RCT: Effectiveness of a Microscope During Dental Root Apical Surgery

Not Applicable

• Conditions: Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth.
• Interventions: Procedure: Surgical treatment with microscope

• Registration Number: NCT01759069
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-24
• Study First Submitted QC: 2013-01-01
• Study First Posted: 2013-01-02
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-17
• Last Update Posted: 2014-01-20
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 190

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment with microscope	Surgical treatment with microscope	treatment with microscope
treatment without microscope	Surgical treatment with microscope	treatment without microscope

Primary Outcome Measures

Name	Time	Method
Success is measured by Clinical outcome and radiographic assessment.	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.

Trial Locations

Locations (1)

Academic Medical Center; Clinic of Oral and Maxillofacial Surgery; 🇳🇱 Amsterdam, Netherlands