Phase 2 Clinical Study :Evaluation of the Efficacy of Insoluble Antibacterial Nanoparticles Incorporated Into Commercialy Used Composit Resins as an Esthetic Restoration Material in Children

Composite resins are presently among the most popular esthetic restorative materials in dentistry. These materials offer excellent esthetic appearance, allow for conservative cavity preparation and are now becoming widely accepted for clinical use in primary molars 1-23. Despite the improvement of their properties, achieved with better materials and incremental placing techniques, composite resin restorations appear to have still several drawbacks: although similar to amalgam in short terms studies, they have a high long term failure rate, mainly due to discoloration, loss of retention and secondary caries3,11,19, are time-consuming and technique sensitive, lack anti-cariogenic potential and can be amenable to secondary caries at the cervical dentin margins 1, 2.

Continued interest in providing advance in restorative esthetic materials led to the development of new generations of composites. Among the newest material developed is the use of minute amount of nanoparticles which convert composites to possess permanent antibacterial properties.

It is of great interest to observe the clinical behavior of this new material when utilized in clinical practice. Thus the aims of the present in-vivo study are:

1. To evaluate the clinical and radiographic performance of the New Restorative System when placed with adhesive systems in class II restorations of primary molars.
2. To assess, by SEM, the micromorphology of the cervical, buccal and lingual margins of the proximal surfaces of the restored teeth retrieved after exfoliation or extraction.
3. To asses, by means of polarized light microscopy, the integrity of the cervical margins of the same retrieved teeth.

STUDY DESIGN The study will be performed at the Post Graduate Clinic of the Pediatric Dentistry Department of the Hadassah School of Dental Medicine in Jerusalem. The project will have to be approved by the Human Ethical Committee (Helsinki), at the Hadassah Hospital and by the Israeli Ministry of Health.