Caries ArrestedNCT04642846
Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction
A study testing Silver Diamine Fluoride (SDF) in people with Caries Arrested, run by Khalood Saeed Bahammam at 1 site in Saudi Arabia.
Trial summary
Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Arrested
- What is being tested?
- Silver Diamine Fluoride (SDF)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 21 Nov 2020to 1 Sep 2022
- 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between four and six years of age.
- Healthy.
- Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or 6.
- Should not have periapical infection, root resorption or widening in the periodontal ligament space.
Who cannot join
- Participants who have systemic or neurological diseases.
- Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility,
- Allergic to silver or any dental material to be used.
- Unable to attend follow-up visits.
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Imam Abdulrahman Bin Faisal University
Dammam, Eastern Province
Khalood S Bahammam, 0546128448, khulod.s.b@gmail.com
Yasmeen Y Muazen, 0594733611, yas.muazen@hotmail.com
About this study
Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Also, it was found that 78% of 6-9 years old children in Dammam had caries with an average of 3.66±3.13 DMFT.
The objectives of this study are:
Read more
- To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
- To assess the antibacterial effect of the Silver Diamine Fluoride (SDF).
- To assess parents' and children's satisfaction and acceptance.
The aims of our study are to assess the effectiveness of SDF in arresting caries in primary dentition among children visiting Imam Abdulrahman bin Faisal University in Dammam, Saudi Arabia and to assess parental acceptance and satisfaction.
The expected outcome the results of this study will help in understanding the effectiveness SDF in arresting dental caries in this target population especially that it was recently approved for clinical use in Saudi Arabia.
- Conditions
- Caries Arrested
- Being tested
- Silver Diamine Fluoride (SDF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silver Diamine Fluoride (SDF)Other
Silver diamine fluoride (SDF) is one of the topical methods for caries arresting. The advantages of using SDF include ease of use, low cost, pain and infection control, minimal requirement of time/training and non-invasive nature of the procedure. SDF can improve oral health, increase access to care and reduce the need for emergency treatment
| Study group | Role | What they receive |
|---|---|---|
| one application of SDF | Experimental | Not described Receives: Other: Silver Diamine Fluoride (SDF) |
| two application of SDF one month apart | Experimental | Not described Receives: Other: Silver Diamine Fluoride (SDF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
Caries arresting rate: total number of arrested teeth/ total number of treated teeth.
Measured: 2 years
Secondary outcomes (3)
Clinical changes of dentinal lesion: in the hardness and softness.
Changes in ICDAS score: post treatment change in carious lesion status.
Measured: 2 years
The antibacterial effect of the Silver Diamine Fluoride (SDF).
by DNA extractions and performed the 16S rRNA sequencing
Measured: 2 years
Parents satisfaction
To assess parents' and children's satisfaction and acceptance by questionnaire (Arabic and English). Link: https://forms.office.com/Pages/ResponsePage.aspx?id=_LuGLASN_0GoOpQvB14PYCVJ8_tHLjNCkOqqrov3N-1UMFlYRzFQUVRKMDhNUEtJR1ZXNkk4SzhGWS4u
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start21 Nov 2020 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries ArrestedStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khalood Saeed Bahammam
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Khalood Saeed Bahammam, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642846
- Sponsor's protocol ID
- IAU
- Status last verified
- Nov 2020
- First submitted
- 7 Oct 2020
- Last updated
- 24 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Laboratory Assessments of Effectiveness of Silver Diamine Fluoride (SDF) in Arresting Caries Among Children and Parental Satisfaction
- ClinicalTrials.gov ID
- NCT04642846
- Acronym / sponsor ID
- IAU
- Conditions
- Caries Arrested
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Khalood Saeed BahammamUniversity, hospital or other
- Study start
- 21 Nov 2020 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 24 Nov 2020 (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.
Globally, it is estimated that 2.4 billion people suffer from caries of permanent teeth and 486 million children suffer from caries of primary teeth . The highest estimate of dental caries prevalence in Saudi Arabia was 95% with maximum DMFT of 7.34 among 3-7 years old children . Also, it was found that 78% of 6-9 years old children in Dammam had caries with an average of 3.66±3.13 DMFT.
The objectives of this study are:
- To assess the effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
- To assess the antibacterial effect of the Silver Diamine Fluoride (SDF).
- To assess parents' and children's satisfaction and acceptance.
The aims of our study are to assess the effectiveness of SDF in arresting caries in primary dentition among children visiting Imam Abdulrahman bin Faisal University in Dammam, Saudi Arabia and to assess parental acceptance and satisfaction.
The expected outcome the results of this study will help in understanding the effectiveness SDF in arresting dental caries in this target population especially that it was recently approved for clinical use in Saudi Arabia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| one application of SDF | Experimental | Other: Silver Diamine Fluoride (SDF) |
| two application of SDF one month apart | Experimental | Other: Silver Diamine Fluoride (SDF) |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children between four and six years of age.
- Healthy.
- Have at least two active dentin carious lesions on the primary teeth meeting the International Caries Detection and Assessment System (ICDAS) score 5 or 6.
- Should not have periapical infection, root resorption or widening in the periodontal ligament space.
Key exclusion criteria (4 listed)
- Participants who have systemic or neurological diseases.
- Tooth abscess, pain on percussion, symptoms of pulpal involvement or mobility,
- Allergic to silver or any dental material to be used.
- Unable to attend follow-up visits.
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 Fluoride (SDF)Silver diamine fluoride (SDF) is one of the topical methods for caries arresting. The advantages of using SDF include ease of use, low cost, pain and infection control, minimal requirement of time/training and non-invasive nature of the procedure. SDF can improve oral health, increase access to care and reduce the need for emergency treatment | Other | one application of SDF, two application of SDF one month apart |
Primary outcome
Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries.
Time frame: 2 years
Caries arresting rate: total number of arrested teeth/ total number of treated teeth.
3 secondary outcomes
Clinical changes of dentinal lesion: in the hardness and softness.
Time frame: 2 years
The antibacterial effect of the Silver Diamine Fluoride (SDF).
Time frame: 2 years
Parents satisfaction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Caries Arrested
Not yet recruitingPhase 3
Effectiveness of Single and Dual Silver Fluoride Application
Dentine Caries
Active, not recruiting
Comparing Two Brands of Silver Diamine Fluoride for Stopping Cavities in Children
Dental Caries
Recruiting
Comparison of MI Paste Plus and Resin Infiltration in White Spot Lesions Following Orthodontic Treatment
White Spot Lesions, Orthodontic Appliance Complication
Active, not recruitingPhase 2
Arresting Early Childhood Caries With a Silver Diamine Fluoride Gel
Early Childhood Caries
Not yet recruiting
Efficacy of Silver Diamine Fluoride Versus Nano-Silver Fluoride in Arresting Active Dentin Caries in Primary Teeth in Young Children
Early Childhood Caries (ECC), Active Dentin Caries in Primary Molars
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.
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 (SDF) in people with Caries Arrested, run by Khalood Saeed Bahammam 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 4 inclusion and 4 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 24 Nov 2020. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the Silver Diamine Fluoride (SDF) in arresting caries. (time frame: 2 years). 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 24 Nov 2020.