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…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Assessment of the therapy is carried out blinded from whether a microscope
was used or not and is recorded on a screening formulary with the patients
number.
The radiological criteria as described by Rud et al in 1972 (Rud, Andreasen, &
Jensen, 1972)
are used for success:
- The lamina dura around the apex of the tooth is visible and all roots are
investigated separately.
- The periodontal space around the apex is <2 times the periodontal space at
the nontreated part of the root.
- The bone defect that was seen right after treatment is filled with new bone
that is not necessarily of the same opacity as the surrounding bone.
- A small apical defect in the lamina dura of maximal 1 mm2 at the side of the
apical filling is acceptable.
The following clinical criteria for success are formulated as:
- No fistula or pockets to the apex.
- No percussion sensitiveness of the tooth.
- Tooth is functional and without impairment or complaints.
- Aspect of scar tissue and gingival tissue (no signs of infection).
All radiographs are assessed by 2 maxillofacial surgeons who are blinded for
the possible use of a microscope during treatment at the time of assessment.
Each of the treated teeth is assessed separately. In case of a different
outcome, the assessment of a third maxillofacial surgeon is final. Only when
all criteria are positive the treatment is called successful. One year after
the last patient is included, the randomization code will be broken.
Secondary outcome
not applicable
Background 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 root-end e.g. MTA (von Arx, Hanni, & Jensen, 2010)
Study objective
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).
Study design
A prospective randomized blinded clinical trial.
Intervention
In the first group the surgeon and assistant are using a microscope for
assisting in the operation. In the second group the surgeon and assistant are
not using a microscope during treatment.
Study burden and risks
not applicable
Meibergdreef 9
1105 AZ Amsterdam
NL
Meibergdreef 9
1105 AZ Amsterdam
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL36896.018.11 |