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Clinical Trials/NCT01759069
NCT01759069
Unknown
Not Applicable

The Effectiveness of a Microscope During Apical Surgery; a Prospective Randomized Controlled Clinical Trial.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country190 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth.
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
190
Locations
1
Primary Endpoint
Success is measured by Clinical outcome and radiographic assessment.
Last Updated
12 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
December 2015
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

M.H.T. de Ruiter

Resident/PhD student at dept. of Oral and Maxillofacial Surgery

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • Peri-apical lesion on one of the teeth, confirmed on radiograph.
  • Previous endodontic treatment was more than 6 months earlier.

Exclusion Criteria

  • Root fracture.
  • Periodontal origin of apical infection or absence of marginal buccal bone after flap elevation.
  • Root perforation.
  • No previous endodontic treatment.
  • Previous endodontic surgery.

Outcomes

Primary Outcomes

Success is measured by Clinical outcome and radiographic assessment.

Time Frame: 6 months and 1 year

A radiograph of the treated tooth is made directly post-operative, after 6 months and after 1 year post treatment. Clinical examination is performed at 6 months and 1 year after the operation.

Study Sites (1)

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