Dental Caries in ChildrenPhase 2/3NCT04213573
Efficacy of Silver Diamine Fluoride and Its Parental Perception
A Phase 2/3 study testing silver diamine fluoride and MI Varnish in people with Dental Caries in Children, run by University of Baghdad at 1 site in Iraq.
Trial summary
This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- silver diamine fluoride and MI Varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIraq
- Study dates
- 21 Jan 2020to 20 Dec 2020
- Phase
- Phase 2/3
- 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 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Normal healthy children without any systemic disease ASA 1 physical status.
- Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)
Who cannot join
- Children who suffer from major systemic diseases and require long term medications.
- Children refuse the study intervention.
- Children with silver or milk product sensitivity.
- Presence of any gingival or perioral ulceration or stomatitis.
- Tooth with abscess, fistula or severe pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate
This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.
Read the detailed description
The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.
Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.
- Conditions
- Dental Caries in Children
- Being tested
- silver diamine fluoride, MI Varnish
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
38% silver diamine fluoride liquid will be applied with a brush
MI VarnishDrug
topical fluoride varnish with calcium and phosphate
| Study group | Role | What they receive |
|---|---|---|
| Group 1: topical application of silver diamine fluoride | Experimental | 38% silver diamine fluoride liquid Receives: Drug: silver diamine fluoride |
| Group 2: topical application of MI varnish. | Active comparator | MI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate Receives: Drug: MI Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
caries arrestment
The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by WHO probe
Measured: 2 weeks
Secondary outcomes (1)
Parent perception
parental perception for silver diamine fluoride staining will be conducted by questionnaire given to the parents
Measured: 0 - 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2019
- Study start21 Jan 2020
- Primary completion20 Oct 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
Why it stopped: because of corona virus epidemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Caries in ChildrenStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Mohammed Khammas, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04213573
- Sponsor's protocol ID
- AMKhammas
- Status last verified
- Mar 2020
- First submitted
- 18 Dec 2019
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate
- ClinicalTrials.gov ID
- NCT04213573
- Acronym / sponsor ID
- AMKhammas
- Conditions
- Dental Caries in Children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: because of corona virus epidemic
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 21 Jan 2020 (actual)
- Primary completion
- 20 Oct 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 30 Dec 2019 (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 randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.
Detailed description
The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.
Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: topical application of silver diamine fluoride | Experimental | Drug: silver diamine fluoride38% silver diamine fluoride liquid |
| Group 2: topical application of MI varnish. | Active comparator | Drug: MI VarnishMI Varnish:5% sodium fluoride varnish which also contains RECALDENT™* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Normal healthy children without any systemic disease ASA 1 physical status.
- Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)
Key exclusion criteria (5 listed)
- Children who suffer from major systemic diseases and require long term medications.
- Children refuse the study intervention.
- Children with silver or milk product sensitivity.
- Presence of any gingival or perioral ulceration or stomatitis.
- Tooth with abscess, fistula or severe pain.
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: SDF38% silver diamine fluoride liquid will be applied with a brush | Drug | Group 1: topical application of silver diamine fluoride |
| MI Varnishtopical fluoride varnish with calcium and phosphate | Drug | Group 2: topical application of MI varnish. |
Primary outcome
caries arrestment
Time frame: 2 weeks
The measure will be done using international caries detection and assessment system II (ICDAS II) criteria for diagnosing active and arrested caries by WHO probe
1 secondary outcome
Parent perception
Time frame: 0 - 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: Undecided
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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.
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 Phase 2/3 study testing silver diamine fluoride and MI Varnish in people with Dental Caries in Children, run by University of Baghdad at 1 site in Iraq.
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 2 inclusion and 5 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: paused, as of the sponsor's last update on 26 Mar 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 Iraq. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
caries arrestment (time frame: 2 weeks). 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 26 Mar 2020.