NCT02887456

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

August 10, 2017

Status Verified

August 1, 2017

Enrollment Period

9 months

First QC Date

June 14, 2016

Last Update Submit

August 8, 2017

Conditions

Teeth, Endodontically-Treated

Outcome Measures

Primary Outcomes (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.

    3 months

Study Arms (2)

Vitapex

ACTIVE COMPARATOR

Endodontic treatment using Vitapex

Drug: Endodontic treatment using Vitapex

MTA paste

EXPERIMENTAL

Endodontic treatment using MTA paste

Drug: Endodontic treatment using MTA paste

Interventions

Endodontic treatment using VitapexDRUG

Endodontic treatment using Vitapex

Vitapex
Endodontic treatment using MTA pasteDRUG

Endodontic treatment using MTA paste

MTA paste

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmela Bresolin

São Paulo, 05850010, Brazil

Location

Related Publications (12)

  • 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: 3468139BACKGROUND

  • 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: 6934178BACKGROUND

  • 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.

    PMID: 22484870BACKGROUND

  • 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.

    PMID: 18389674BACKGROUND

  • 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.

    PMID: 17262146BACKGROUND

  • 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.

    PMID: 2656788BACKGROUND

  • 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.

    PMID: 11132515RESULT

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

    PMID: 5263926RESULT

  • 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.

    PMID: 26792964RESULT

  • 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.

    PMID: 26687126RESULT

  • 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.

    PMID: 22536587RESULT

  • 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.

    PMID: 15525310RESULT

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Carmela Bresolin

    Faculdade de Odontologia da USP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor

Study Record Dates

First Submitted

June 14, 2016

First Posted

September 2, 2016

Study Start

September 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

August 10, 2017

Record last verified: 2017-08

Locations

BR(1)