A+B) will be given a toothbrush and toothpaste, and the explain to them correct oral hygiene..
For group B we will given him also the plant as a motivation . 4.6.Data collection methods:
- Clinical examination: the following clinical parameters are recorded: DMF and df, Gingival index, and Plaque index, using periodontal probe, dental explorer. Data will be collected on the first and last visit ( in day zero and day 90)
- Questionnaire: to assess oral health behaviors of the kids will be in the last visit (in day 90) for the parent 4.8.Data management and analysis plan: The collected data will be kept at the College of Dentistry - Qassim University No data access will be granted to unauthorized individuals. The data will be analyzed statistically. The descriptive data related to caries and plaque accumulation will be descriptively analyzed. The parent was asked to answer questionnaire for assessed on their oral health behaviors. The children age and gender will be calculated. Caries, gingival and plaque indices are used to assess plaque accumulation and evaluate the condition of the teeth and the gingiva. The questionnaire collected data would assess the of the child's interest in home care. The collected parameters will be collected and recorded in an Excel sheet and statistically analyzed. Data will be collected at baseline and after three months and will be analyzed using Statistical Package for Social Sciences (SPSS) version 21.0 .
4.9.Ethical considerations: The nature of the study will be explained to the mother of the child and informed consent will be obtained. No access will be granted to the code key to any unauthorized individuals.
- Conditions
- Oral Hygiene Orientation
- Being tested
- Oral hygiene assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene assessmentDiagnostic test
Also called DMF, Plaque Index, Gingival Index
experimental group will be given a plant to water it during 2-minute brushing habit. number of decayed teeth and and status of gingiva with the amount of plaque will be compared between the groups
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | group with plant: this is the experimental group: the child will be given a plant to water it during 2-minute brushing habit. DMF, Plaque index and gingival index (describing number of decayed teeth and and status of gingiva with the amount of plaque) all will be compared between the groups at the beginning and at the end of the study. Receives: Diagnostic Test: Oral hygiene assessment |
| Group B | Placebo comparator | group without plant: the control or placebo group: the child will not receive a plant but is instructed to brush his teeth for 2-minutes and keep this brushing habit for the whole period of the study.
DMF, Plaque index and gingival index (describing number of decayed teeth and and status of gingiva with the amount of plaque) all will be compared between the groups at the beginning and at the end of the study. Receives: Diagnostic Test: Oral hygiene assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical examination: Oral hygiene status
the following clinical parameters are recorded: DMF and df, Gingival index, and Plaque index, using periodontal probe, dental explorer. Data will be collected on the first and last visit ( in day zero and day 90).
DMF and df are expressed in number of decayed, missed or filled teeth at the beginning and at the end of the study. any increase would express worse situation.
Gingival index expresses inflammation in gingiva, that happens when gingiva is diseased (due to poor oral hygiene). the scores are 0-3, the higher the worse the situation.
Plaque index represents the amount of accumulated plaque, scored 0-3, the higher the worse the situation.
all records are taken at the beginning and at the end of the study, to compare the effect of giving a plant to the explementary group would or wouldn't improve oral hygiene of the child (less plaque) and preserve gingival health (less gingival index) and teeth (less DMF changes).
Measured: 90 days
Secondary outcomes (1)
Questionnaire
to assess oral health behaviors of the kids will be in the last visit (in day 90) for the parent.
The following questions are to be answered by parents:
Did your child show interest when watering his plant? Does your child brush himself twice a day? Does your child continue to water his plant twice a day? Did the growth of the plant motivate your child to continue brushing his teeth Do you think that your child's care for plants has encouraged him and increased his interest in oral health?
the answers are only yes or no to describe child's commitment to oral hygiene
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start30 Apr 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Hygiene OrientationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wesam Fathi, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055659
- Sponsor's protocol ID
- Qassim University "21-16-15"
- Status last verified
- Jun 2025
- First submitted
- 21 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: gender and age
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Oral Hygiene in Children Through an Innovative Motivational Model: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07055659
- Acronym / sponsor ID
- Qassim University "21-16-15"
- Conditions
- Oral Hygiene Orientation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Jul 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.
Background
Children are susceptible to dental caries and periodontal disease, which are both preventable.
Anxiety and fear of dental pain and dentists are common among children worldwide, so it is important to encourage new strategies to overcome this condition.
Illustrations and visual aids may be helpful in passing along oral hygiene instructions to children.
Rationale As a visual model, watering the plant is linked to brushing time. The evident growth of the plant as monitored by the child, can be helpful to instill the importance of maintaining proper dental hygiene.
Study objectives To motivate children to maintain proper oral health care.
Methods Forty 8 to 12 years old children (20 boys and 20 girls) will be randomly selected. Clinical oral examination is conducted to evaluate the dental caries and oral status gingival status of all children. Parents were asked to answer a simple questionnaire to assess oral health behaviors of their kids.
