Occlusal ART Restorations in Primary Molars Using 3 Different GIC
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the survival rate and the cost-effectiveness of
      occlusal-ART restorations using three GIC brands (Fuji IX, GC Europe; Maxxion R, FGM; Vitro
      Molar, DFL) in primary molars.
    

Detailed description: 
      Sampling procedure:

      This study was approved by the research ethics committee of the School of Dentistry
      (University of São Paulo, Brazil) and a written informed consent will be obtained from the
      parents or legal guardians of the participating children. The sample size was calculated
      based on the minimum difference of 10% in the success rate between the control and treatment
      groups after 1 year of follow-up, with and α of 5% and power (strength) of 80% using paired
      test. According to the sample size calculation 150 children aged from 5-8 years old attending
      public schools from the city of Barueri in the state of São Paulo, Brazil will be selected.

      To be included in this study the following criteria must be followed: healthy, cooperative
      children with at least one occlusal carious lesion in a primary molar extending to the dentin
      with dimensions not greater than 2 mm occluso-cervical and with an intact edge list. Also, to
      be included the tooth cannot present ulcer, abscess, fistula, or pathological mobility.

      Implementation:

      One occlusal restoration per child will be included in this study. If the selected children
      present more cavities, they will be referred to the health centre of the municipality of
      Barueri or will be treated by the operators of this research during the training week. All
      the occlusal and proximal-ART restorations will be performed by two operators on the school
      premisses. The operators will be final year dental students who will be previously trained to
      perform ART and to mix the GIC according to the manufacturers' protocol. Additionally, a
      try-out week will be included to give the operators the opportunity to familiarise themselves
      with the local conditions prior to the start of the operative phase of the study. The
      operators will be assisted by a local dentist and a dentist assistant, who will be previously
      trained to mix the GIC according to the manufacturers' protocol. The children will be
      randomly assigned into three groups: Fuji IX, Maxxion R, and Vitro Molar and the GIC brand
      used in each child will be assigned by a random list. The operators are blind for the GIC
      brand.

      Treatment procedure:

      The ART technique will be performed according to the ART guidelines proposed by Frencken
      (2014). No local anaesthesia will be used during treatment. The plaque will be removed and an
      enamel hatchet will be used to make access to underlying softened dentine. 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 three GIC brands: Fuji IX (GC Europe, Leuven, BE), Maxxion R (FGM,
      Rio de Janeiro, BR) and Vitro Molar (DHL, Rio de Janeiro, BR). The GICs will be hand mixed
      according to the manufacturers´ instructions (powder/liquid ratio 1:1) and will be inserted
      into the cavity with a conventional application instrument. 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 stop watch. The participating children will be
      instructed not to eat for one hour after the restoration is placed.

      Estimation of cost-effectiveness:

      Effectiveness will be measured in terms of the retention rate. This study will report only
      the preliminary results after 1 month, but the other follow-ups will be done every 6 months
      up to 3 years. 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 all the three
      GIC groups and will be excluded. There will be no labour costs for the operators. The
      material cost (powder-liquid GICs) will be estimated per restoration. After this, a analysis
      for each material will be made to see the cost-effectivess between each material (all the
      materials used during the restorations) and the retention rate of the restoration.

      Evaluation:

      The retention rate of the restorations will be evaluated after 1 month according to the
      modified version of Roeleveld et al. (2006) criteria. A restoration will be considered as
      'failure' when there is a defect in the filling, when secondary caries are 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 one
      independent evaluator, who did not restore the cavities, trained and calibrated by a
      benchmark.

      The cost effectiveness will be evaluated. The total price of each GIC brand, used to insert
      into the cavities will be compared to the retention rate of the restorations.

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Intervention name(s): Restoration with Fuji IX; Restoration with Vitro Molar; Restoration with Maxxion R
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): The cavities will be restored with Fuji IX (GC Europe, Leuven, BE).; The cavities will be restored with Vitro Molar (DHL, Rio de Janeiro, BR).; The cavities will be restored with Maxxion R (FGM, Rio de Janeiro, BR).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dental atraumatic restorative treatment; primary tooth; occlusal restoration; glass-ionomer cement