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Completed

NCT Number: NCT03186950

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

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%.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

3 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo - School of Dentistry

São Paulo, 05508-000, Brazil

About this study

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%.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

Restoration with Stainless Steel Crowns

Procedure

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

Restoration using BulkFill CR

Procedure

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

Primary outcomes

  1. Endodontic Treatment survival

    Time frame: 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

  2. Need for new intervention

    Time frame: 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 outcomes

  1. Cost-efficacy between the groups

    Time frame: 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.

  2. Acceptance of the treatments

    Time frame: Baseline

    Evaluate the acceptance of the treatments by the patients and their guardians, using a questionnaire.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Stainless Steel Crowns Versus Bulkfill Composite Resin for Restoring Primary Molars After Endodontic Treatment: Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2019
First posted
Jun 14, 2017
Registry last updated
Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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