RCT: Effectiveness of a Microscope During Dental Root Apical Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
M.H.T. de Ruiter, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01759069
First received: December 24, 2012
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effectiveness of a Microscope During Apical Surgery; a Prospective Randomized Controlled Clinical Trial.

Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Success is measured by Clinical outcome and radiographic assessment. [ Time Frame: 6 months and 1 year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 190
Study Start Date: September 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: treatment with microscope
treatment with microscope
Procedure: Surgical treatment with microscope
Experimental: treatment without microscope
treatment without microscope
Procedure: Surgical treatment with microscope

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759069

Contacts
Contact: M.H.T. de Ruiter, Drs. m.h.deruiter@amc.nl

Locations
Netherlands
Academic Medical Center; Clinic of Oral and Maxillofacial Surgery Recruiting
Amsterdam, Netherlands, 1105 AZ
Principal Investigator: M.H.T. de Ruiter, Drs.         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications 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     History of Changes
Other Study ID Numbers: Microscope
Study First Received: December 24, 2012
Last Updated: January 17, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

ClinicalTrials.gov processed this record on September 30, 2014