Preformed Pediatric Crown Zirconia Versus Preformed Pediatric Metal Crown
Condition: Tooth Decay
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Preformed metal pediatric crowns (PPCm) are currently considered the best method of restoring
      Primary molars affected by severe carious lesions compared to restorations made with various
      restorative materials (amalgams, composites, CVI-based materials). Due to their unsightly
      appearance, denounced by many parents, more aesthetic zirconia (PPCz) preformed pediatric
      crowns have been recently marketed. In the absence of an evaluation of the latter, this
      multi-center split-mouth two-year randomized clinical trial (RCT) proposes to to investigate
      the effectiveness of PPCz for the management of dental caries or structural anomalies. More
      specifically, the primary objective of this RCT is to assess in primary molars the success of
      PPCz in comparison with PPCm. The control treatment will be PPCm since this is the standard
      crown option.

      One hundred children and one aged at least 4 years must be recruited in ninedepartments of
      Pediatric Dentistry in the university hospitals of Bordeaux, Lille, Nancy, Nantes, Nice,
      Paris 1&2, Strasbourg and Toulouse. They will be included if they have two similar
      primarymolars of the same arch (for example first right and left maxillary primary molars )
      and equally affected, to be crowned. The two types of crowns to be used in the same child,
      PPCm(3M Espe) and PPCz(Ezpédo), will be affected by randomization using a computerized and
      centralized system: primary molars will first be allocated to PPCm and, one to two weeks
      later, the contralateral primary molar will be restored by PPCz. The children will be checked
      every 6 months for a period of 2 years after the placement of the two types of crowns .
      During these four control visits, primary and secondary outcomes will be assessed clinically
      and radiographically. The primary outcome is the success of the treatment defined by the
      absence of major failure. A composite measure of signs and symptoms leading to diagnosis of
      irreversible pulpitis or periradicular periodontitis will be used to define major failure
      (pain, pulp infection, dental abscess, periradicular pathology visible on radiograph). The
      secondary outcomes are parental and child satisfaction (size, form and color), retention and
      fracture of the PPC, the wear of the antagonist tooth, the gingival state near PPC using the
      indices Löe and Silness to record plaque index (PI), gingival index (GI) and depth of the
      pocket (DI) on the crowned tooth and the two adjacent ones. Each center has a trained and /
      or calibrated operator and evaluator.
    


Intervention name(s): PPC z; PPC m
Intervention type(s): Device; Device
Intervention description(s): Installation of a preformed pediatric zircona crown; Installation of a preformed pediatric metal crown
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth design
Masking: None (Open Label)
Primary purpose: Treatment