Objective: To determine in subhuman primates the biocompatibility of Activa BioActive Cement, a resin modified glass ionomer, using either the light curing (Gr. 1) or auto-polymerizing method (Gr. 2). Recommended Standard Practices for Biological Evaluation of Dental Materials, Document No. 41 were followed.
Method: Two
rhesus macaques were sedated with ketamine 10mg/kg i.m. with further anesthesia through Septocain 4% 1:100.000. Pre-and postoperative radiographs were obtained. Cl V inlay preparations were made for each group (n=10) for a 30-day and 100-day observation. Composite resin inlays were fabricated and cemented. Controls from previous experiments were used. After perfusion euthanasia, continued fixation in 10% buffered formalin and decalcification the teeth were prepared for histological evaluation. 6 micron thick sections were cut and stained with H&E. ANOVA for the RDT and Kruskal-Wallis were used for statistical analysis.
Result:
|
RDT mm
|
Asp.Nucl
|
Superf
|
Deep resp
|
Hyperemia
|
Rep. dent
|
|
Mean
|
0-3
|
0-4 A/C/M
|
0-4 A/C/M
|
0-3
|
mm
|
Gr. 1:30d
|
0.46
|
0
|
1.8/C
|
1/C
|
0.75
|
0.13
|
Gr. 2:30d
|
0.62
|
0
|
1.6/C
|
1.5/C
|
1.37
|
0
|
Gr. 1:100d
|
0.52
|
0
|
0.25/C
|
0
|
0.25
|
0.2
|
Gr. 2:100d
|
0.48
|
0
|
0.86/C
|
0.43
|
0.57
|
0.1
|
No statistical difference was observed for the RDT between the 2 groups of each time period (p<0.05). Furthermore the inflammatory response between the two time periods was significant (p<0.05) with a diminishing superficial and deep inflammatory response. The experimental material performed better than the control (ZOE). Conclusion: Over time the irritation of an RMGI reached acceptable levels and can be considered biocompatible. (In part supported by Pulpdent Corp)