GC EUROPE G-aenial Bond - Manual (Page 34)

34 G-ænial Bond Technical Manual
9.2 class ii clinical Study
Study conducted by Professor M. Ferrari, University Siena, Italy
Purpose: the aim of this clinical study was to evaluate the post-operative sensitivity and clinical
performance of class ii restorations placed using GBa 400, commercially available under the brand
name G-ænial Bond, in combination GDlS-200 resin composite, commercially available under the
brand name Kalore.
materials and methods: Patients were selected who required at least one and no more than two
restorations. a total of 40 restorations were placed using the material combination GBa 400 and
GDlS 200. the restorations were placed between September 2008 and December 2008. adhesive
procedures were performed following the manufacturer’s instructions. Before applying the bonding
material, pain due to sensitivity was measured utilizing a simple response-based pain scale. Pain
responses to a one-second application of air from a dental unit syringe (at 40-65 psi and
approximately 20ºc), directed perpendicular to the root surface at a distance of 2 cm, as well as to
tactile stimuli with a sharp #5 explorer were determined. the restorations were placed by the same
operator, while the clinical evaluations at recall visits were performed by a second operator (double
blind approach). the restorations were evaluated immediately following placement and at day 1
and day 7, then after 1 and 12 months, for post-operative sensitivity, marginal discolouration,
marginal integrity, secondary caries, maintenance of interproximal contacts and fractures. the
other clinical parameters evaluated were vitality and retention.
Results: Seven of forty preparations showed moderate sensitivity at baseline before restorations
were placed, and 1 remained sensitive immediately after placing the restoration. Post-operative
sensitivity progressively reduced over time and had completely disappeared by the one-year recall.
after 12 months, all forty restorations scored alpha for the tested parameters.
conclusion: The combination of GBA (commercial name G-ænial Bond) and GDLS 200
(commercial name Kalore) resulted in no post-operative sensitivity and demonstrated perfect
marginal integrity 1-year post-placement.
table 8: Performance criteria according to Ryge. For post-operative sensitivity, mean value and standard deviation is provided
(1 = lowest sensitivity, 10 = highest sensitivity). Source: Adapted excerpt from Prof. M. Ferrari, University of Siena, Italy, 2010
criteria and number of restorations evaluated at
1-year recall
GBA 400 [n=40]
alpha bravo charlie delta
marginal discoloration and integrity 40 40 0 0 0
Secondary caries 40 40 0 0 0
Vitality test 40 40 0 0 0
interproximal contacts 40 40 0 0 0
Retention 40 40 0 0 0
Fracture 40 40 0 0 0
no Yes mean SD
Post-operative sensitivity 40 40 0 0 0