Dental Caries in ChildrenPhase 4NCT04196829
Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride
A Phase 4 study testing silver diamine fluoride ⁄ potassium Iodide and Silver Diamine Fluoride in people with Dental Caries in Children, run by Cairo University at 1 site in Egypt.
Trial summary
the main objective of this study is to evaluate staining potential and Caries Arresting Effect of silver diamine fluoride⁄potassium Iodide and silver diamine fluoride in carious anterior primary teeth Read more about this study
- Who is it for?
- Ages 3 to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries in Children
- What is being tested?
- silver diamine fluoride ⁄ potassium Iodide and Silver Diamine Fluoride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2020to Oct 2021
- Phase
- Phase 4
- 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 carious primary anterior teeth.
- Children with no spontaneous pain
Who cannot join
- Tooth mobility
- Signs of pulpal or periapical infection
- Severe medical conditions that would not allow management in the clinic
- Sensitivity to silver or other heavy-metal ions
- Presence of any gingival or perioral ulceration or stomatitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride in Carious Primary Anterior Teeth
the main objective of this study is to evaluate staining potential and Caries Arresting Effect of silver diamine fluoride⁄potassium Iodide and silver diamine fluoride in carious anterior primary teeth
Read the detailed description
Despite increased attention on caries prevention, not all children receive preventive treatments and large numbers still experience tooth decay. Primary care providers have had little option other than invasive and costly specialist treatment in the hospital under general anesthesia. In this context, there is interest in simple treatments to halt progress of carious lesions after tooth decay onset. Among these simple treatments is silver diamine fluoride (SDF) treatment. The major drawback to SDF treatment has been its black staining, which has limited its use. To counter the staining, researchers have tested SDF treatment immediately followed with application of saturated solution of potassium iodide (KI).
- Conditions
- Dental Caries in Children
- Being tested
- silver diamine fluoride ⁄ potassium Iodide, Silver Diamine Fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
silver diamine fluoride ⁄ potassium IodideDrug
Also called SDF / KI
The affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption . Then after SDF application KI will be applied using a separate microbrush which will be saturated by the solution and will be used to paint solution over carious lesion , no rinse will be performed and special instructions will be given following application
Silver Diamine FluorideDrug
Also called SDF
The affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption .
| Study group | Role | What they receive |
|---|---|---|
| silver diamine fluoride ⁄ potassium Iodide | Experimental | 38% silver diamine fluoride and a saturated solution of potassium iodide Receives: Drug: silver diamine fluoride ⁄ potassium Iodide |
| silver diamine fluoride | Active comparator | 38% silver diamine fluoride Receives: Drug: Silver Diamine Fluoride |
What is being measured
The primary outcome is the main question the study is designed to answer.
staining potential
change in color of carious lesion using spectrophotometer with unit of measurement percent
Measured: base line and Immediately after material application
Secondary outcomes (1)
caries arresting effect
evaluating hardness of carious lesion by tactile examination using probe, binary (soft or hard)
Measured: 3 months, 6 moths, 9 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start2 Jan 2020
- Primary completion12 Aug 2021
- Study completionOct 2021 (estimated)
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.
- More trials run by Cairo UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mohsen Aly, Cairo University
- Investigators
- Mariam Aly, Phd, Principal investigator, Lecturer, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196829
- Sponsor's protocol ID
- SDF staining potential
- Status last verified
- Sep 2021
- First submitted
- 8 Dec 2019
- Last updated
- 10 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Staining Potential and Caries Arresting Effect of Silver Diamine Fluoride⁄Potassium Iodide and Silver Diamine Fluoride in Carious Primary Anterior Teeth
- ClinicalTrials.gov ID
- NCT04196829
- Acronym / sponsor ID
- SDF staining potential
- Conditions
- Dental Caries in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 12 Aug 2021 (actual)
- Study completion
- Oct 2021 (estimated)
- First posted
- 12 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.
the main objective of this study is to evaluate staining potential and Caries Arresting Effect of silver diamine fluoride⁄potassium Iodide and silver diamine fluoride in carious anterior primary teeth
Detailed description
Despite increased attention on caries prevention, not all children receive preventive treatments and large numbers still experience tooth decay. Primary care providers have had little option other than invasive and costly specialist treatment in the hospital under general anesthesia. In this context, there is interest in simple treatments to halt progress of carious lesions after tooth decay onset. Among these simple treatments is silver diamine fluoride (SDF) treatment. The major drawback to SDF treatment has been its black staining, which has limited its use. To counter the staining, researchers have tested SDF treatment immediately followed with application of saturated solution of potassium iodide (KI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| silver diamine fluoride ⁄ potassium Iodide | Experimental | Drug: silver diamine fluoride ⁄ potassium Iodide38% silver diamine fluoride and a saturated solution of potassium iodide |
| silver diamine fluoride | Active comparator | Drug: Silver Diamine Fluoride38% silver diamine fluoride |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children with carious primary anterior teeth.
- Children with no spontaneous pain
Key exclusion criteria (5 listed)
- Tooth mobility
- Signs of pulpal or periapical infection
- Severe medical conditions that would not allow management in the clinic
- Sensitivity to silver or other heavy-metal ions
- Presence of any gingival or perioral ulceration or stomatitis
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 ⁄ potassium IodideAlso: SDF / KIThe affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption . Then after SDF application KI will be applied using a separate microbrush which will be saturated by the solution and will be used to paint solution over carious lesion , no rinse will be performed and special instructions will be given following application | Drug | silver diamine fluoride ⁄ potassium Iodide |
| Silver Diamine FluorideAlso: SDFThe affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption . | Drug | silver diamine fluoride |
Primary outcome
staining potential
Time frame: base line and Immediately after material application
change in color of carious lesion using spectrophotometer with unit of measurement percent
1 secondary outcome
caries arresting effect
Time frame: 3 months, 6 moths, 9 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2021.
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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.
Mariam Aly, Phd principal investigator
Lecturer, Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing silver diamine fluoride ⁄ potassium Iodide and Silver Diamine Fluoride in people with Dental Caries in Children, run by Cairo University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 10 Sep 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 Egypt. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
staining potential (time frame: base line and Immediately after material application). 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 10 Sep 2021.