Dental Caries in ChildrenNCT05217316
Impact of Virtual Supervised Tooth Brushing Among Primary School Children in Riyadh, KSA
A study testing Supervised Virtual Toothbrushing in people with Dental Caries in Children, run by King's College London at 1 site in Saudi Arabia.
Trial summary
Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. The combination of the large burden of untreated caries among school children, low uptake of dental services when asymptomatic and the availability of free dental services makes Saudi… Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- Supervised Virtual Toothbrushing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Dec 2021to Jun 2023
- 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 8 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 8 to 9 years (4th grade at school) at baseline
- Both Saudis and non-Saudis
- Children for whom the person with parental responsibility has signed the consent form
Who cannot join
- Children in 5th and 6th grade (11- 12-year-olds) as they would have left schools by the time of the follow-up assessment (18 months later).
- Children who refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
Areej Alsiwat contact
Saudi Arabia1 site, 1 recruiting
- Recruiting
Haya Alayadi
Riyāḑ, Riyadh Region, 12371
Haya Alayadi, PhD, +966551679833, halayadi@ksu.edu.sa
Areej Alsiwat, +966503447012, aalsiwat@ksu.edu.sa
About this study
Official title: Assess the Impact of Virtual Supervised Tooth Brushing on Dental Caries and Quality of Life Among Primary School Children in Riyadh, KSA
Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. The combination of the large burden of untreated caries among school children, low uptake of dental services when asymptomatic and the availability of free dental services makes Saudi Arabia a unique setting for school-based dental programs. Despite the availability of free dental services provided through the Ministry of Health, universities' hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when in pain.
As schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.
Read the detailed description
Background Dental caries is one of the most common diseases that afflict children in the Kingdom of Saudi Arabia and despite the availability of free dental services provided through the Ministry of Health, universities, hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when they are in pain thus, they reach the health care when they need complex care.
Aim The aim is to assess the impact of virtual supervised toothbrushing on dental caries and quality of life among primary school children in Riyadh, KSA.
Research Methodology This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). A 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months) by dental hygienist using World Health Organization criteria. Data on socio-demographic behavioral factors and children's quality of life will be collected at baseline and 12 months later through a structured questionnaire. The primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months. The secondary outcomes are the change in the frequency of brushing per day and the impact of oral health on the child's daily life (QoL).
Research Significance Schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.
- Conditions
- Dental Caries in Children
- Being tested
- Supervised Virtual Toothbrushing
- Keywords
- Toothbrushing, Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Virtual ToothbrushingBehavioural
A supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child. All virtual appointments will be conducted using the collaboration of two national platforms. "Mawid", a Ministry of health (MOH) Central Appointment System, to be used by the subjects. And "ANAT" system, a Saudi Commission for Health Specialists (SCHS) application for the hygienists to use for their virtual supervision.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Control group will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. |
| Intervention Group | Experimental | Both groups will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child. Receives: Behavioral: Supervised Virtual Toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Caries
The study primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months.
Measured: 18 months
Secondary outcomes (2)
Frequency of Brushing
The change in the frequency of brushing per day
Measured: 1 year
Quality of Child's Daily Life
The impact of oral health on the child's daily life (QoL).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Dec 2021
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental Caries in ChildrenStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering. Schools will be randomly selected and allocated in two groups, intervention, and control group (10 schools for each group). Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months). Both groups will receive oral assessment and both will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for each child.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Responsible party
- Sponsor
- Investigators
- Haya Alayadi, PhD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217316
- Sponsor's protocol ID
- E-21-5925
- Status last verified
- Jan 2022
- First submitted
- 14 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This will be applied by pseudo-anonymization. A separate file all personal identifiable information for all subjects will be kept in a separate file by the principal investigator. In addition, an artificial identifier (code) will be assigned to each subject as he enrolled in the study. All the study team members will deal with coded data while collecting or analyzing information. Only the codes will be used in data entry without any identifiable personal information.
Publications
Almas K, Al-Malik TM, Al-Shehri MA, Skaug N. The knowledge and practices of oral hygiene methods and attendance pattern among school teachers in Riyadh, Saudi Arabia. Saudi Med J. 2003 Oct;24(10):1087-91.
