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IRCT20201104049255N1 IRCT 2021-05-08 Babol University of Medical Sciences Comparison of anticandidal efficacy of Silver Diamine Fluoride and Chlorhexidine in children with severe early childhood caries Comparison of anticandidal efficacy of Silver Diamine Fluoride and Chlorhexidine in children with severe early childhood caries 2021-06-04 anticipated 30 Complete https://irct.ir/trial/54787 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The selected children were allocated into the 2 treatment groups by block randomization, through the generation of random allocation sequence using free website of "www.randomization.com", by pediatric section secretary. Allocation concealment was achieved with numbered, opaque and sealed envelopes containing the treatment allocation cards, which were prepared before the trial, Blinding description: Allocation concealment was achieved with numbered, opaque and sealed envelopes containing the treatment allocation cards, which were prepared before the trial. all dental plaque samples will be delivered to the lab with defined name tags (which only main researcher of the study is aware of) and there is no information about treatment group attached to the sample tubes. this way the researcher who evaluates outcome and data analyzer stay blind. according to apparent different format of study drugs (solution vs gel) and also possibility of staining of decayed teeth after fluoride therapy with SDF, blinding of main researcher or study patients would not be possible. 4 Severe early childhood caries. Intervention 1: Intervention group: Single topical treatment with 38% Silver Diamine Fluoride solution (Fagamin , Tedequim Argentina). Intervention 2: Control group: Single topical treatment with 1% Chlorhexidine gel (Corsodyl , GlaxoSmithKline U.K.). Yes - There is a plan to make this available What will be shared: antifungal effects od siver diamine fluoride all collected deidentified IPD are would be shared When: The data will become available 6 months after publication To whom: people working in businesses can also apply to receive it Conditions: people working in businesses can apply to receive the data to update their policies in producing caries preventive materials Where to obtain: mina yazdizadeh DDs E-mail: mn.yazdizadeh@gmail.com How to obtain: one would have access to the data around 1 month after requesting via email Comments:
public Mina Yazdizadeh
Babol Dental Faculty, Babol University of Medical Sciences, Felestin Square, Nooshirvani Blvd, Babol, Iran
Babol Iran (Islamic Republic of) 4717643633 +98 11 3229 1408 Mn.yazdizadeh@gmail.com Babol University of Medical Sciences scientific Nilgoon Pasdar
Babol Dental Faculty, Babol University of Medical Sciences, Felestin Square, Nooshirvani Blvd, Babol, Iran
Babol Iran (Islamic Republic of) 4717643633 +98 11 3229 1408 Nilgoonpasdar@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Children younger than 5 years old Children with severe early childhood caries (according to defs scale) Healthy children with no systemic condition Children with positive Candida albicans culture of dental plaque no limit 5 years Both Children who underwent either antibiotic, antifungal or fluoride therapy (systemic or topical) within the last 1 month prior to the study children with orthodontic or prosthodontic appliances special health care needs children children with no written informed consent granted K02.9 Dental caries, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Single topical treatment with 38% Silver Diamine Fluoride solution (Fagamin , Tedequim Argentina) Control group: Single topical treatment with 1% Chlorhexidine gel (Corsodyl , GlaxoSmithKline U.K.) Dental plaque Candida albicans colony count 2 and 30 days after treatment. Timepoint: Dental plaque colony count of Candida at beginning of the study (before the intervention) and 2 and 30 days after treatment with Silver Diamine Fluoride or Chlorhexidine. Method of measurement: candida colony count. Babol University of Medical Sciences Approved 2021-03-13 Ethics committee of Babol University of Medical Sciences Babol Dental Faculty, Felestin Square, Nooshirvani Blvd, Babol, Iran Babol Mazandaran Iran (Islamic Republic of)