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

NCT03186950 | Completed

• 1 other identifier: ENDOREST
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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%.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (2)

• Endodontic Treatment survival

  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

  12 months

• Need for new intervention

  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

  12 months

Secondary Outcomes (2)

• Cost-efficacy between the groups

  baseline, 1, 6, 12 and 24 months

• Acceptance of the treatments

  Baseline

Study Arms (2)

Restoration with Stainless Steel Crowns

ACTIVE COMPARATOR

Restoration of the tooth after endodontic treatment using stainless steel crown.

Procedure: Restoration with Stainless Steel Crowns

Restoration using BulkFill CR

EXPERIMENTAL

Restoration of the tooth after endodontic treatment using bulkfill composite resin

Procedure: Restoration using BulkFill CR

Interventions

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 with 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

Restoration using BulkFill CR

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• patients whos parents did not sign the assentiment term
• patients with systemic desease

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo - School of Dentistry

São Paulo, 05508-000, Brazil

Location

Related Publications (4)

• Coll JA, Sadrian R. Predicting pulpectomy success and its relationship to exfoliation and succedaneous dentition. Pediatr Dent. 1996 Jan-Feb;18(1):57-63.

  PMID: 8668572 BACKGROUND

• Garcia-Godoy F. Evaluation of an iodoform paste in root canal therapy for infected primary teeth. ASDC J Dent Child. 1987 Jan-Feb;54(1):30-4.

  PMID: 3468139 BACKGROUND

• Rifkin A. A simple, effective, safe technique for the root canal treatment of abscessed primary teeth. ASDC J Dent Child. 1980 Nov-Dec;47(6):435-41. No abstract available.

  PMID: 6934178 BACKGROUND

• Rifkin A. The root canal treatment of abscessed primary teeth--a three to four year follow-up. ASDC J Dent Child. 1982 Nov-Dec;49(6):428-31. No abstract available.

  PMID: 6960030 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Daniela P Raggio, Professor

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2016
• First Posted: June 14, 2017
• Study Start: July 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 10, 2019
• Last Updated: April 7, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)