Endodontic Treatment of Necrotic Primary Teeth With Guedes Pinto Paste: A Randomized Clinical Trial

NCT ID: NCT02216942

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2018-02-28

Brief Summary

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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 with longitudinal follow-up of two years, double blind, to compare the degree of success of endodontic treatment in primary among the most used folder, Guedes Pinto paste, and one Calcium hydroxide and iodoform paste to control, Vitapex.

Detailed Description

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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 and also a quality of life questionnaire regarding oral health (- ECOHIS Early Childhood Oral Health Impact Scale) will be-held. The patient will be randomized to one of two groups and will be held endodontics by a blind handler. The patient will be accompanied with periods of one week, six months, 12 months and 24 months by a blinded evaluator. At the last visit of the review ECOHIS questionnaire will be reapplied to those responsible. 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

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Endodontic Treatment of Primary Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitapex

Endodontic treatment using Vitapex

Group Type ACTIVE_COMPARATOR

Endodontic treatment using Vitapex

Intervention Type DRUG

Endodontic treatment using Vitapex

Guedes Pinto Paste

Endodontic treatment using Guedes Pinto

Group Type EXPERIMENTAL

Endodontic treatment using Guedes Pinto

Intervention Type DRUG

Endodontic treatment using Guedes Pinto paste

Interventions

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Endodontic treatment using Vitapex

Endodontic treatment using Vitapex

Intervention Type DRUG

Endodontic treatment using Guedes Pinto

Endodontic treatment using Guedes Pinto paste

Intervention Type DRUG

Eligibility Criteria

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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

1 Year

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fausto Medeiros Mendes

OTHER

Sponsor Role lead

Responsible Party

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Fausto Medeiros Mendes

Fausto Medeiros Mendes

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Carmela Bresolin, PHD student

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Carmela Bresolin

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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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 BACKGROUND
PMID: 5263926 (View on PubMed)

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.

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)

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.

Reference Type BACKGROUND
PMID: 6960030 (View on PubMed)

Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2000 Jul;44(3):571-96, vii.

Reference Type BACKGROUND
PMID: 10925773 (View on PubMed)

Kubota K, Golden BE, Penugonda B. Root canal filling materials for primary teeth: a review of the literature. ASDC J Dent Child. 1992 May-Jun;59(3):225-7.

Reference Type BACKGROUND
PMID: 1629445 (View on PubMed)

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
PMID: 2656788 (View on PubMed)

Srinivasan V, Patchett CL, Waterhouse PJ. Is there life after Buckley's Formocresol? Part I -- a narrative review of alternative interventions and materials. Int J Paediatr Dent. 2006 Mar;16(2):117-27. doi: 10.1111/j.1365-263X.2006.00688.x.

Reference Type BACKGROUND
PMID: 16430526 (View on PubMed)

Waterhouse PJ, Nunn JH, Whitworth JM, Soames JV. Primary molar pulp therapy--histological evaluation of failure. Int J Paediatr Dent. 2000 Dec;10(4):313-21. doi: 10.1046/j.1365-263x.2000.00211.x.

Reference Type BACKGROUND
PMID: 11310245 (View on PubMed)

Wright KJ, Barbosa SV, Araki K, Spangberg LS. In vitro antimicrobial and cytotoxic effects of Kri 1 paste and zinc oxide-eugenol used in primary tooth pulpectomies. Pediatr Dent. 1994 Mar-Apr;16(2):102-6.

Reference Type BACKGROUND
PMID: 8015949 (View on PubMed)

Mani SA, Chawla HS, Tewari A, Goyal A. Evaluation of calcium hydroxide and zinc oxide eugenol as root canal filling materials in primary teeth. ASDC J Dent Child. 2000 Mar-Apr;67(2):142-7, 83. No abstract available.

Reference Type BACKGROUND
PMID: 10826052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17262146 (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 BACKGROUND
PMID: 15525310 (View on PubMed)

Bonow MLM, Guedes-Pinto AC,Bammann LL. Antimicrobial activity of drugs used in pulp therapy of deciduous teeth. J EndodBraz, 1: 44-48, 1996

Reference Type RESULT

Guedes-Pinto AC, De Paiva JG, Bozzola JR. [Endodontic treatment of deciduous teeth with pulp necrosis]. Rev Assoc Paul Cir Dent. 1981 May-Jun;35(3):240-4. No abstract available. Portuguese.

Reference Type RESULT
PMID: 6943625 (View on PubMed)

14- Kramer PF, Faraco Junior IM, Feldens CA. Current status of pulp therapy in the Brazilian Universities - Pulpotomy and Pulpectomy Technique in deciduous teeth. J Bras Odontop e OdontolBebe, 3: 222-29, 2000.

Reference Type RESULT

16- Michel JA, Guedes-Pinto AC, AraújoVC. Estudo histopatológico da reação de subcutâneo de camundongos submetidos à ação da pasta Guedes-Pinto utilizada na terapia de dentes decíduos com polpa mortificada. RevFacOdontol São Paulo, 23: 65-72, 1980.

Reference Type RESULT

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
PMID: 11132515 (View on PubMed)

Other Identifiers

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FOUSP2408

Identifier Type: -

Identifier Source: org_study_id

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