ART and Hall Technique for Management of Occlusal-proximal Caries in Primary Molars
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this, two-arm, parallel group, patient-randomised controlled, superiority trial is
      to evaluate the survival rate of approximal Atraumatic Restorative Treatment (ART)
      restorations compared to the Hall Technique (HT) placed in a school setting. The
      investigators will recruit 120 schoolchildren (5-10 years) with at least one
      occlusal-proximal carious lesion in primary molar. They will be randomized and treated
      following best-practice protocols to either receive an ART restoration using the
      high-viscosity glass ionomer cement (EQUIA Forte, capsules, GC Corp.) or a preformed metal
      crown placed using the HT (3M ESPE) cemented with glass ionomer luting cement (Fuji I
      Capsules, GC Corp.). Baseline measures and outcome data (at reviews over a three year period)
      will be assessed through participant report, clinical examination and parent report/
      questionnaires.
    

Detailed description: 
      The selected children will be randomly allocated into 2 groups. The control group will
      comprise cavities treated by ART, following the protocol proposed by Frencken and Holmgren
      (1999), while the experimental group will comprise cavities treated by HT, according to the
      guideline published by Innes and Evans (2011). The allocation of patients in each group will
      be carried out by a random list generated by a specific computer program. To ensure the
      allocation concealment, the sequence generated by randomization will be distributed in
      opaque, sealed envelopes, which will be opened by the operator during the treatment, only
      after the patient is ready to receive treatment.

      Operators will be two undergraduate students in dentistry and one experienced specialist in
      pediatric dentistry that will be trained on how to prepare and fill the cavities according to
      the original procedures of ART (Frencken and Holmgren, 1999) and also according to HT (Innes
      and Evans, 2011). The training will include a lecture about the techniques used in this
      study, as well as a workshop held in the laboratory for students to train handling and
      application of treatments to be tested. They will also undergo a week of training with
      patients, to apply the different techniques before starting the study, the latter phase held
      at the Faculty of Dentistry, University of São Paulo, under the supervision of an experienced
      dentist in ART and HT.

      Each child will be allocated for one of the operators with the aid of a random list. All
      treatments will be performed on the school premises, in field conditions without the use of
      dental chair or other facilities from a clinical environment.
    

Intervention name(s): Atraumatic Restorative Treatment; Hall Technique
Intervention type(s): Procedure; Procedure
Intervention description(s): No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed.; It employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss.
Other intervention name(s): Equia Forte; Metal Crowns
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atraumatic Restorative Treatment; Occlusoproximal; Primary Teeth; Glass Ionomer Cements; Hall Technique