Stainless Steel Crowns Versus Bulkfill Composite Resin for Restoring Primary Molars After Endodontic Treatment
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The pulp therapy in primary teeth is designed to eliminate the infection and keep the tooth
      in a functional state until its natural exfoliation. An important step for the success of
      endodontic therapy is the final restoration, which must seal the tooth, avoiding new
      contamination. Thus, this study proposes to carry out a randomized clinical trial with
      longitudinal follow-up of two years, in order to compare the degree of success of endodontic
      treatment in primary teeth restored with two different techniques: composite resin (Filtek
      Bulk Fill - 3M ESPE) or stainless steel crowns (3M ESPE). Success will be measured by
      clinical and radiographic features of primary teeth treated with the different restorations
      after 1, 6, 12 and 24 months. Among the secondary outcomes that will be assessed are the
      quality and durability of restorations and the cost benefit of treatments. Patients who seek
      the university clinics and require endodontic treatment will be invited to participate. The
      sample unit is the tooth and these will be randomized in groups through a randomization list
      created and distributed in sequential opaque envelopes. The envelope will be opened only
      after the end of endodontic treatment, to ensure allocation concealment. The data will be
      statistically analyzed using the Stata 12.0 (Stata Corporation, College Station, TX, USA).
      The longevity of the treatments will be evaluated by estimating survival rates using the
      Kaplan-Meier method. Differences between survival rates according to the type of endodontic
      proposed treatment will be analyzed using the log-rank test. All other clinical variables
      will be analized using Cox regression. The significance level for all analyzes will be 5%.
    

Detailed description: 
      The pulp therapy in primary teeth is designed to eliminate the infection and keep the tooth
      in a functional state until its natural exfoliation. An important step for the success of
      endodontic therapy is the final restoration, which must seal the tooth, avoiding new
      contamination. Thus, this study proposes to carry out a randomized clinical trial with
      longitudinal follow-up of two years, in order to compare the degree of success of endodontic
      treatment in primary teeth restored with two different techniques: composite resin (Filtek
      Bulk Fill - 3M ESPE) or stainless steel crowns (3M ESPE). Success will be measured by
      clinical and radiographic features of primary teeth treated with the different restorations
      after 1, 6, 12 and 24 months. Among the secondary outcomes that will be assessed are the
      quality and durability of restorations and the cost benefit of treatments. Patients who seek
      the university clinics and require endodontic treatment will be invited to participate. The
      sample unit is the tooth and these will be randomized in groups through a randomization list
      created and distributed in sequential opaque envelopes. The envelope will be opened only
      after the end of endodontic treatment (made with Guedes-Pinto paste), to ensure allocation
      concealment. The data will be statistically analyzed using the Stata 12.0 (Stata Corporation,
      College Station, TX, USA). The longevity of the treatments will be evaluated by estimating
      survival rates using the Kaplan-Meier method. Differences between survival rates according to
      the type of endodontic proposed treatment will be analyzed using the log-rank test. All other
      clinical variables will be analized using Cox regression. The significance level for all
      analyzes will be 5%.
    

Intervention name(s): Restoration with Stainless Steel Crowns; Restoration using BulkFill CR
Intervention type(s): Procedure; Procedure
Intervention description(s): After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using Stainless Steel Crowns.; After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using BulkFill composite resin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment