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Teeth, Endodontically-TreatedPhase 2NCT02887456

Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste

A Phase 2 study testing Endodontic treatment using Vitapex and Endodontic treatment using MTA paste in people with Teeth, Endodontically-Treated, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The maintenance of primary teeth until their exfoliation has been one of the main purposes of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the permanent dentition. Read more about this study

Who is it for?
Ages 3 to 7 years
Conditions the study is for
Teeth, Endodontically-Treated
What is being tested?
Endodontic treatment using Vitapex and Endodontic treatment using MTA paste
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteBrazil
Study dates
Sep 2016to Jun 2017
Phase
Phase 2
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

  • Primary teeth with pulp diagnosis and need endodontic treatment
  • Patients whose guardians consent to their participation in the survey
  • fistula or abscess
  • bone rarefaction or visual diagnosis
  • teeth in the remaining tooth structure and location of the injury rehabilitation permit do not have internal or external resorption involving more than one third of the root length
  • have no bone loss in lateral root and disruption crypt and the presence of at least half of root

Who cannot join

  • health problems systemic
  • congenital facial deformities
  • facial tumors
  • syndromes

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Carmela Bresolin

    São Paulo, 05850010

Other trials in Brazil

About this study

Official title: Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste - Protocol of a Phase 2 Randomized Clinical Trial

The maintenance of primary teeth until their exfoliation has been one of the main purposes of Pediatric Dentistry, are they representing the fundamental basis for proper occlusion of the permanent dentition. Often, injuries or extensive dental caries reach the pulp of deciduous teeth making maintenance on these dependent endodontic treatment arc. Thus, this study was to conduct a randomized clinical trial is to evaluate the performance of endodontic treatment in primary teeth using MTA paste, comparing to Vitapex.

Read the detailed description

After approval by the ethics committee of the patients Faculty of Dentistry, University of São Paulo that having root canal filling of primary teeth will be invited to participate in the study. A clinical examination and prior radiographic diagnosis will be-held. The patient will be randomized to one of two groups and will be made the endodontics by a dentist. The patient will be accompanied with periods of one week, one month and three months by a blinded evaluator. The outcome will be the success or failure of endodontic treatments evaluated through permanent tooth in the arch on clinical and radiographic conditions of normality. The longevity of the treatments will be evaluated by estimating survival rates by Kaplan-Meier. The differences between the survival rates according to the type of proposed endodontic treatment will be analyzed using the log-rank test with a minimum significance level of 5%.

Being tested
Endodontic treatment using Vitapex, Endodontic treatment using MTA paste
Medical subject headings
Tooth, Nonvital

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endodontic treatment using VitapexDrug

    Endodontic treatment using Vitapex

  • Endodontic treatment using MTA pasteDrug

    Endodontic treatment using MTA paste

Study groups in NCT02887456
Study groupRoleWhat they receive
VitapexActive comparatorEndodontic treatment using Vitapex
Receives: Drug: Endodontic treatment using Vitapex
MTA pasteExperimentalEndodontic treatment using MTA paste
Receives: Drug: Endodontic treatment using MTA paste

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Success or failure of endodontic treatments

    The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality, able to maintain or restore the health of periodical tissues after the treatment. Clinical criteria for determining success are: absence of fistula, absence of painful symptoms and pathological absence of adequate mobility and gingival contour. Radiographically, the success criteria are: absence / reduction of periapical bone rarefaction in anterior and absence / bone rarefaction in the furcation area of later, maintaining the periradicular space, root resorption compatible with the eruptive phase and absence of pathological bone resorption. To evaluate the reduction of lesions or appearance of new lesions will be between the initial and follow-up radiographs. Radiographs will be scanned and the end of the bone rarefactions starting area and will be measured on a software image analysis.

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionJun 2017
  4. Study completionJun 2017

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02887456
Sponsor's protocol ID
EndoMTA
Status last verified
Aug 2017
First submitted
14 Jun 2016
Last updated
10 Aug 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 3468139

  • 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.

    PubMed 6934178

  • Mello-Moura AC, Fanaro J, Nicoletti MA, Mendes FM, Wanderley MT, Guedes-Pinto AC. Variability in the proportion of components of iodoform-based Guedes-Pinto paste mixed by dental students and pediatric dentists. Indian J Dent Res. 2011 Nov-Dec;22(6):781-5. doi: 10.4103/0970-9290.94668.

    PubMed 22484870

  • Cerqueira DF, Mello-Moura AC, Santos EM, Guedes-Pinto AC. Cytotoxicity, histopathological, microbiological and clinical aspects of an endodontic iodoform-based paste used in pediatric dentistry: a review. J Clin Pediatr Dent. 2008 Winter;32(2):105-10. doi: 10.17796/jcpd.32.2.k1wx5571h2w85430.

    PubMed 18389674

  • Amorim Lde F, Toledo OA, Estrela CR, Decurcio Dde A, Estrela C. Antimicrobial analysis of different root canal filling pastes used in pediatric dentistry by two experimental methods. Braz Dent J. 2006;17(4):317-22. doi: 10.1590/s0103-64402006000400010.

    PubMed 17262146

  • Mass E, Zilberman UL. Endodontic treatment of infected primary teeth, using Maisto's paste. ASDC J Dent Child. 1989 Mar-Apr;56(2):117-20.

    PubMed 2656788

  • Nurko C, Ranly DM, Garcia-Godoy F, Lakshmyya KN. Resorption of a calcium hydroxide/iodoform paste (Vitapex) in root canal therapy for primary teeth: a case report. Pediatr Dent. 2000 Nov-Dec;22(6):517-20.

    PubMed 11132515

  • Kopel HM. Root canal therapy for primary teeth. J Mich State Dent Assoc. 1970 Feb;52(2):28-33 passim. No abstract available.

    PubMed 5263926

  • George S, Anandaraj S, Issac JS, John SA, Harris A. Rotary endodontics in primary teeth - A review. Saudi Dent J. 2016 Jan;28(1):12-7. doi: 10.1016/j.sdentj.2015.08.004. Epub 2015 Nov 22.

    PubMed 26792964

  • Wong AW, Tsang CS, Zhang S, Li KY, Zhang C, Chu CH. Treatment outcomes of single-visit versus multiple-visit non-surgical endodontic therapy: a randomised clinical trial. BMC Oral Health. 2015 Dec 19;15:162. doi: 10.1186/s12903-015-0148-x.

    PubMed 26687126

  • Moskovitz M, Tickotsky N, Ashkar H, Holan G. Degree of root resorption after root canal treatment with iodoform-containing filling material in primary molars. Quintessence Int. 2012 May;43(5):361-8.

    PubMed 22536587

  • Mortazavi M, Mesbahi M. Comparison of zinc oxide and eugenol, and Vitapex for root canal treatment of necrotic primary teeth. Int J Paediatr Dent. 2004 Nov;14(6):417-24. doi: 10.1111/j.1365-263X.2004.00544.x.

    PubMed 15525310

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Endodontic treatment using Vitapex and Endodontic treatment using MTA paste in people with Teeth, Endodontically-Treated, 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 6 inclusion and 4 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 10 Aug 2017. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Success or failure of endodontic treatments (time frame: 3 months). 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 NCT02887456, which also lists 12 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 10 Aug 2017.

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