Reasons for Termination of Study

Reasons for Termination of Study

After submission of the July '99 summary (30 months), it was noticed that only six patients out of twenty-three patients were recalled. Sargon asked to check the study patients and patient records.

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  • USC attorneys replied, by asking Sargon to provide them with a copy of protocol section E.
  • Sargon propounded an inspection demand requiring USC to produce Sargon with copies of all patient records.
  • Sargon was given by the USC attorneys a set of charts prepared for litigation. When these were produced, Sargon objected and demanded USC to provide a complete copy of patient records.
  • After patient records were checked, it was discovered that not only patients were not given any incentives to come back, many patients were charged almost full price.
  • Patient records indicate that at least one patient was denied restoration of their implant because of an outstanding balance. This was done not withstanding one of goals of this research was to show that patients could be in their definitive restoration in four weeks (patient #1, Protocol Background/Introduction). Also, as seen in Appendix C of the research protocol, Sargon had already made payment toward these restorations.
  • The medical charts revealed that patients were subjected to serious violations of the
  • Sargon restorative and surgical protocol.
  • Patient records were also altered to hide all surgical and prosthetic errors and to support manufactured radiolucencies reported in the July summary. (Confirmed by the attached expert lab report)