Mechanized Instrumentation for Endodontic Treatment of Primary Teeth
NCT ID: NCT03453658
Last Updated: 2021-03-24
Study Results
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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COMPLETED
NA
151 participants
INTERVENTIONAL
2017-11-08
2021-01-28
Brief Summary
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Detailed Description
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The primary outcome of the study will be the success rates according to the groups. The longevity of treatments will be evaluated by estimating survival rates by Kaplan-Meier and Cox regression. The differences between survival rates of both groups will be through Cox regression adjusted for the cluster nature of the sample (more than one tooth per participant), considering a level of significance of 5%.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Manual instrumentation
Manual instrumentation: Endodontic treatment will be performed with the use of conventional endodontic manual files.
Manual instrumentation
Manual conventional files will be used in endodontic treatment of primary teeth
Reciprocating instrumentation
Mechanized instrumentation: Endodontic treatment will be performed with the use of reciprocating mechanized files. The files are activated by an engine that produces reciprocating movements.
Reciprocating Instrumentation
Reciprocating files system will be used in endodontic treatment of primary teeth.
Interventions
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Manual instrumentation
Manual conventional files will be used in endodontic treatment of primary teeth
Reciprocating Instrumentation
Reciprocating files system will be used in endodontic treatment of primary teeth.
Eligibility Criteria
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Inclusion Criteria
* Patients whose parents or guardians consent to their participation in the study
Exclusion Criteria
* Resorption of more than 2/3 of the root
* Destruction of the crypt of the permanent successor
* Pulp chamber floor drilling.
* Presence of internal resorption
3 Years
9 Years
ALL
Yes
Sponsors
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University of Sao Paulo
OTHER
Responsible Party
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Fausto Medeiros Mendes
Associate professor
Principal Investigators
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Renata Marques, PhD Student
Role: PRINCIPAL_INVESTIGATOR
University of Sao Paulo
Locations
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School of Dentistry, University of Sao Paulo
São Paulo, , Brazil
Countries
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References
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Ahmad IA, Pani SC. Accuracy of electronic apex locators in primary teeth: a meta-analysis. Int Endod J. 2015 Mar;48(3):298-307. doi: 10.1111/iej.12315. Epub 2014 Jun 28.
Ahmed HM. Anatomical challenges, electronic working length determination and current developments in root canal preparation of primary molar teeth. Int Endod J. 2013 Nov;46(11):1011-22. doi: 10.1111/iej.12134. Epub 2013 May 25.
Canoglu H, Tekcicek MU, Cehreli ZC. Comparison of conventional, rotary, and ultrasonic preparation, different final irrigation regimens, and 2 sealers in primary molar root canal therapy. Pediatr Dent. 2006 Nov-Dec;28(6):518-23.
Fumes AC, Sousa-Neto MD, Leoni GB, Versiani MA, da Silva LA, da Silva RA, Consolaro A. Root canal morphology of primary molars: a micro-computed tomography study. Eur Arch Paediatr Dent. 2014 Oct;15(5):317-26. doi: 10.1007/s40368-014-0117-0. Epub 2014 Feb 22.
Kummer TR, Calvo MC, Cordeiro MM, de Sousa Vieira R, de Carvalho Rocha MJ. Ex vivo study of manual and rotary instrumentation techniques in human primary teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Apr;105(4):e84-92. doi: 10.1016/j.tripleo.2007.12.008.
Fuks AB. Pulp therapy for the primary and young permanent dentitions. Dent Clin North Am. 2000 Jul;44(3):571-96, vii.
Lee GH, McGrath C, Yiu CK. Developing clinical practice guidelines for caries prevention and management for pre-school children through the ADAPTE process and Delphi consensus. Health Res Policy Syst. 2016 Jun 14;14(1):44. doi: 10.1186/s12961-016-0117-0.
Moura-Netto C, Palo RM, Pinto LF, Mello-Moura AC, Daltoe G, Wilhelmsen NS. CT study of the performance of reciprocating and oscillatory motions in flattened root canal areas. Braz Oral Res. 2015;29:1-6. doi: 10.1590/1807-3107bor-2015.vol29.0006. Epub 2014 Dec 2.
Nagaratna PJ, Shashikiran ND, Subbareddy VV. In vitro comparison of NiTi rotary instruments and stainless steel hand instruments in root canal preparations of primary and permanent molar. J Indian Soc Pedod Prev Dent. 2006 Dec;24(4):186-91. doi: 10.4103/0970-4388.28075.
Neena IE, Ananthraj A, Praveen P, Karthik V, Rani P. Comparison of digital radiography and apex locator with the conventional method in root length determination of primary teeth. J Indian Soc Pedod Prev Dent. 2011 Oct-Dec;29(4):300-4. doi: 10.4103/0970-4388.86371.
Nobrega DF, Fernandez CE, Del Bel Cury AA, Tenuta LM, Cury JA. Frequency of Fluoride Dentifrice Use and Caries Lesions Inhibition and Repair. Caries Res. 2016;50(2):133-40. doi: 10.1159/000444223. Epub 2016 Mar 19.
Pinheiro SL, Araujo G, Bincelli I, Cunha R, Bueno C. Evaluation of cleaning capacity and instrumentation time of manual, hybrid and rotary instrumentation techniques in primary molars. Int Endod J. 2012 Apr;45(4):379-85. doi: 10.1111/j.1365-2591.2011.01987.x. Epub 2011 Dec 22.
Piovesan C, Mendes FM, Ferreira FV, Guedes RS, Ardenghi TM. Socioeconomic inequalities in the distribution of dental caries in Brazilian preschool children. J Public Health Dent. 2010 Fall;70(4):319-26. doi: 10.1111/j.1752-7325.2010.00191.x.
Prabhakar AR, Yavagal C, Dixit K, Naik SV. Reciprocating vs Rotary Instrumentation in Pediatric Endodontics: Cone Beam Computed Tomographic Analysis of Deciduous Root Canals using Two Single-file Systems. Int J Clin Pediatr Dent. 2016 Jan-Mar;9(1):45-9. doi: 10.5005/jp-journals-10005-1332. Epub 2016 Apr 22.
Rasquin LC, de Carvalho FB, Lima RK. In vitro evaluation of root canal preparation using oscillatory and rotary systems in flattened root canals. J Appl Oral Sci. 2007 Feb;15(1):65-9. doi: 10.1590/s1678-77572007000100014.
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.
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.
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.
Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.
Other Identifiers
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FOUSP2912
Identifier Type: -
Identifier Source: org_study_id
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