RCT: Effectiveness of a Microscope During Dental Root Apical Surgery
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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. |
- 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 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
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| Contact: M.H.T. de Ruiter, Drs. | m.h.deruiter@amc.nl |
| Netherlands | |
| Academic Medical Center; Clinic of Oral and Maxillofacial Surgery | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Principal Investigator: M.H.T. de Ruiter, Drs. | |
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 1, 2013 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) |
ClinicalTrials.gov processed this record on May 16, 2013