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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Procedure: Restoration using BulkFill CR; Procedure: Restoration with Stainless Steel Crowns

• Registration Number: NCT03186950
• Lead Sponsor: University of Sao Paulo

Brief 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%.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-13
• Study First Submitted QC: 2017-06-13
• Study First Posted: 2017-06-14
• Primary Completion: 2017-07
• Study Completion: 2019-07-10
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-05
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Remaining tooth structure and location of the lesion allow rehabilitation
• Do not have internal or external resorption involving more than 1/3 the length of the root
• Do not have bone loss in lateral root or crypt disruption
• With the presence of at least half of the root

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Exclusion Criteria

• patients that do not fit the inclusion criteria
• patients whos parents did not sign the assentiment term
• patients with systemic desease

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restoration using BulkFill CR	Restoration using BulkFill CR	Restoration of the tooth after endodontic treatment using bulkfill composite resin
Restoration with Stainless Steel Crowns	Restoration with Stainless Steel Crowns	Restoration of the tooth after endodontic treatment using stainless steel crown.

Primary Outcome Measures

Name	Time	Method
Endodontic Treatment survival	12 months	The primary outcome will be the success or failure of endodontic treatments evaluated through the tooth permanence in the arcade on clinical and radiographic conditions of normality compared between groups restorations (steel crown or composite).; The clinical criteria to determine success are: absence of fistula, absence of painful symptoms, absence of pathological mobility and adequate gingival contour. Radiographically, the success criteria are: absence / reduction of rarefaction and absence / bone thinning in the furcation region later, maintenance of periradicular space, root resorption compatible with eruptive phase and absence of pathological resorption
Need for new intervention	12 months	It will be assess the need for any type of reintervention, both for the steel crown group and for the composite resin. Thus, our primary outcome will be measured in accordance with the evaluation of restorations, not only by the failure or not endodontic treatment.; Clinical sucess: no fistulae or abscess Radiographic sucess: Reduction or maintenance of the interradicular lesion; No crypt breakup

Secondary Outcome Measures

Name	Time	Method
Cost-efficacy between the groups	baseline, 1, 6, 12 and 24 months	The cost effectiveness of the restoration will be evaluated through consultation that will be timed and cost form developed for the study.
Acceptance of the treatments	Baseline	Evaluate the acceptance of the treatments by the patients and their guardians, using a questionnaire.

Trial Locations

Locations (1)

University of São Paulo - School of Dentistry; 🇧🇷 São Paulo, Brazil