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Stainless Steel Crowns Versus Bulkfill Composite Resin for Restoring Primary Molars After Endodontic Treatment

NCT03186950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2020-04-07

No results posted yet for this study

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%.

Conditions

  • Dental Caries

Interventions

PROCEDURE

Restoration with Stainless Steel Crowns

After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using Stainless Steel Crowns.

PROCEDURE

Restoration using BulkFill CR

After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using BulkFill composite resin

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Daniela P Raggio, Professor · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-07-31
Completion
2019-07-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03186950 on ClinicalTrials.gov