Detailed description
Introduction Children are susceptible to dental caries and periodontal disease, which are both preventable. (1) Poorly understood dental hygiene behaviors are considered factors that contribute to the prevalence of dental caries and plaque accumulation among children. (2) Moreover, anxiety and fear of dental pain and dentists are common among children worldwide, so it is important to encourage new strategies to overcome this condition. (3) Children's intention to improve oral hygiene behavior can be improved by addressing psychological and behavioral obstacles when creating positive social motivation. (4) Illustrations and visual aids may be helpful in passing along oral hygiene instructions to children. (5) When motivational methods were applied during toothbrushing, e.g. an hourglass timer or a music video, a statistically significant decrease was observed in Plaque Index and Gingival Index values. (6) In light of oral health contributes significantly to the promotion of general health and the prevention of chronic diseases. (7) As a result, both oral disease prevention and oral health promotion should be incorporated into chronic disease prevention and health promotion programs. (8) As a visual model, watering the plant is linked to brushing time. The evident growth of the plant as monitored by the child, can be helpful to instill the importance of maintaining proper dental hygiene.
- Research objectives The study aims to motivate children to maintain proper oral health care. Materials and methods Prospective, randomized, clinical trial study. 4.2.Study setting: Dental clinics at, college of dentistry, Qassim University 4.3.Study duration: three years. The study is estimated to be three years. 4.4.Sample size: The sample size are forty children between 8-12 years old 4.5.Sampling technique (with inclusion and exclusion criteria): Forty children will be randomly selected from the dental clinics of Qassim University. 40 medically -free children (20 boys and 20 girls) of age 8-12 years old are involved in the study. Any child with any physical or mental disability will be excluded. Moreover, puberty is a reason for exclusion too. The collected sample will be equally divided, into four groups with equal gender distribution. For boys ( Group A AND Group B),For girls ( Group A AND Group B).
Study sample: Group A Experimental sample: Group B Each group (A+B) will be given a toothbrush and toothpaste, and the explain to them correct oral hygiene..
For group B we will given him also the plant as a motivation . 4.6.Data collection methods:
- Clinical examination: the following clinical parameters are recorded: DMF and df, Gingival index, and Plaque index, using periodontal probe, dental explorer. Data will be collected on the first and last visit ( in day zero and day 90)
- Questionnaire: to assess oral health behaviors of the kids will be in the last visit (in day 90) for the parent 4.8.Data management and analysis plan: The collected data will be kept at the College of Dentistry - Qassim University No data access will be granted to unauthorized individuals. The data will be analyzed statistically. The descriptive data related to caries and plaque accumulation will be descriptively analyzed. The parent was asked to answer questionnaire for assessed on their oral health behaviors. The children age and gender will be calculated. Caries, gingival and plaque indices are used to assess plaque accumulation and evaluate the condition of the teeth and the gingiva. The questionnaire collected data would assess the of the child's interest in home care. The collected parameters will be collected and recorded in an Excel sheet and statistically analyzed. Data will be collected at baseline and after three months and will be analyzed using Statistical Package for Social Sciences (SPSS) version 21.0 .
4.9.Ethical considerations: The nature of the study will be explained to the mother of the child and informed consent will be obtained. No access will be granted to the code key to any unauthorized individuals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Diagnostic Test: Oral hygiene assessmentgroup with plant: this is the experimental group: the child will be given a plant to water it during 2-minute brushing habit. DMF, Plaque index and gingival index (describing number of decayed teeth and and status of gingiva with the amount of plaque) all will be compared between the groups at the beginning and at the end of the study. |
| Group B | Placebo comparator | Diagnostic Test: Oral hygiene assessmentgroup without plant: the control or placebo group: the child will not receive a plant but is instructed to brush his teeth for 2-minutes and keep this brushing habit for the whole period of the study. DMF, Plaque index and gingival index (describing number of decayed teeth and and status of gingiva with the amount of plaque) all will be compared between the groups at the beginning and at the end of the study. |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- medically -free children
Key exclusion criteria (1 listed)
- Any child with any physical or mental disability will be excluded. puberty is a reason for exclusion too
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 |
|---|---|---|
| Oral hygiene assessmentAlso: DMF, Plaque Index, Gingival Indexexperimental group will be given a plant to water it during 2-minute brushing habit. number of decayed teeth and and status of gingiva with the amount of plaque will be compared between the groups | Diagnostic test | Group A, Group B |
Primary outcome
Clinical examination: Oral hygiene status
Time frame: 90 days
the following clinical parameters are recorded: DMF and df, Gingival index, and Plaque index, using periodontal probe, dental explorer. Data will be collected on the first and last visit ( in day zero and day 90). DMF and df are expressed in number of decayed, missed or filled teeth at the beginning and at the end of the study. any increase would express worse situation. Gingival index expresses inflammation in gingiva, that happens when gingiva is diseased (due to poor oral hygiene). the scores are 0-3, the higher the worse the situation. Plaque index represents the amount of accumulated plaque, scored 0-3, the higher the worse the situation. all records are taken at the beginning and at the end of the study, to compare the effect of giving a plant to the explementary group would or wouldn't improve oral hygiene of the child (less plaque) and preserve gingival health (less gingival index) and teeth (less DMF changes).
1 secondary outcome
Questionnaire
Time frame: 90 days
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 9 Jul 2025.
- Individual participant dataSharing planned: Yes. gender and age
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 Oral hygiene assessment in people with Oral Hygiene Orientation, run by Qassim University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 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 Saudi Arabia. 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. Some participants in this study may receive a placebo. 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?
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?
Clinical examination: Oral hygiene status (time frame: 90 days). 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 9 Jul 2025.