Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth. Clinical Trial
Official title:
The Effectiveness of a Microscope During Apical Surgery; a Prospective Randomized Controlled Clinical Trial.
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).
| Status | Recruiting |
| Enrollment | 190 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Academic Medical Center; Clinic of Oral and Maxillofacial Surgery | Amsterdam |
| Lead Sponsor | Collaborator |
|---|---|
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Success is measured by Clinical outcome and radiographic assessment. | 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. | 6 months and 1 year | No |