Dental CariesNCT03186950
Stainless Steel Crowns Versus Bulkfill Composite Resin for Restoring Primary Molars After Endodontic Treatment
A study testing Restoration with Stainless Steel Crowns and Restoration using BulkFill CR in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Dental Caries
- What is being tested?
- Restoration with Stainless Steel Crowns and Restoration using BulkFill CR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2016to 10 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- patients that do not fit the inclusion criteria
- patients whos parents did not sign the assentiment term
- patients with systemic desease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of São Paulo - School of Dentistry
São Paulo, 05508-000
About this study
Official title: Stainless Steel Crowns Versus Bulkfill Composite Resin for Restoring Primary Molars After Endodontic Treatment: Randomized Clinical Trial
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%.
Read the 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%.
- Conditions
- Dental Caries
- Being tested
- Restoration with Stainless Steel Crowns, Restoration using BulkFill CR
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restoration with Stainless Steel CrownsProcedure or surgery
After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using Stainless Steel Crowns.
Restoration using BulkFill CRProcedure or surgery
After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using BulkFill composite resin
| Study group | Role | What they receive |
|---|---|---|
| Restoration with Stainless Steel Crowns | Active comparator | Restoration of the tooth after endodontic treatment using stainless steel crown. Receives: Procedure: Restoration with Stainless Steel Crowns |
| Restoration using BulkFill CR | Experimental | Restoration of the tooth after endodontic treatment using bulkfill composite resin Receives: Procedure: Restoration using BulkFill CR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Secondary outcomes (2)
Cost-efficacy between the groups
The cost effectiveness of the restoration will be evaluated through consultation that will be timed and cost form developed for the study.
Measured: baseline, 1, 6, 12 and 24 months
Acceptance of the treatments
Evaluate the acceptance of the treatments by the patients and their guardians, using a questionnaire.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2017
- Study startJul 2016
- Primary completionJul 2017
- Study completion10 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Prócida Raggio, University of Sao Paulo
- Investigators
- Daniela P Raggio, Professor, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03186950
- Sponsor's protocol ID
- ENDOREST
- Status last verified
- Apr 2020
- First submitted
- 13 Jul 2016
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Coll JA, Sadrian R. Predicting pulpectomy success and its relationship to exfoliation and succedaneous dentition. Pediatr Dent. 1996 Jan-Feb;18(1):57-63.
PubMed 8668572Garcia-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.
PubMed 3468139Rifkin 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.
PubMed 6934178Rifkin 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.
PubMed 6960030
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stainless Steel Crowns Versus Bulkfill Composite Resin for Restoring Primary Molars After Endodontic Treatment: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03186950
- Acronym / sponsor ID
- ENDOREST
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- 10 Jul 2019 (actual)
- First posted
- 14 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restoration with Stainless Steel Crowns | Active comparator | Procedure: Restoration with Stainless Steel CrownsRestoration of the tooth after endodontic treatment using stainless steel crown. |
| Restoration using BulkFill CR | Experimental | Procedure: Restoration using BulkFill CRRestoration of the tooth after endodontic treatment using bulkfill composite resin |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- patients that do not fit the inclusion criteria
- patients whos parents did not sign the assentiment term
- patients with systemic desease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restoration with Stainless Steel CrownsAfter finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using Stainless Steel Crowns. | Procedure or surgery | Restoration with Stainless Steel Crowns |
| Restoration using BulkFill CRAfter finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using BulkFill composite resin | Procedure or surgery | Restoration using BulkFill CR |
Primary outcome
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
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
2 secondary outcomes
Cost-efficacy between the groups
Time frame: baseline, 1, 6, 12 and 24 months
Acceptance of the treatments
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Background: PubMed 8668572Coll JA, Sadrian R. Predicting pulpectomy success and its relationship to exfoliation and succedaneous dentition. Pediatr Dent. 1996 Jan-Feb;18(1):57-63.
- Background: PubMed 3468139Garcia-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.
- Background: PubMed 6934178Rifkin 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.
- Background: PubMed 6960030Rifkin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela P Raggio, Professor principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restoration with Stainless Steel Crowns and Restoration using BulkFill CR in people with Dental Caries, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endodontic Treatment survival (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03186950, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.