NCT03453658|Completed
Mechanized Instrumentation for Endodontic Treatment of Primary Teeth
Evaluation of Mechanized Instrumentation for Endodontic Treatment of Primary Teeth - Randomized Clinical Trial
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Evaluation of Mechanized Instrumentation for Endodontic Treatment of Primary Teeth - Randomized Clinical Trial
Sponsor study identifier
interventional
151
1 country
1
Study Start
November 8, 2017
Actual (reported)Primary Completion
August 31, 2018
Actual (reported)Study Completion
January 28, 2021
Actual (reported)Mechanized instrumentation systems stand out amongst various devices used in modern Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the center of many discussions and laboratory studies. Nevertheless, up to now, a lack of clinical studies on this issue can be found. Our objective is to conduct a double blinded, 2 years follow up clinical trial to compare the success of endodontic treatment in primary teeth using mechanized reciprocating instrumentation to the use of manual instrumentation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 28, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 8, 2017
Actual (reported)February 27, 2018
Actual (reported)March 5, 2018
Actual (reported)August 31, 2018
Actual (reported)January 28, 2021
Actual (reported)Success or failure of endodontic treatment
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
Appointment duration
After treatment
Quality of obturation provided by two different instrumentation techniques
After treatment
Discomfort related to each instrumentation technique
After treatment.
Cost-Efficacy of each instrumentation technique
Two years
Manual instrumentation: Endodontic treatment will be performed with the use of conventional endodontic manual files.
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.
Manual conventional files will be used in endodontic treatment of primary teeth
Reciprocating files system will be used in endodontic treatment of primary teeth.
School of Dentistry, University of Sao Paulo
São Paulo, 05508-000, Brazil
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.
Renata Marques, PhD Student
University of Sao Paulo
151 participants (actual enrollment reported by the registry).
First Submitted
February 27, 2018
First Posted
March 5, 2018
Study Start
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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November 8, 2017
Actual (reported)Primary Completion
August 31, 2018
Actual (reported)Study Completion
January 28, 2021
Actual (reported)Last Updated
March 24, 2021
Record last verified: 2021-03
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