Early Childhood CariesNCT05748054
Early Childhood Caries in Jordanian Children
A study testing Silver Diamine Fluoride in people with Early Childhood Caries, run by King Abdullah University Hospital at 1 site in Jordan.
Trial summary
In this cross sectional epidemiological study, we aimed to report the prevalence of early childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk factors. Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- Silver Diamine Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2019to 1 Feb 2021
- 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 3 to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with early childhood caries involving anterior and/or posterior primary teeth
- Children with with cavitated lesions with active caries
- Children with no clinical signs of pulp involvement
Who cannot join
- Children with grossly broken down teeth
- Children with teeth with more than one third of the crown missing
- Children with pulpally involved teeth (with pulp exposure, presence of an abscess or a sinus) Children with obvious discoloration, and abnormal mobility
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Childhood Caries in Jordanian Children: Prevalence, Risk Factors and Prevention Using Silver Diamine Fluoride
In this cross sectional epidemiological study, we aimed to report the prevalence of early childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk factors. We also, aimed to determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC. Children (n=887) with mean age 4.64 ± 1.56 were examined. Among this sample there was a number of children (n=159) who were enrolled in a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only).
Read the detailed description
Background: Early childhood caries is a well-known international public health challenge amongst young children.
Aims: To report the prevalence of early childhood caries in children attending kindergartens in Jordan, and its associated risk factors. To determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC.
Methods: This is a cross sectional epidemiological study comprised of children (n=887) with mean age 4.64 ± 1.56 who attended kindergartens of different cities in Jordan, this sample received questionnaires to fill data related to their demographic, socioeconomic, oral hygiene, oral health, nursing and nutritional habits. These children were also examined to determine early childhood caries prevalence in Jordan. Among this sample there was a number of children (n=159) with the mean age 4.8 ± 0.85 who were planned to be involved in a sample of a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only). Application of SDF started after distribution and receiving back approval letters from children's parents accompanied with questionnaires for data related to the approval/disapproval of the application. The sample were followed up for 1 year.
- Conditions
- Early Childhood Caries
- Being tested
- Silver Diamine Fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine FluorideDrug
Also called SDF
A colourless solution known with its alkaline nature; it simply consists of a union of silver, fluoride and ammonia. It can be applied on caries cavities using a micro-brush.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | Children who receive a single application of 38% SDF Receives: Drug: Silver Diamine Fluoride |
| Control group | No intervention | Children do not receive any intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of early childhood caries
The percentage of children with early childhood caries
Measured: After 1 year
Caries Prevention
Prevention of new cavities
Measured: After 1 year of SDF application
Caries arrest
Arrest of existing cavities
Measured: After 1 year of SDF application
Secondary outcomes (2)
Risk factors for early childhood caries
Early childhood caries risk factors questionnaire
Measured: After 1 year
Parental acceptance of SDF
Reasons for acceptance or unacceptance of SDF application
Measured: Before application of SDF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Nov 2019
- Primary completion1 Oct 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Early Childhood CariesStudies 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
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Ola B. Al-Batayneh, Principal investigator, Jordan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748054
- Sponsor's protocol ID
- 47/2019
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2023
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.
PubMed 16040729Mei ML, Chu CH, Low KH, Che CM, Lo EC. Caries arresting effect of silver diamine fluoride on dentine carious lesion with S. mutans and L. acidophilus dual-species cariogenic biofilm. Med Oral Patol Oral Cir Bucal. 2013 Nov 1;18(6):e824-31. doi: 10.4317/medoral.18831.
PubMed 23722131Ramos-Gomez FJ, Shepard DS. Cost-effectiveness model for prevention of early childhood caries. J Calif Dent Assoc. 1999 Jul;27(7):539-44.
PubMed 10530112Zhi QH, Lo EC, Lin HC. Randomized clinical trial on effectiveness of silver diamine fluoride and glass ionomer in arresting dentine caries in preschool children. J Dent. 2012 Nov;40(11):962-7. doi: 10.1016/j.jdent.2012.08.002. Epub 2012 Aug 11.
PubMed 22892463Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
PubMed 26831727
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Childhood Caries in Jordanian Children: Prevalence, Risk Factors and Prevention Using Silver Diamine Fluoride
- ClinicalTrials.gov ID
- NCT05748054
- Acronym / sponsor ID
- 47/2019
- Conditions
- Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- King Abdullah University HospitalUniversity, hospital or other
- Collaborators
- Jordan University of Science and Technology
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 28 Feb 2023 (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.
