Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04848987 |
Other study ID # |
A10150421 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 10, 2016 |
Est. completion date |
September 10, 2020 |
Study information
Verified date |
April 2021 |
Source |
Mansoura University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The present study was designed to provide further evidence in this particular research
prospective, and this study hence aimed to clinically evaluate the 5-years adhesion
durability of indirect resin composite inlays luted with three different resin cement
strategies in MOD Class II restorations. The formulated null hypothesis was that there is no
significant difference in the clinical performances of the three different resin cement
strategies for luting indirect resin composite inlays in MOD Class II restorations for
5-years.
The research question was as follows: Do self-adhesive resin cements in class II restorations
present better clinical performances than conventional etch-and-rinse and self-etch resin
cements according to the USPHS criteria?
Description:
Objective: To clinically evaluate the 5 years adhesion durability of indirect resin composite
inlays luted with three different resin cement strategies in MOD Class II restorations.
Materials and Methods: A randomized clinical trial was conducted following the protocol, 40
patients with three large cavities for each one that indicated for indirect MOD Class II
restorations were enrolled in the current study. Then, 120 indirect resin composite inlay
restorations (SR Nexco) were placed and luted with three different resin cement strategies;
an etch-and-rinse (Variolink N), self-etch (Panavia F2.0) and self-adhesive (RelyX Unicem).
Each resin cement was used for luting 20 inlay restorations. A single operator placed all
restorations according to the manufacturer's instructions. Immediatelly after placement, the
restorations were finished and polished. Clinical evaluation was performed at baseline and at
1, 3 and 5 years intervals after placement by two independent examiners using modified USPHS
criteria. The changes in the USPHS parameters during the 5 years period were analyzed with
Fredman test. The baseline scores were compared with those at the recall visits using
Wilcoxon signed rank test, where the level of significance was set at p˂0.05.