Radiation Dosimetry in Teeth | NCT00178347

Studies
Radiation Dosimetry in Teeth

NCT00178347

Sponsor

University of Rochester

Status

Terminated

Last Update Posted

May 19, 2009Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Radiation Tolerance

Interventions

Exposure to irradiation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 15, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 15, 2009

Last Update Posted Date

May 19, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Irradiation of any tissue creates changes in that tissue. Ionizing radiation imparts charges to the tissue as it interacts with tissue components, changing the tissue structure. The specific type of modification also depends to some extent upon the type of tissue irradiated. It has been shown that it is possible to read the tooth enamel irradiation record using techniques such as electron paramagnetic resonance (EPR), or electron spin resonance (ESR).

It is proposed to examine radiation responses in approximately one hundred (100) human teeth. This would include teeth free of, as well as those containing, amalgam (silver) restorations. For the first group, teeth that have already been collected (pre-existing pathological specimens) would be used. These teeth were surgical/pathological discards collected without identifiers by the dental providers.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exposure to irradiation	Radiation	Treatment for Cancer using Radiation -dose will be the standard of Care for the type of Cancer being treated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Discarded pathologic specimens (teeth)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

discarded pathological specimen(teeth)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Okunieff, MD	University of Rochester, Dept. of Radiation Oncology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Rochester, Dept. Radiation Oncology		Rochester	New York	14642	United States