PubMed 14578974El Bcheraoui C, Tuffaha M, Daoud F, Kravitz H, AlMazroa MA, Al Saeedi M, Memish ZA, Basulaiman M, Al Rabeeah AA, Mokdad AH. Use of dental clinics and oral hygiene practices in the Kingdom of Saudi Arabia, 2013. Int Dent J. 2016 Apr;66(2):99-104. doi: 10.1111/idj.12210. Epub 2016 Jan 7.
PubMed 26749526Al-Yousuf M, Akerele TM, Al-Mazrou YY. Organization of the Saudi health system. East Mediterr Health J. 2002 Jul-Sep;8(4-5):645-53.
PubMed 15603048Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
PubMed 25740856Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
PubMed 28792274Holland WW, Stewart S. Screening in health care. Benefit or bane? London: The Nuffield Provincial Hospitals Trust; 1990.
World Health Organization. Oral health surveys: basic methods. 5th ed. Geneva: World Health Organization; 2013.
Alayadi H, Alsiwat A, AlAkeel H, Alaskar M, Alwadi M, Sabbah W. Impact of virtual supervised tooth brushing on caries experience and quality of life among primary school children: study protocol for a randomized controlled trial. Trials. 2023 Feb 20;24(1):118. doi: 10.1186/s13063-023-07111-8.
PubMed 36803406
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Impact of Virtual Supervised Tooth Brushing on Dental Caries and Quality of Life Among Primary School Children in Riyadh, KSA
- ClinicalTrials.gov ID
- NCT05217316
- Acronym / sponsor ID
- E-21-5925
- Conditions
- Dental Caries in Children
- Keywords
- Toothbrushing, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Ministry of Health, Saudi Arabia
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Feb 2022 (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 is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. The combination of the large burden of untreated caries among school children, low uptake of dental services when asymptomatic and the availability of free dental services makes Saudi Arabia a unique setting for school-based dental programs. Despite the availability of free dental services provided through the Ministry of Health, universities' hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when in pain.
As schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.
Detailed description
Background Dental caries is one of the most common diseases that afflict children in the Kingdom of Saudi Arabia and despite the availability of free dental services provided through the Ministry of Health, universities, hospitals and health services of the Ministry of Defense, most Saudis visit the dentist only when they are in pain thus, they reach the health care when they need complex care.
Aim The aim is to assess the impact of virtual supervised toothbrushing on dental caries and quality of life among primary school children in Riyadh, KSA.
Research Methodology This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). A 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering will be randomly selected and allocated to groups. Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months) by dental hygienist using World Health Organization criteria. Data on socio-demographic behavioral factors and children's quality of life will be collected at baseline and 12 months later through a structured questionnaire. The primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months. The secondary outcomes are the change in the frequency of brushing per day and the impact of oral health on the child's daily life (QoL).
Research Significance Schools are carried out virtually and Saudi Arabia has proved effective IT infrastructure, virtual supervised tooth brushing is a proposed initiative. It is also an opportunity for targeting a large portion of the population with a high level of disease as a quarter of the Saudi population is younger than 15 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- This is a cluster randomized controlled trial comparing virtual supervised tooth brushing program against conventional oral hygiene program (lecture and tooth brushing demonstration). 1280 children in 20 primary schools in Riyadh, Saudi Arabia will be recruited to the trail. Schools are the unit of clustering. Schools will be randomly selected and allocated in two groups, intervention, and control group (10 schools for each group). Clinical assessment for dental caries will be conducted in four points (baseline, 6 months, 12 months, 18 months). Both groups will receive oral assessment and both will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for each child.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Control group will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. |
| Intervention Group | Experimental | Behavioral: Supervised Virtual ToothbrushingBoth groups will receive a videos five times a week that illustrate a unified toothbrushing technique and remind the child to brush their teeth. The intervention lies in which the intervention group will receive a supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 8 to 9 years (4th grade at school) at baseline
- Both Saudis and non-Saudis
- Children for whom the person with parental responsibility has signed the consent form
Key exclusion criteria (2 listed)
- Children in 5th and 6th grade (11- 12-year-olds) as they would have left schools by the time of the follow-up assessment (18 months later).
