RCT: Effectiveness of a Microscope During Dental Root Apical Surgery

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Unknown status
CT.gov ID
NCT01759069
Collaborator
(none)
190
1
2
39
4.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical treatment with microscope
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
190 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Effectiveness of a Microscope During Apical Surgery; a Prospective Randomized Controlled Clinical Trial.
Study Start Date :
Sep 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment with microscope

treatment with microscope

Procedure: Surgical treatment with microscope

Experimental: treatment without microscope

treatment without microscope

Procedure: Surgical treatment with microscope

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Academic Medical Center; Clinic of Oral and Maxillofacial Surgery Amsterdam Netherlands 1105 AZ

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
M.H.T. de Ruiter, Resident/PhD student at dept. of Oral and Maxillofacial Surgery, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01759069
Other Study ID Numbers:
  • Microscope
First Posted:
Jan 2, 2013
Last Update Posted:
Jan 20, 2014
Last Verified:
Jan 1, 2014

Study Results

No Results Posted as of Jan 20, 2014