Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste

NCT ID: NCT02887456

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-06-30

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.

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%.

Conditions

Teeth, Endodontically-Treated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vitapex

Endodontic treatment using Vitapex

Group Type: ACTIVE_COMPARATOR

Endodontic treatment using Vitapex

Intervention Type: DRUG

Endodontic treatment using Vitapex

MTA paste

Endodontic treatment using MTA paste

Group Type: EXPERIMENTAL

Endodontic treatment using MTA paste

Intervention Type: DRUG

Endodontic treatment using MTA paste

Interventions

Endodontic treatment using Vitapex

Endodontic treatment using Vitapex

Intervention Type: DRUG

Endodontic treatment using MTA paste

Endodontic treatment using MTA paste

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fausto Medeiros Mendes

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carmela Bresolin

Role: PRINCIPAL_INVESTIGATOR

Faculdade de Odontologia da USP

Locations

Carmela Bresolin

São Paulo, , Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

PMID: 3468139 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 6934178 (View on PubMed)

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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: RESULT

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

Reference Type: RESULT

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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.

Reference Type: RESULT

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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.

Reference Type: RESULT

PMID: 26687126 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22536587 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15525310 (View on PubMed)

Other Identifiers

EndoMTA

Identifier Type: -

Identifier Source: org_study_id