- Children who refuse to participate in 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 |
|---|---|---|
| Supervised Virtual ToothbrushingA supervised virtual toothbrushing performed once a week for all students by dental hygienist that will be performed through a prescheduled virtual appointment for each child. All virtual appointments will be conducted using the collaboration of two national platforms. "Mawid", a Ministry of health (MOH) Central Appointment System, to be used by the subjects. And "ANAT" system, a Saudi Commission for Health Specialists (SCHS) application for the hygienists to use for their virtual supervision. | Behavioural | Intervention Group |
Primary outcome
Dental Caries
Time frame: 18 months
The study primary outcome is the change in the number of teeth with untreated dental caries in both primary and permanent teeth over 18 months.
2 secondary outcomes
Frequency of Brushing
Time frame: 1 year
Quality of Child's Daily Life
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Background: PubMed 14578974Almas K, Al-Malik TM, Al-Shehri MA, Skaug N. The knowledge and practices of oral hygiene methods and attendance pattern among school teachers in Riyadh, Saudi Arabia. Saudi Med J. 2003 Oct;24(10):1087-91.
- Background: PubMed 26749526El Bcheraoui C, Tuffaha M, Daoud F, Kravitz H, AlMazroa MA, Al Saeedi M, Memish ZA, Basulaiman M, Al Rabeeah AA, Mokdad AH. Use of dental clinics and oral hygiene practices in the Kingdom of Saudi Arabia, 2013. Int Dent J. 2016 Apr;66(2):99-104. doi: 10.1111/idj.12210. Epub 2016 Jan 7.
- Background: PubMed 15603048Al-Yousuf M, Akerele TM, Al-Mazrou YY. Organization of the Saudi health system. East Mediterr Health J. 2002 Jul-Sep;8(4-5):645-53.
- Background: PubMed 25740856Kassebaum NJ, Bernabe E, Dahiya M, Bhandari B, Murray CJ, Marcenes W. Global burden of untreated caries: a systematic review and metaregression. J Dent Res. 2015 May;94(5):650-8. doi: 10.1177/0022034515573272. Epub 2015 Mar 4.
- Background: PubMed 28792274Kassebaum NJ, Smith AGC, Bernabe E, Fleming TD, Reynolds AE, Vos T, Murray CJL, Marcenes W; GBD 2015 Oral Health Collaborators. Global, Regional, and National Prevalence, Incidence, and Disability-Adjusted Life Years for Oral Conditions for 195 Countries, 1990-2015: A Systematic Analysis for the Global Burden of Diseases, Injuries, and Risk Factors. J Dent Res. 2017 Apr;96(4):380-387. doi: 10.1177/0022034517693566.
- BackgroundHolland WW, Stewart S. Screening in health care. Benefit or bane? London: The Nuffield Provincial Hospitals Trust; 1990.
- BackgroundWorld Health Organization. Oral health surveys: basic methods. 5th ed. Geneva: World Health Organization; 2013.
- Derived from this study: PubMed 36803406Alayadi H, Alsiwat A, AlAkeel H, Alaskar M, Alwadi M, Sabbah W. Impact of virtual supervised tooth brushing on caries experience and quality of life among primary school children: study protocol for a randomized controlled trial. Trials. 2023 Feb 20;24(1):118. doi: 10.1186/s13063-023-07111-8.
- Individual participant dataSharing planned: Yes. This will be applied by pseudo-anonymization. A separate file all personal identifiable information for all subjects will be kept in a separate file by the principal investigator. In addition, an artificial identifier (code) will be assigned to each subject as he enrolled in the study. All the study team members will deal with coded data while collecting or analyzing information. Only the codes will be used in data entry without any identifiable personal information.
Related trials for Dental Caries in Children
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruiting
This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
Dental Caries, Early Childhood Caries (ECC)
Recruiting
A Study to Evaluate the Cariostatic Efficacy of Nano Silver Fluoride (NSF) vs. Silver Diamine Fluoride (SDF) in Children
Dental Caries
Not yet recruiting
Effect of Bioactive Glass Varnish on Salivary Parameters in Children: Randomized Controlled Trial
Prevention of Dental Caries
Active, not recruiting
Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children
Dental Caries, Tooth Injuries
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.
Areej Alsiwat contact
Haya Alayadi, PhD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Virtual Toothbrushing in people with Dental Caries in Children, run by King's College London 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 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: status not confirmed, as of the sponsor's last update on 1 Feb 2022. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Haya Alayadi (+966551679833, halayadi@ksu.edu.sa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental Caries (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217316, which also lists 8 linked publications.
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 1 Feb 2022.