An interventional study of SDF and ART in Early Childhood Caries, sponsored by Hams Hamed Abdelrahman. Completed at 1 site in Egypt. Open to participants aged 2 Years to 5 Years. Per ClinicalTrials.gov, last updated 2020-08-14.
Sponsored by Hams Hamed Abdelrahman · Not applicable, Interventional, and Treatment
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.
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.
Hams Hamed Abdelrahman is the lead sponsor of 107 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For children:
For teeth:
Exclusion Criteria:
For children:
For teeth:
* 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).
Drug: SDF
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.
Procedure: ART
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.
Also known as: Silver Diamine Fluoride
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.
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
Time frame: at 6 and 12 months
Duration of the intervention visit
time spent during each intervention appointment was calculated in seconds
Time frame: During the procedure
Patient Satisfaction
using a 4-item, 5-level, Likert-scale questionnaire o assess feelings about the application procedure.
Time frame: after the 4th week
This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Hams Hamed Abdelrahman