Early Childhood CariesNCT04514094
Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC
A study testing SDF and ART in people with Early Childhood Caries, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Early Childhood Caries
- What is being tested?
- SDF and ART
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 23 Aug 2019
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- For children:
- Healthy children.
- Age range 2-5 years.
- Informed consent (Appendix I)
- For teeth:
- Teeth with active dentin lesions corresponding to ICDAS II score 5 and 6.
- Teeth having lesions that are considered active according to ICDAS II activity criteria for coronal primary caries.
Who cannot join
- For children:
- Children with systemic diseases.
- Children with reported allergy to silver or to any other component in the materials used.
- Children unable to return for recall visits.
- For teeth:
- Clinical or radiographic signs of pulpal involvement.(pain, abscess, sinus, obvious discoloration, premature hypermobility, internal or external root resorption).
- Teeth with inactive lesions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Silver Diamine Fluoride in Arresting Early Childhood Caries: Randomized Controlled Clinical Trial
The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
Read the detailed description
Owing to the virulent nature of early childhood caries (ECC) and its consequences if left untreated, immediate intervention is indicated to control the condition.
Barriers to intervention as young age, uncooperative patient behavior and lack of access to dental care are however, very common. The use of silver diamine fluoride as an anticaries agent is of growing popularity worldwide due to its promising results, safety of use, ease of application and relatively low cost. Further research is still required in order to provide evidence-based recommendations regarding the use of SDF in arresting early childhood caries. Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
- Conditions
- Early Childhood Caries
- Being tested
- SDF, ART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SDFDrug
Also called Silver Diamine Fluoride
SDF promotes enamel and dentin remineralization, as well as inhibit the growth of cariogenic bacteria. the Food and Drug Administration (FDA) approved SDF as a device for reducing tooth sensitivity in the USA.
ARTProcedure or surgery
The ART technique involves caries excavation by hand instruments only with care to avoid pulp exposure. Such excavation is mainly from the periphery of the lesion to achieve a good seal of the restoration and minimize leakage. The tooth is then restored by glass ionomer cement.
| Study group | Role | What they receive |
|---|---|---|
| Silver Diamine Fluoride | Experimental | * Gross debris will be removed with cotton pellets to allow better SDF contact with denatured dentin.
* Cotton rolls will be used to protect surrounding gingival tissues and mucous membranes to avoid pigmentation or irritation.
* Affected tooth surfaces will be dried with a gentle flow of air.
* 1-2 drops only of SDF will be used for the whole visit.
* SDF will then be directly applied to affected tooth surfaces only using a micro sponge brush.
* At least one minute will be needed to allow drying of SDF.
* Excess SDF will finally be removed with cotton rolls to minimize systemic absorption.
* When possible, isolation will be continued for up to three minutes.
* After 2-4 weeks: reapplication will be done only to lesions that do not appear arrested (dark and hard). Receives: Drug: SDF |
| Atraumatic Restorative Treatment | Active comparator | Caries removal by hand instruments with care not to expose the pulp.
* Maximum excavation from the periphery of lesions will be done, to minimize leakage at the restoration margins.
* Cotton roll isolation will then be carried out.
* Cavities will be restored by glass ionomer cement.
* Hand pressure should be applied by a gloved and petroleum jelly coated finger, then, excess material will be removed. Receives: Procedure: ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in clinical success/failure rate
Treated teeth in both groups will be evaluated for clinical success in each follow up appointment. The number of clinically successful/failed teeth will be recorded in
Measured: at 6 and 12 months
Secondary outcomes (2)
Duration of the intervention visit
time spent during each intervention appointment was calculated in seconds
Measured: During the procedure
Patient Satisfaction
using a 4-item, 5-level, Likert-scale questionnaire o assess feelings about the application procedure.
Measured: after the 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start1 Jan 2018
- Primary completion8 Apr 2019
- Study completion23 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514094
- Sponsor's protocol ID
- SDF Trials
- Status last verified
- Aug 2020
- First submitted
- 13 Aug 2020
- Last updated
- 14 Aug 2020
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Silver Diamine Fluoride in Arresting Early Childhood Caries: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04514094
- Acronym / sponsor ID
- SDF Trials
- Conditions
- Early Childhood Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 8 Apr 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 14 Aug 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.
The study was conducted to evaluate the effectiveness of the biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
Detailed description
Owing to the virulent nature of early childhood caries (ECC) and its consequences if left untreated, immediate intervention is indicated to control the condition.
Barriers to intervention as young age, uncooperative patient behavior and lack of access to dental care are however, very common. The use of silver diamine fluoride as an anticaries agent is of growing popularity worldwide due to its promising results, safety of use, ease of application and relatively low cost. Further research is still required in order to provide evidence-based recommendations regarding the use of SDF in arresting early childhood caries. Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride in arresting early childhood caries when compared to atraumatic restorative treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Silver Diamine Fluoride | Experimental | Drug: SDF* Gross debris will be removed with cotton pellets to allow better SDF contact with denatured dentin. * Cotton rolls will be used to protect surrounding gingival tissues and mucous membranes to avoid pigmentation or irritation. * Affected tooth surfaces will be dried with a gentle flow of air. * 1-2 drops only of SDF will be used for the whole visit. * SDF will then be directly applied to affected tooth surfaces only using a micro sponge brush. * At least one minute will be needed to allow drying of SDF. * Excess SDF will finally be removed with cotton rolls to minimize systemic absorption. * When possible, isolation will be continued for up to three minutes. * After 2-4 weeks: reapplication will be done only to lesions that do not appear arrested (dark and hard). |
| Atraumatic Restorative Treatment | Active comparator | Procedure: ARTCaries removal by hand instruments with care not to expose the pulp. * Maximum excavation from the periphery of lesions will be done, to minimize leakage at the restoration margins. * Cotton roll isolation will then be carried out. * Cavities will be restored by glass ionomer cement. * Hand pressure should be applied by a gloved and petroleum jelly coated finger, then, excess material will be removed. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- For children:
- Teeth with active dentin lesions corresponding to ICDAS II score 5 and 6.
- Teeth having lesions that are considered active according to ICDAS II activity criteria for coronal primary caries.
Key exclusion criteria (7 listed)
- For children:
- Clinical or radiographic signs of pulpal involvement.(pain, abscess, sinus, obvious discoloration, premature hypermobility, internal or external root resorption).
- Teeth with inactive lesions.
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 |
|---|---|---|
| SDFAlso: Silver Diamine FluorideSDF promotes enamel and dentin remineralization, as well as inhibit the growth of cariogenic bacteria. the Food and Drug Administration (FDA) approved SDF as a device for reducing tooth sensitivity in the USA. | Drug | Silver Diamine Fluoride |
| ARTThe ART technique involves caries excavation by hand instruments only with care to avoid pulp exposure. Such excavation is mainly from the periphery of the lesion to achieve a good seal of the restoration and minimize leakage. The tooth is then restored by glass ionomer cement. | Procedure or surgery | Atraumatic Restorative Treatment |
Primary outcome
change in clinical success/failure rate
Time frame: at 6 and 12 months
Treated teeth in both groups will be evaluated for clinical success in each follow up appointment. The number of clinically successful/failed teeth will be recorded in
2 secondary outcomes
Duration of the intervention visit
Time frame: During the procedure
Patient Satisfaction
Time frame: after the 4th week
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 14 Aug 2020.
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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 study testing SDF and ART in people with Early Childhood Caries, run by Hams Hamed Abdelrahman 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 7 inclusion and 7 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 14 Aug 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 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.
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 clinical success/failure rate (time frame: at 6 and 12 months). 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 14 Aug 2020.