GC EUROPE Kalore - Manual (Page 30)

30 GC Kalore technical manual
9.0 Clinical investigations
Post-operative sensitivity and other clinical parameters of Class II made with KALORE resin
composite after one year of clinical service.
Ferrari M, Cagidiaco MC, Chazine M., Paragliola R, Grandini S. University of Siena, Italy.
Purpose: the aim of this clinical study was to evaluate the post-operative sensitivity and clinical
performance of class ii restorations made with KalORe resin composite in combination with
G-BOND™.
materials and methods: Patients were selected who required either one or two restorations. a total
of 40 restorations were placed. Adhesive procedures were performed in accordance with the
manufacturer’s instructions. Before applying the bonding material, pain was measured utilizing a
simple response-based pain scale. Response was determined 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. The restorations
were placed by the same operator, while the clinical evaluations at recall visits were made 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 discoloration, marginal integrity, secondary caries, maintenance of interproximal contacts
and fractures. the other evaluated clinical parameters were vitality and retention.
Results: three preparations showed moderate sensitivity at baseline before placing restorations
(table 10). Post-operative sensitivity progressively reduced over time and had completely
disappeared by the 1-year recall. after one year, only two restorations presented with marginal
discoloration (1 alpha, 1 beta score).
Conclusion: The combination of G-BOND and KALORE resulted in no post-operative sensitivity 1
year post-placement.
table 10: Performance criteria according to Ryge. For post-operative sensitivities, mean value and standard deviation is
provided (1 = lowest sensitivity, 10 = highest sensitivity).
test criteria and number of restorations
evaluated at 1-year recall
G-BOND and KALORE [n=40]
alpha Bravo charlie delta
marginal discolorations and integrity 38 1 1 0 0
Secondary caries 40 0 0 0 0
Vitality test 40 0 0 0 0
Interproximal contacts 40 0 0 0 0
Retention 40 0 0 0 0
Fracture 40 0 0 0 00
Post-operative sensitivities no Yes mean SD
40 40 0 0 0