Dental CariesNCT03345680
Examining the Impact of School-based Dental Screening
A study testing Referred to a specific hospital for treatment in people with Dental Caries, run by King's College London at 1 site in United Kingdom.
Trial summary
This study examines the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Referred to a specific hospital for treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 996 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Oct 2017to 1 Jan 2020
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 11 years (1st -5th 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 6th grade (12-year-olds) as they would have left schools by the time of the follow-up assessment (12 months later).
- Children with any medically compromised condition such as congenital heart disease, haematological conditions, immune deficiency disease and end-stage renal disease.
- Children that refuse to participate (assent) in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
King's College London
London, Great Britin, SE5 9RS
About this study
Official title: Examining the Impact of School-based Dental Screening Program on Dental Visits and Dental Caries Among Primary School Children in Riyadh City, Saudi Arabia: A Randomized Controlled Trial
This study examines the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.
Read the detailed description
Background: Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. School-based dental screening could be a potential intervention that might impact uptake of service and subsequently dental caries.
Aim: To examine the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.
Methods: This is a cluster randomized controlled trial comparing referral of screened-positive children to a specific treatment facility (King Saud University Dental College Hospital) against the current practice (information letter advising parents to take their child to a dentist). A total of 1000 children in 12 schools will be recruited. Schools (clusters) will be randomly selected and allocated to either group using computer software. Clinical assessment for dental caries will be conducted at baseline and after 12 months by dentists using the World Health Organisation (WHO) criteria. Different clinical teams will be used for each trial group to ensure blinded outcome assessment. Data on socio-demographic, behavioural and dental visits will be collected at baseline and follow-up. Outcome measures will be the change in number of decayed teeth and the number of dental visits over 12 months.
Discussion: This project will use a robust design to provide high level of evidence on the clinical benefits of school dental screening. The findings will potentially inform policies related to the continuation/ implementation of school-based dental screening in Saudi Arabia.
- Conditions
- Dental Caries
- Being tested
- Referred to a specific hospital for treatment
- Keywords
- Dental visits, School-based program, Dental screening, Dental Caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Referred to a specific hospital for treatmentOther
Also called Interventional group
To King Saud University Dental College, treatment will be provided free of charge to the referred participants.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Children will be screened, both parents and children will be informed of any abnormalities in the mouth. |
| Interventional Group | Experimental | Interventional (Dental Screening) Children will be screened for dental caries and referred to a specific hospital for treatment, namely King Saud University Dental College, treatment will be provided free of charge to the referred participants. Receives: Other: Referred to a specific hospital for treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the number of decayed teeth (untreated caries)
the change in the number of decayed teeth (untreated caries) in both primary and permanent teeth 12 months after intervention.
Measured: 12 months
Secondary outcomes (1)
Changes in the proportion of children with untreated caries and whether the child visited the dentist
The change in the proportion of children with untreated caries in both deciduous and permanent teeth and whether the child visited the dentist
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start10 Oct 2017
- Primary completion30 Dec 2018
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 996 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University
- Responsible party
- Sponsor
- Investigators
- Haya M Alayadi, MSc, Principal investigator, King's College LondonWael Sabbah, PhD, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345680
- Sponsor's protocol ID
- HR-16/17-4683
- Status last verified
- Oct 2017
- First submitted
- 6 Nov 2017
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will not be shared except to central participant and principal investigator
Publications
Arora A, Kumbargere Nagraj S, Khattri S, Ismail NM, Eachempati P. School dental screening programmes for oral health. Cochrane Database Syst Rev. 2022 Jul 27;7(7):CD012595. doi: 10.1002/14651858.CD012595.pub4.
PubMed 35894680Alayadi H, Sabbah W, Bernabe E. Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial. Trials. 2018 Apr 13;19(1):224. doi: 10.1186/s13063-018-2619-2.