In this cross sectional epidemiological study, we aimed to report the prevalence of early childhood caries (ECC) in children attending kindergartens in Jordan, and its associated risk factors. We also, aimed to determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC. Children (n=887) with mean age 4.64 ± 1.56 were examined. Among this sample there was a number of children (n=159) who were enrolled in a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only).
Detailed description
Background: Early childhood caries is a well-known international public health challenge amongst young children.
Aims: To report the prevalence of early childhood caries in children attending kindergartens in Jordan, and its associated risk factors. To determine the effectiveness of silver diamine fluoride as a caries control material and its acceptance among parents of children with ECC.
Methods: This is a cross sectional epidemiological study comprised of children (n=887) with mean age 4.64 ± 1.56 who attended kindergartens of different cities in Jordan, this sample received questionnaires to fill data related to their demographic, socioeconomic, oral hygiene, oral health, nursing and nutritional habits. These children were also examined to determine early childhood caries prevalence in Jordan. Among this sample there was a number of children (n=159) with the mean age 4.8 ± 0.85 who were planned to be involved in a sample of a randomized controlled trial to study silver diamine fluoride efficacy in caries control. The sample consisted of two groups; the study group (children who received single spot application of 38% SDF) and control group (children who were examined only). Application of SDF started after distribution and receiving back approval letters from children's parents accompanied with questionnaires for data related to the approval/disapproval of the application. The sample were followed up for 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Drug: Silver Diamine FluorideChildren who receive a single application of 38% SDF |
| Control group | No intervention | –Children do not receive any intervention |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with early childhood caries involving anterior and/or posterior primary teeth
- Children with with cavitated lesions with active caries
- Children with no clinical signs of pulp involvement
Key exclusion criteria (3 listed)
- Children with grossly broken down teeth
- Children with teeth with more than one third of the crown missing
- Children with pulpally involved teeth (with pulp exposure, presence of an abscess or a sinus) Children with obvious discoloration, and abnormal mobility
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 |
|---|---|---|
| Silver Diamine FluorideAlso: SDFA colourless solution known with its alkaline nature; it simply consists of a union of silver, fluoride and ammonia. It can be applied on caries cavities using a micro-brush. | Drug | Study group |
Primary outcome
Prevalence of early childhood caries
Time frame: After 1 year
The percentage of children with early childhood caries
Caries Prevention
Time frame: After 1 year of SDF application
Prevention of new cavities
Caries arrest
Time frame: After 1 year of SDF application
Arrest of existing cavities
2 secondary outcomes
Risk factors for early childhood caries
Time frame: After 1 year
Parental acceptance of SDF
Time frame: Before application of SDF
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 7 Mar 2023.
- Background: PubMed 16040729Llodra JC, Rodriguez A, Ferrer B, Menardia V, Ramos T, Morato M. Efficacy of silver diamine fluoride for caries reduction in primary teeth and first permanent molars of schoolchildren: 36-month clinical trial. J Dent Res. 2005 Aug;84(8):721-4. doi: 10.1177/154405910508400807.
- Background: PubMed 23722131Mei ML, Chu CH, Low KH, Che CM, Lo EC. Caries arresting effect of silver diamine fluoride on dentine carious lesion with S. mutans and L. acidophilus dual-species cariogenic biofilm. Med Oral Patol Oral Cir Bucal. 2013 Nov 1;18(6):e824-31. doi: 10.4317/medoral.18831.
- Background: PubMed 10530112Ramos-Gomez FJ, Shepard DS. Cost-effectiveness model for prevention of early childhood caries. J Calif Dent Assoc. 1999 Jul;27(7):539-44.
- Background: PubMed 22892463Zhi QH, Lo EC, Lin HC. Randomized clinical trial on effectiveness of silver diamine fluoride and glass ionomer in arresting dentine caries in preschool children. J Dent. 2012 Nov;40(11):962-7. doi: 10.1016/j.jdent.2012.08.002. Epub 2012 Aug 11.
- Background: PubMed 26831727Gao SS, Zhang S, Mei ML, Lo EC, Chu CH. Caries remineralisation and arresting effect in children by professionally applied fluoride treatment - a systematic review. BMC Oral Health. 2016 Feb 1;16:12. doi: 10.1186/s12903-016-0171-6.
- Individual participant dataSharing planned: No
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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.
Ola B. Al-Batayneh principal investigator
Jordan University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silver Diamine Fluoride in people with Early Childhood Caries, run by King Abdullah University Hospital at 1 site in Jordan.
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 7 Mar 2023. 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 Jordan. 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?
Prevalence of early childhood caries (time frame: After 1 year). 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?
On the ClinicalTrials.gov record for NCT05748054, which also lists 5 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 7 Mar 2023.