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IRCT20220425054647N1 IRCT 2022-09-24 Bojnourd University of Medical Sciences effect of silver diamine fluoride in arresting proximal caries of deciduous molars comparison of the effectiveness of silver diamine fluoride with fluoride varnish in arresting proximal caries of deciduous molars 2022-09-23 anticipated 100 Complete https://irct.ir/trial/63168 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: In this study, the design will be split-mouth, Randomization description: simple randomization two envelope with number 1 and 2 are prepared and every participant choose one envelope randomly number 1 (SDF on the right tooth and varnish flouride on the loft) number 2 ( varnish flouride on the right tooth and SDF on the left), Blinding description: Both intervention groups are performed on one person (split mouth) who is not aware of difference of the intervention group. Clinical examinations and radiographs are performed by one of the researchers who is blind to the study groups. N/A dental caries. Intervention 1: Intervention group: applying one drop of 30% silver diamine fluoride (Biodinamica, Brazil) with fine microbrush on the targeted surface area and waiting for 3 minute then clear excess. Intervention 2: Control group: applying 5% sodium fuoride varnish (Centrix, America) with fine brush on the targeted surface area. Yes - There is a plan to make this available What will be shared: Participants data file, study protocol, statistical analysis map, informed consent form, clinical study report When: one year To whom: Applicants Conditions: Continue research Where to obtain: Principal investigator How to obtain: Submit request then review Comments:
public Afsoon Motallebi
Bojnourd North Khorasan dentistry school
Bojnourd Iran (Islamic Republic of) 9414665373 +98 58 3225 9729 motallebiafsoon@gmail.com Bojnourd University of Medical Sciences scientific Afsoon Motallebi
Bojnourd North Khorasan dentistry school
Bojnourd Iran (Islamic Republic of) 9414665373 +98 58 3225 9729 motallebiafsoon@gmail.com Bojnourd University of Medical Sciences Iran (Islamic Republic of) children have at least one untreated proximal caries lesion on the first or second deciduous molars in every side of jaw(split mouth) Based on clinical examinations and bite-wing radiographs, caries is limited to external one-third of the dentin. children between 3 to 6 years old 3 years 6 years Both Children with systemic diseases Children who themselves or their parents do not want to intervene Sensitivity to silver or other heavy metal ions Existence of gingival ulcers or lesions around the mouth Evidence of pulp involvement (radiographic evidence or clinical signs such as abscess) K02.6 Dental caries on smooth surface Prevention Prevention Intervention group: applying one drop of 30% silver diamine fluoride (Biodinamica, Brazil) with fine microbrush on the targeted surface area and waiting for 3 minute then clear excess Control group: applying 5% sodium fuoride varnish (Centrix, America) with fine brush on the targeted surface area. Tooth decay score based on ICDAS and ICCMS indices. Timepoint: Indices code at the beginning of the study and 6 months later. Method of measurement: Clinical and radiographic examination based on indices: International Caries Detection and Assessment System (ICDAS) و The International Caries Classification and Management System (ICCMS). Bojnourd University of Medical Sciences Approved 2022-08-28 Ethics committee of North Khorasan University of Medical Sciences bojnourd dental university bojnourd North Khorasan Iran (Islamic Republic of)