Viewing Study NCT01759069


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Study NCT ID: NCT01759069
Status: UNKNOWN
Last Update Posted: 2014-01-20
First Post: 2012-12-24
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: RCT: Effectiveness of a Microscope During Dental Root Apical Surgery
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Organization:

Study Overview

Official Title: The Effectiveness of a Microscope During Apical Surgery; a Prospective Randomized Controlled Clinical Trial.
Status: UNKNOWN
Status Verified Date: 2014-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: An endodontic treatment is the standard therapy for teeth with periapical periodontitis. The overall success rate for this treatment is high; 97% of the treated teeth are retained in the oral cavity after 8 years (Salehrabi \& Rotstein, 2004). However, there are teeth that have a persistent granuloma because of various reasons and need endodontic retreatment or apical surgery. Overall results in literature for an endodontic retreatment show a success rate of 77%-89% (Ng, Mann, \& Gulabivala, 2008; Salehrabi \& Rotstein, 2010), the results of apical surgery are more or less similar (von Arx, 2005). Which of the two methods is preferred for failed root canal treatments is dependant on a variety of reasons. (For example an amount of gutta-percha outside the apex of the root is better corrected by apical surgery. Persistent infection as a result of insufficient gutta-percha amounts in a treated root is best treated with an endodontic retreatment.) The overall results in apical surgery have increased the past years due to better preparation of the apical end of the root by the use of an ultrasonic device (de Lange, Putters, Baas, \& van Ingen, 2007) and new materials that are used for filling of the rootend e.g. MTA (von Arx, Hanni, \& Jensen, 2010)

Objective of the study:

The objective of this study is to assess whether or not apical surgery that is carried out with the help of a microscope has a higher success rate than apical surgery without the use of a microscope. No RCT is found in present literature (Del Fabbro, Taschieri, Lodi, Banfi, \& Weinstein, 2009).
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: