Evaluating the Performance and Efficiency of Zirconia Crowns in Treating Primary Teeth
Condition: Primary Teeth
Study type: Interventional

Summary: 
      This randomized clinical trial aims to compare the clinical outcomes of two
      full-coronal-coverage restorations (locally-made preformed Zirconia crowns [LMP] and NuSmile
      Zirconia crowns [Nu/ZR]) in treating carious primary teeth. Amongst the children attending
      the clinics of the Dental School at Damascus University, the ones having an indication for
      crowns restorations will be screened and if they are conformant to the inclusion criteria
      then they will be recruited until 60 teeth are reached (30 teeth for LMP/ZR restorations and
      30 for Nu/ZR restorations).
    

Detailed description: 
      This randomized clinical trial compares the clinical outcomes of using two full-coronal
      zirconia restorations (locally-made preformed zirconia crowns, and NuSmile zirconia crowns)
      in treating carious primary teeth. Children attending to the clinics of the Faculty of
      Dentistry - Damascus University and who happen to be in need for dental restorations will be
      screened for the study's inclusion criteria till 60 teeth are recruited (30 teeth for locally
      made preformed zirconia crowns restorations and 30 for NuSmile zirconia crowns restorations).
      One crown only will be used for each patient (totally 60 patients) to ensure equalizing the
      variables for both groups. The randomization will be done using SPSS software version 20.0
      (Armonk, NY; IBM Corp., USA). The study is going to be a double-blinded study (Patients
      blinding and Outcomes-assessor blinding). Simple descriptive statistics will be used for the
      analysis, also using Wilcoxon Signed-Rank test. The level of significance will be set at (α =
      0.05) and the level of confidence at (95%). The intervention is preparing primary molars
      which have one or more indications for crowning, and according to manufacturer instructions.
      Then following up the treated primary molars for 1 month, 3 months, and 6 months intervals.
      The main goals are measuring and comparing the status of the gingiva and any improvements in
      the gingival health relative to the intervention, the plaque retention in regard to the
      gingival response to the material of restoration, and also the crowns resistance to changes,
      despite its high cost.
    

Intervention name(s): Locally Made Zirconia Crowns; ZR Zirconia Crwons NuSmile ® Crowns
Intervention type(s): Device; Device
Intervention description(s): Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. Locally Made Zirconia Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).; Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. ZR Zirconia Crwons NuSmile ® Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Primary posterior teeth; zirconia crown