Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste
Primary Purpose
Teeth, Endodontically-Treated
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Endodontic treatment using Vitapex
Endodontic treatment using MTA paste
Sponsored by
About this trial
This is an interventional treatment trial for Teeth, Endodontically-Treated
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
Sites / Locations
- Carmela Bresolin
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Vitapex
MTA paste
Arm Description
Endodontic treatment using Vitapex
Endodontic treatment using MTA paste
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02887456
Brief Title
Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste
Official Title
Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste - Protocol of a Phase 2 Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth, Endodontically-Treated
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitapex
Arm Type
Active Comparator
Arm Description
Endodontic treatment using Vitapex
Arm Title
MTA paste
Arm Type
Experimental
Arm Description
Endodontic treatment using MTA paste
Intervention Type
Drug
Intervention Name(s)
Endodontic treatment using Vitapex
Intervention Description
Endodontic treatment using Vitapex
Intervention Type
Drug
Intervention Name(s)
Endodontic treatment using MTA paste
Intervention Description
Endodontic treatment using MTA paste
Primary Outcome Measure Information:
Title
Success or failure of endodontic treatments
Description
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.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmela Bresolin
Organizational Affiliation
Faculdade de Odontologia da USP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carmela Bresolin
City
São Paulo
ZIP/Postal Code
05850010
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
3468139
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.
Results Reference
background
PubMed Identifier
6934178
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. No abstract available.
Results Reference
background
PubMed Identifier
22484870
Citation
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.
Results Reference
background
PubMed Identifier
18389674
Citation
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.
Results Reference
background
PubMed Identifier
17262146
Citation
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.
Results Reference
background
PubMed Identifier
2656788
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.
Results Reference
background
PubMed Identifier
11132515
Citation
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.
Results Reference
result
PubMed Identifier
5263926
Citation
Kopel HM. Root canal therapy for primary teeth. J Mich State Dent Assoc. 1970 Feb;52(2):28-33 passim. No abstract available.
Results Reference
result
PubMed Identifier
26792964
Citation
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.
Results Reference
result
PubMed Identifier
26687126
Citation
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.
Results Reference
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PubMed Identifier
22536587
Citation
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.
Results Reference
result
PubMed Identifier
15525310
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. doi: 10.1111/j.1365-263X.2004.00544.x.
Results Reference
result
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Endodontic Treatment of Primary Teeth Using Mineral Trioxide Aggregate Paste
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