Primary Molars Restorations With Encapsulated or Hand-Mixed Glass Ionomer: Clinical Trial
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this RCT is to evaluate the survival of different glass ionomer cement in
      minimally invasive restorations, with different handling characteristics: hand-mixed versus
      encapsulated.
    

Detailed description: 
      Detailed Description: This study was approved by the research ethics committee of the School
      of Dentistry (University of São Paulo, Brazil) and written informed consent will be obtained
      from the parents or legal guardians. The sample size was calculated based on the data
      obtained in a systematic review, which reported average longevity of 78% after 2 years of
      follow up (mean survival of occlusal and occlusoproximal surfaces). The minimum difference of
      15% in the success rate between the control and treatment groups after 2 years of follow-up,
      with and α of 5% and power (strength) of 80% using paired test. As more than one tooth per
      children might be included, we must add a 20% for clustering. Adding 20% for possible losses
      the final estimate is 116 teeth per group, reaching a final sample of 232 teeth.

      Inclusion Criteria:

        -  Children who have sought treatment in the School of Dentistry, University of Sao Paulo;

        -  Children between 3 and 10 years old without systemic diseases;

        -  Children presenting at least one dentin caries cavity in primary teeth (occlusal or
           oclusoproximal) with no signs of pulp involvement.

      Exclusion Criteria:

        -  Children whose parents did not agree to participate in the study;

        -  Children with behavioural issues at the initial exam or who did not assent to
           participate in the study.

      Implementation:

      All the occlusal and occlusoproximal restorations will be performed by two operators on the
      dental chair. The operators will be assisted by another dentist, who will be previously
      trained to mix the GIC according to the manufacturers' protocol. The children will be
      randomly assigned into two groups: Hand-mixed and encapsulated materials.

      Treatment procedure:

      The restorative technique will be performed according to the Minimal Intervention Dentistry.
      No local anaesthesia will be used during treatment. Rotary instruments can be used to open or
      to expand the cavity opening, removing only enamel. Infected carious dentin will be removed
      with hand instruments. The use of hand instruments on the dentin surface results in a smear
      layer and need to be removed by the use of dentine conditioner. The liquid component of the
      hand-mixed powder-liquid GIC, containing the acid component, will be used and saliva
      isolation will be done with cotton wool rolls. The cavities will be restored with one of the
      two GIC brands: Fuji IX (GC Europe, Leuven, BE) and EQUIA (GC Europe, Leuven, BE). A thin
      layer of petroleum jelly will be rubbed over the index finger and the restoration will be
      pressed for 20 seconds. The material will include sealing pits and the fissure. After
      preparing for a balanced occlusion, a new layer of petroleum jelly will be applied to the GIC
      restoration. The amount of GIC used, element number, cavity dimension and dmft will be
      recorded. The duration of the restorative procedure will be recorded with a stopwatch. The
      participating children will be instructed not to eat for one hour after the restoration is
      placed.

      Evaluation:

      The success of the restorations will be evaluated after 6 months according to the Frencken
      and Holmgren criteria for occlusal surfaces, and modified version of Roeleveld et al. (2006)
      criteria for occlusoproximal surfaces. A restoration will be considered as 'failure' when
      there is a defect in the filling when secondary caries is observed, when the restoration is
      not present or when the pulp is inflamed. When the restoration is still present or a slight
      defect is observed, it will be considered as 'success'. When the tooth is unavailable for
      evaluation, it will be censored. All evaluations will be carried out by two independent
      evaluators, who did not restore the cavities, trained and calibrated by a benchmark.

      Estimation of cost-effectiveness:

      The material cost (GICs) will be estimated per restoration. The average cost per restoration
      will be estimated. Costs of equipment, autoclave and hand instruments, disposables (hand
      gloves, face masks, cotton wool rolls), articulating paper and petroleum jelly used for the
      restorations are equal for both GIC groups and will be excluded. There will be no labour
      costs for the operators.
    

Intervention name(s): Restoration with hand-mixed material; Restoration with Encapsulated material; Encapsulated glass ionomer cement (EQUIA - GC Corp).; powder-liquid glass ionomer cement (Fuji IX - GC Corp)
Intervention type(s): Procedure; Procedure; Device; Device
Intervention description(s): restoration with hand-mixed glass ionomer cement; restoration with encapsulated ionomer cement
Other intervention name(s): Minimally invasive restoration
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: dentinal caries; occlusal; occluso-proximal