RCT: Effectiveness of a Microscope During Dental Root Apical Surgery

NCT ID: NCT01759069

Last Updated: 2014-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Effectiveness of Microscope During Apical Surgery in Endodontic Treated Teeth.

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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treatment with microscope

treatment with microscope

Group Type EXPERIMENTAL

Surgical treatment with microscope

Intervention Type PROCEDURE

treatment without microscope

treatment without microscope

Group Type EXPERIMENTAL

Surgical treatment with microscope

Intervention Type PROCEDURE

Interventions

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Surgical treatment with microscope

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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M.H.T. de Ruiter

Resident/PhD student at dept. of Oral and Maxillofacial Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Academic Medical Center; Clinic of Oral and Maxillofacial Surgery

Amsterdam, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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M.H.T. de Ruiter, Drs.

Role: CONTACT

Other Identifiers

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Microscope

Identifier Type: -

Identifier Source: org_study_id

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