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

Endodontic Treatment of Primary Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216942
• Other study ID #: FOUSP2408
• Status: Completed
• Phase: Phase 3
• First received: August 12, 2014
• Last updated: February 27, 2018
• Start date: January 2015
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 2018
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Endodontic Treatment of Primary Teeth

Intervention

Drug:
• Endodontic treatment using Vitapex
Endodontic treatment using Vitapex
• Endodontic treatment using Guedes Pinto
Endodontic treatment using Guedes Pinto paste

Locations

Country	Name	City	State
Brazil	Carmela Bresolin	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Fausto Medeiros Mendes

Country where clinical trial is conducted

Brazil, 

References & Publications (18)

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.

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.

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. — View Citation

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

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

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. — View Citation

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. Portuguese. — View Citation

Kopel HM. Root canal therapy for primary teeth. J Mich State Dent Assoc. 1970 Feb;52(2):28-33 passim. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Nurko C, Ranly DM, García-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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Wright KJ, Barbosa SV, Araki K, Spångberg 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. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of the obturation obtained with the two root canal filling pastes	The quality of the filling will be assessed by a blinded examiner according to two criteria. Through an index that ranks the shutter in satisfactory, questionable or unsatisfactory and through evaluation of digital radiographic images with the aid of a computational tool (Autodesk AutoCAD), where the visible areas of the root canal will be measured in previous radiographic examination and their measurements of the area of the root canal filling pastes filled with channels. The influence of the quality of the filling in the successful treatment will also be assessed.	two years