GC EUROPE G-aenial Bond - Manual (Page 33)

33 G-ænial Bond Technical Manual
9.0 clinical Study
9.1 class V clinical Study
Study conducted by Professor M. Ferrari, University Siena, Italy
Purpose: Post-operative sensitivity is a common complication when class V restorations are placed
on vital teeth. the aim of the first part of this prospective clinical trial was to evaluate the early
post-operative sensitivity of class V restorations placed using GBa 400, available commercially
under the brand name G-ænial Bond, in combination with Gradia Direct loFlo. the aim of the
second part of this clinical study was to evaluate clinical parameters of class V restorations at 1, 1.5,
2, 3, 4 and 5 years. Results are currently available at 18 months post-placement.
materials and methods: Forty patients were selected who required at least one and no more than
two restorations. a total of 50 restorations were made. 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 was measured utilizing a
simple response-based pain scale. Pain responses to a one-second application of air from a dental
unit syringe, 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, after 1 day, 1
week and 1 month for post-operative sensitivity, marginal discolouration, marginal integrity,
secondary caries and fractures. the other clinical parameters evaluated were vitality and retention.
clinical parameters were also evaluated for the second part of the study at 1 year and 18 months.
Results: Seven of fifty preparations showed moderate sensitivity at baseline before placing
restorations and 2 remained sensitive immediately after placing the restorations. Post-operative
sensitivity diminished and had completely disappeared by the 7-day recall. after 18 months, all fifty
restorations scored alpha for the tested parameters.
conclusion: The combination of G-ænial Bond and Gradia Direct LoFlo resulted in no post-
operative sensitivity at 18 months post-placement and the marginal integrity was excellent
for all restorations.
table 7: 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
18 months recall
G-ænial Bond [n=50]
alpha bravo charlie delta
marginal discoloration and integrity 50 50 0 0 0
Secondary caries 50 50 0 0 0
Vitality test 50 50 0 0 0
Retention 50 50 0 0 0
Fracture 50 50 0 0 0
no Yes mean SD
Post-operative sensitivity 50 50 0 0 0