Comparison of Silver Modified and Conventional Atraumatic Restorative Treatment Modalities
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is a randomized controlled trial aiming to compare the effectiveness of Silver
      modified atraumatic restorative technique and (SMART) and conventional atraumatic restorative
      technique (ART) regarding their caries arresting properties in primary molars, patient
      acceptance and cost effectiveness.
    

Detailed description: 
      5-9 years old school children will be recruited for the study. Parents of eligible children
      will be informed in full details about the purpose of the study and any possible side
      effects. Prior to enrollment of children in the study, parents will have to sign a written
      informed consent outlined by the Ethical Committee, Faculty of Dentistry, Ain Shams
      University. Children will be also informed about the nature of the study using age
      appropriate language and will have to give an assent to participate before being enrolled in
      the study.

      Children will be clinically examined with the help of a plane dental mirror and an explorer.
      A single calibrated investigator will undertake all clinical examinations and deliver dental
      treatment to all patients to ensure standardization. After clinical examination, all children
      included in the study will be randomly allocated to be one of the two groups either control
      group (Conventional ART) or experimental group (SMART). Randomization sequence will be
      electronically generated using (http://randomization.com/). To ensure concealment of
      allocation, the randomly generated sequence will be concealed and enclosed in sealed, opaque
      envelopes. The envelopes will be randomly picked up by the children for group allocation.
      Follow up examinations will be done by a calibrated examiner who was not involved in the
      treatment procedures. Patients who are no longer willing to continue in the study will have
      the right to quit at any time without any penalty. All patient information will be collected
      and recorded in the patient examination chart. All information will be kept as a hard copy
      and as an electronic copy as well. Patient information will be confidential information that
      should never be exposed at any point. The data concerning the subjects will be entered into
      the database with a numerical code only for the purpose of confidentiality.

      All data will be tabulated, summarized and statistically analyzed. Data will be statistically
      described in terms of mean, standard deviation, median and range, or frequencies (number of
      cases) and percentages when appropriate.

      Comparison of numerical variables between the study groups will be done using Student t test
      for independent samples in comparing normally distributed data and Mann Whitney U test for
      independent samples when data is not normally distributed. For comparing categorical data,
      Chi-square test will be performed. Exact test will be used instead when the expected
      frequency is less than 5.Correlation between various variables will be done using Pearson
      moment correlation equation for linear relation in normally distributed variables and
      Spearman rank correlation equation for non-normal variables.

      A probability value (p value) less than 0.05 is considered statistically significant. All
      statistical calculations will be done using computer programs Microsoft Excel 2007 (Microsoft
      Corporation, NY, USA) and IBM SPSS (Statistical Package for the Social Science; IBM Corp,
      Armonk, NY, USA) release 22 for Microsoft Windows.
    

Intervention name(s): Silver diamine Fluoride 38%; Conventional atraumatic restorative treatment
Intervention type(s): Drug; Procedure
Intervention description(s): In the intervention group 38% Silver Diamine Fluoride will be applied to the surface of the isolated lesion for a period of 1 minute followed by glass ionomer restoration at the same visit.; In the active comparator group caries will be removed from primary molars using sharp excavators then teeth will be restored using glass ionomer filling material at the same visit.
Other intervention name(s): Advantage Arrest Silver diamine Fluoride 38%; ART
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment