Other Unsatisfactory Restoration of Tooth Clinical Trial
Official title:
Phase 3- Clinical Trial on Children. PROTOCOL 465-549
Preformed stainless steel crowns have been used in Pediatric Dentistry to restore badly
broken down primary teeth since 1950. They are generally considered more expedient to place
than large multi-surface amalgam or composite restorations and have a longer life. They have
been used successfully in clinical practice for many years and have presented little in the
way of adverse events. The major drawback is the poor esthetics along with lingering concerns
over potential health hazards associated with the nickel content. Several attempts have been
made to improve upon the esthetics of stainless steel crowns such as veneering the buccal and
occlusal surfaces and substituting composite resin for the entire crown, but to date none of
these approaches have been very successful.
Acetal resin has been used in a number of applications in medicine and dentistry, and
recently has met with early success when tested as a substitute for stainless steel crowns.
It has a number of excellent physical and mechanical properties including a low coefficient
of friction, good wear resistance, high fatigue resistance, good impact strength and
resistance to creep.
The purpose of this trial is to compare the clinical performance of preformed acetal resin
crowns and preformed stainless steel crowns.
2.0 OBJECTIVES
The objective of this study is to compare the clinical performance of acetal resin crowns
with preformed stainless steel crowns when used to restore primary molar teeth.
STUDY POPULATION
A minimum of 25 subjects contributing a minimum of 40 acetal crowns ( on primary molar teeth
will be recruited from the patient pool of the pediatric dentistry clinic at Barzilai Medical
Center, Ashkelon and enrolled into the study. A maximum of four crowns will be placed in any
subject. It is estimated that it will take approximately 14 weeks to place all crowns and
complete the baseline examination.
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