PubMed 29653545
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Impact of School-based Dental Screening Program on Dental Visits and Dental Caries Among Primary School Children in Riyadh City, Saudi Arabia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03345680
- Acronym / sponsor ID
- HR-16/17-4683
- Conditions
- Dental Caries
- Keywords
- Dental visits, School-based program, Dental screening, Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 996 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King Saud University
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 30 Dec 2018 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 17 Nov 2017 (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.
This study examines the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.
Detailed description
Background: Dental caries is one of the most common diseases affecting children in Saudi Arabia despite the availability of free dental services. School-based dental screening could be a potential intervention that might impact uptake of service and subsequently dental caries.
Aim: To examine the effectiveness of school dental screening in promoting dental attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.
Methods: This is a cluster randomized controlled trial comparing referral of screened-positive children to a specific treatment facility (King Saud University Dental College Hospital) against the current practice (information letter advising parents to take their child to a dentist). A total of 1000 children in 12 schools will be recruited. Schools (clusters) will be randomly selected and allocated to either group using computer software. Clinical assessment for dental caries will be conducted at baseline and after 12 months by dentists using the World Health Organisation (WHO) criteria. Different clinical teams will be used for each trial group to ensure blinded outcome assessment. Data on socio-demographic, behavioural and dental visits will be collected at baseline and follow-up. Outcome measures will be the change in number of decayed teeth and the number of dental visits over 12 months.
Discussion: This project will use a robust design to provide high level of evidence on the clinical benefits of school dental screening. The findings will potentially inform policies related to the continuation/ implementation of school-based dental screening in Saudi Arabia.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Children will be screened, both parents and children will be informed of any abnormalities in the mouth. |
| Interventional Group | Experimental | Other: Referred to a specific hospital for treatmentInterventional (Dental Screening) Children will be screened for dental caries and referred to a specific hospital for treatment, namely King Saud University Dental College, treatment will be provided free of charge to the referred participants. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 to 11 years (1st -5th 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 (3 listed)
- Children in 6th grade (12-year-olds) as they would have left schools by the time of the follow-up assessment (12 months later).
- Children with any medically compromised condition such as congenital heart disease, haematological conditions, immune deficiency disease and end-stage renal disease.
- Children that refuse to participate (assent) 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 |
|---|---|---|
| Referred to a specific hospital for treatmentAlso: Interventional groupTo King Saud University Dental College, treatment will be provided free of charge to the referred participants. | Other | Interventional Group |
Primary outcome
change in the number of decayed teeth (untreated caries)
Time frame: 12 months
the change in the number of decayed teeth (untreated caries) in both primary and permanent teeth 12 months after intervention.
1 secondary outcome
Changes in the proportion of children with untreated caries and whether the child visited the dentist
Time frame: 12 months
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 12 Feb 2021.
- Derived from this study: PubMed 35894680Arora A, Kumbargere Nagraj S, Khattri S, Ismail NM, Eachempati P. School dental screening programmes for oral health. Cochrane Database Syst Rev. 2022 Jul 27;7(7):CD012595. doi: 10.1002/14651858.CD012595.pub4.
- Derived from this study: PubMed 29653545Alayadi H, Sabbah W, Bernabe E. Effectiveness of school dental screening on dental visits and untreated caries among primary schoolchildren: study protocol for a cluster randomised controlled trial. Trials. 2018 Apr 13;19(1):224. doi: 10.1186/s13063-018-2619-2.
- Individual participant dataSharing planned: No. data will not be shared except to central participant and principal investigator
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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.
Haya M Alayadi, MSc principal investigator
King's College London
Wael Sabbah, PhD study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Referred to a specific hospital for treatment in people with Dental Caries, run by King's College London at 1 site in United Kingdom.
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 3 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 12 Feb 2021. 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 United Kingdom. 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?
change in the number of decayed teeth (untreated caries) (time frame: 12 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 NCT03345680, which also lists 2 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 12 Feb 2021.