Abstract
GC EQUIA: Results of the prospective, randomised, blind,
clinical study in the field on EQUIA Fil – results after 12
months and initial appraisals after 24 months
Dr Th. Klinke, Prof R. Biffar,
Greifswald University Hospital,
Centre for Dental, Oral and Maxillofacial Surgery
In this prospective, randomised, blind, clinical field the issue to be
investigated is whether the two glass ionomer materials Fuji IX GP
Fast and EQUIA are clinically proven. As such, a new, Germanywide study method was used for the first time, which draws on
experiences from epidemiological research and can therefore
demonstrate routine care in dental surgeries. When recruiting from
2009 to 2011 a total of 3,194 dentists in randomly selected cities
in Germany were invited to take part in the study (duration: five
years, study administration: Klinke/Biffar, registration number at
WHO:
DRKS00004220).
Altogether,
144
dentists
agreed
to
participate in a blind study by applying randomly assigned EQUIA
or Fuji IX GP to eight patients each with fillings required in the
posterior region. It was possible to verify compliance with the
manufacturer’s recommended indications by taking impressions of
the cavities. The evaluation of fillings in the study was carried out
locally in annual recall intervals by an externally calibrated dentist
from Greifswald University, in which changes and abrasion
characteristics of the fillings were collected and recorded in photos
as well taking as impressions. For the evaluation of the fillings the
generally recommended FDI criteria of Hickel, R. et al. (2010) were
used.
Results
Of the restorations made by the practising dental surgeries, 64.9%
were within the indication. As a parameter for calculating the
likelihood of survival according to Kaplan-Meier the filling fracture
or crack was evaluated. After 12 months, in the 367 fillings within
the indication limit, no statistically significant difference could be
detected between the two treatment arms (Cox regression). All the
fillings within the recommended indications were still under risk.
Only three fillings showed partial filling fractures, but these did not
require the fillings to be replaced. Even in the yet to be concluded
follow-up examinations after 24 months of observation, does
anything look noticeably different. At the two-year stage, two
thirds of the fillings have currently been re-examined.
Discussion
These data can be used to support the statement of Basso et al.
(2011) that EQUIA is a reliable choice for long-term restorations
even when subject to masticatory forces. Basso has documented
this in a total of 245 patients over a two-year period. In addition,
the submission by Friedl, K. et al. (2011) that EQUIA is suitable as a
permanent restoration material can be confirmed for this period.
Friedl substantiates this by means of a retrospective cohort study
with a total of 43 patients in six dental surgeries and 26 class I and
125 class II cavities with an average time in situ of 24 months. The
data we have collected show the restoration routine. Even under
these conditions and in compliance with the recommended
indications, no adverse behaviour by the latest generation of glass
ionomer fillings is anticipated.
Conclusion
This means practising dentists are now being given a material for
basic restoration that represents a good alternative to amalgam
and more expensive composite restorations for small single surface
and small double surface restorations in the indication area
described.
You can find further reference material on the storage device
enclosed in the press kit.
Dr Th. Klinke, Prof R. Biffar
Greifswald University Hospital
Centre for Dental, Oral and Maxillofacial Surgery
Walther-Rathenau-Strasse 42a
17475 Greifswald
klinke@uni-greifswald.de
biffar@uni-greifswald.de