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Published: 19 years ago
 
This is a reply to # 37,535

Re: This web site may help?


We all know the Cavitat/tron is not approved and there is good reason. I happened across some of it here http://www.aetna.com/cpb/data/CPBA0642.html

I am cutting and pasting the info - very interesting reading, Although it is from an insurance company's website - it proves it is not effective treatment. Maybe someday, maybe magnets work too?, hmhm - However, I know maggots are being used, for a fact!

Also, the Cavitat has been used on the same person, within the same region, within minutes of each scan the results were different. This is a fact too, I know the PEOPLE that were duped by it. One should never put too much faith in these types of machines. Get a 3 phase Gallium Bone Scan, an MRI and yes, BLOODWORK - c reactive protein, sed rate and white blood count. then culture. just do it right or you;ll never get over it. even then, there's always a chance it will remain forever. unimaginable, but true.

Policy


Aetna does not cover the Cavitat Ultrasonograph, an ultrasonograph bone densitometer that has primarily been used to detect neuralgia inducing cavitational osteonecrosis in the jaw bones. The Cavitat Ultrasonograph is considered experimental and investigational.

Background

The Cavitat Ultrasonograph (Cavitat Medical Technologies, Aurora, CO) provides an ultrasound-based, three-dimensional image of the alveolar processes of the maxilla and mandible. The Cavitat Ultrasonograph was cleared for marketing by the FDA based on a 510(k) application. Thus, the manufacturer was not required to supply the evidence of effectiveness that would be required to support a pre-market approval application (PMA). The FDA-approved labeling states that the clinical significance of the Cavitat ultrasound images is unknown. The indications section of the product labeling contains the following statement:


The clinical significance and correlation of the CAVITAT (Ultrasonograph) images, including column height and color grading, has not been established for specific osseous pathology, or normal bone. Positive images represent alveolar regions that attenuate ultrasound signals.
According to the manufacturer, the Cavitat ultrasonograph detects and precisely images porosity of the bone to aid medical professionals in diagnosing bone marrow edema syndrome, neuralgia inducing cavitational osteonecrosis (NICO), osteomylitis and periodontal pockets of the buccal bone. However, there are no articles on the effectiveness of the Cavitat published in peer-reviewed medical journals. The manufacturer cites a number of abstracts in support of the effectiveness of the Cavitat. However, abstracts do not undergo the detailed peer review that is required for publication of an article in a quality peer-reviewed medical journal. Furthermore, the abstracts provide insufficient description of study methodology to allow one to draw conclusions about the validity of the results. For example, the abstracts fail to provide sufficient detail about how subjects for study were selected, inadequate description of the gold standard, whether the investigators were blinded to results of competing studies, and whether the results of the ultrasonography improved outcomes.

In addition, the clinical significance of "neuralgia inducing cavitational osteonecrosis" (NICO), or cavitational osteopathosis, has been called into question. Dodes and Schissel (2000) reviewed the history of this syndrome. They explained that the American Academy of Biological Dentistry and other proponents of NICO claim that facial pain is caused by infected "cavities" within the jaw bones. In addition, some proponents claim they can cure such conditions as arthritis, heart disease, and pain throughout the body by removing these infected cavities from the patient's jawbones. Unlike abscesses, cysts, or periapical lesions, these cavities are not apparent on x-ray films, but are only detectable with a Cavitat Ultrasonograph.

Proponents claim that these infected cavities are not treatable with Antibiotics , but the infection must be cured by surgically scraping them out. Some practitioners have advocated rinsing the "cavity" with Colloidal Silver and administering chelation therapy and intravenous vitamin C. Some proponents of biological dentistry have claimed that root-canal-treated teeth cause NICO as well as a host of other chronic systemic diseases. These proponents remove all root-canal-treated teeth and most of the vital teeth close to the area where they say an infection exists. As a result, patients have had healthy teeth removed without any improvement in their diseases.

Dodes and Schissel concluded, however, that there is no scientific evidence to support these assertions or the diagnostic and treatment methods based on them. NICO's prime promoter is J.E. Bouquot, D.D.S., M.S.D., a West Virginia oral pathologist who coined the term in the 1980s. Dodes and Schisseld reported that several oral pathologists who blindly reviewed the same tissue blocks that Dr. Bouquot had diagnosed as having NICO judged the tissue to be entirely normal.

In fact, the FDA labeling states that "The clinical significance and correlation of the CAVITAT (Ultrasonograph) images, including column height and color grading, has not been established for specific osseous pathology, or normal bone………”

The above policy is based on the following references:


Bouquot J, Martin W, Wrobleski G. Computer-based thru-transmission sonography (CTS) imaging of ischemic osteonecrosis of the jaws -- a preliminary investigation of 6 cadaver jaws and 15 pain patients [abstract]. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2001;92:550. http://www.cavitatmedtech.homestead.com/Publication1.html (accessed July 8, 2002).
Bouquot JE, Shankland WE II, Margolis M. Through-transmission alveolar ultrasonography (TAU) -- new technology for evaluation of bone density and desiccation. Comparison with radiology of 170 biopsied alveolar sites of osteoporotic and ischemic disease [abstract]. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002;93:in press. http://www.cavitatmedtech.homestead.com/Publication2.html (accessed July 8, 2002).
Bouquot JE, Margolis M, Shankland WE II. Through-transmission alveolar sonography (TTAS) -- a new technology for evaluation of medullary diseases. Correlation with histopathology of 285 scanned alveolar sites [abstract]. Proceedings, annual meeting, American Academy of Oral & Maxillofacial Pathology, New Orleans, April 2002. http://www.cavitatmedtech.homestead.com/Publication3.html (accessed July 8, 2002).
Bouquot JE, Shankland WE II, Margolis M, Glaros W. Through-transmission alveolar ultrasonography (TAU) -- new technology for detection of low bone density of the jaws. Comparison with radiology for 92 osteoporotic alveolar sites with histopathologic confirmation. Proceedings, annual meeting, American Academy of Oral & Maxillofacial Pathology, New Orleans, LA, April 2002. http://www.cavitatmedtech.homestead.com/Publication4.html (accessed July 8, 2002).
Cavitat Medical Technologies, Inc. [Website]: http://www.cavitatmedtech.homestead.com/index.html (accessed July 8, 2002).
Dodes JE, Schissel M. Cavitational osteopathosis, NICO, and 'biological dentistry'. Allentown, PA: Quackwatch; July 14, 2000. http://www.quackwatch.com/
01QuackeryRelatedTopics/cavitation.html (accessed July 8, 2002).
U.S. Food and Drug Administration, Center for Devices and Radiologic Health. Cavitat Ultrasound Bone Densitometer ("Cavitat"). 510(k) No. K011147. Rockville, MD: FDA; February 15, 2002. http://www.fda.gov/cdrh/pdf/k011147.pdf (accessed July 8, 2002).
Shankland WE 2nd. Medullary and odontogenic disease in the painful jaw: Clinicopathologic review of 500 consecutive lesions. Cranio. 2002;20(4):295-303.
US Food and Drug Administration. 510(k)s Final Decisions Rendered for February 2002. http://www.fda.gov/cdrh/510k/sumfeb02.html (accessed February 2003).


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