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

NCT02216942 | Completed Phase 3

• 1 other identifier: FOUSP2408
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Endodontic Treatment of Primary Teeth

Keywords

Endodontics; Deciduous teeth; Iodoform pastes; Treatment Refusal

Outcome Measures

Primary Outcomes (1)

• Success or failure of two endodontic treatments

  The success or failure of endodontic treatments evaluated by the time spent in the tooth arch in clinical conditions of normality. 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.

  two years

Secondary Outcomes (1)

• Quality of the obturation obtained with the two root canal filling pastes

  two years

Study Arms (2)

Vitapex

ACTIVE COMPARATOR

Endodontic treatment using Vitapex

Drug: Endodontic treatment using Vitapex

Guedes Pinto Paste

EXPERIMENTAL

Endodontic treatment using Guedes Pinto

Drug: Endodontic treatment using Guedes Pinto

Interventions

Endodontic treatment using Vitapex DRUG

Endodontic treatment using Vitapex

Vitapex

Endodontic treatment using Guedes Pinto DRUG

Endodontic treatment using Guedes Pinto paste

Guedes Pinto Paste

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (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

Sponsors & Collaborators

• Fausto Medeiros Mendes: lead

Study Sites (1)

Carmela Bresolin

São Paulo, 05850010, Brazil

Location

Related Publications (18)

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

  PMID: 5263926 BACKGROUND

• 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: 3468139 BACKGROUND

• 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: 6934178 BACKGROUND

• 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.

  PMID: 6960030 BACKGROUND

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

  PMID: 10925773 BACKGROUND

• 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.

  PMID: 1629445 BACKGROUND

• 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: 2656788 BACKGROUND

• 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.

  PMID: 16430526 BACKGROUND

• 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.

  PMID: 11310245 BACKGROUND

• 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.

  PMID: 8015949 BACKGROUND

• 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.

  PMID: 10826052 BACKGROUND

• 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: 17262146 BACKGROUND

• 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: 15525310 BACKGROUND

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

  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.

  PMID: 6943625 RESULT

• 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.

  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.

  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.

  PMID: 11132515 RESULT

MeSH Terms

Conditions

Treatment Refusal

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Carmela Bresolin, PHD student

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fausto Medeiros Mendes

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: August 15, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: February 1, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

BR (1)