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Clinical Policy Bulletin:
Neuralgia Inducing Cavitational Osteonecrosis (NICO) and Ultrasonograph Bone Densitometer to Detect NICO
Number: 0642


Policy

  1. Aetna considers surgery (including scraping of “infected cavities” and removal of root-canal-treated teeth) and/or any other therapies (e.g., rinsing the "cavity" with colloidal silver and administering chelation therapy and intravenous vitamin C) and bone graft replacement for the treatment of neuralgia inducing cavitational osteonecrosis (NICO)-related diagnoses to be experimental and investigational because the clinical significance of this syndrome is in question.

  2. Aetna considers the use of devices to image the jawbones to diagnose NICO or NICO-type conditions experimental and investigational because there is no adequate scientific evidence to support their clinical value.



Background

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 jawbones.  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 purportedly detectable with an ultrasonograph bone densitometer. 

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 (2000) concluded, however, that there is no scientific evidence to support these assertions or the diagnostic and treatment methods based on them.  The prime promoter of NICO is J.E. Bouquot, D.D.S., M.S.D., a West Virginia oral pathologist who coined the term in the 1980s.  Dodes and Schissel 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.

The Food and Drug Administration-cleared labeling on one device used to assist in diagnosing NICO or NICO-type conditions states that the clinical significance of the images is unknown.  The indications section of the product labeling contains the following statement: "The clinical significance and correlation of the [device’s] 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."

An ultrasonograph bone densitometer purportedly detects and precisely images porosity of the bone to aid medical professionals in diagnosing bone marrow edema syndrome, NICO, osteomyelitis and periodontal pockets of the buccal bone.  However, there are no articles on the effectiveness of the device published in peer-reviewed medical journals.  The manufacturer cites a number of abstracts in support of the effectiveness of the device.  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 a series of articles reviewing unconventional dental practices and products published in the Journal of the Canadian Dental Association, Goldstein and Epstein (2000) stated that “papers supporting 'scientific' aspects of NICO have been published in peer-reviewed mainstream journals.  The publications offer changing explanations with only anecdotal case reports and no definitive etiology, biochemistry, histopathology, neuropathology or diagnosable clinical features meeting scientific standards of proof, while advocating repeated surgical procedures for diagnosis and therapy, also without proof of effectiveness.  At present, the existence of NICO as a clinical entity remains unproven and unaccepted by the majority of science-based practitioners.  NICO must be evaluated by well-designed studies; until then, unproven concepts should not be the basis for invasive dental surgical procedures".

Sciubba (2009) stated that NICO remains controversial several years following the initial description.  Changing etiologic concepts have led to confusion as well as the significant departures from the concept first defined by Ratner, which served as the basis for the explaining the pain syndrome with features of trigeminal neuralgia.  Since the earliest publications on the subject by Bouquot et al, there have been many challenges and counter-claims to the concept introduced.  The author noted that absence of any form of research design and approval by institutional review panels remains a weakness in terms of acceptance of the information provided in the literature said to support the stated etiology of this entity.

Glueck et al (2010) hypothesized that, similar to idiopathic hip osteonecrosis, the T-786C mutation of the endothelial nitric oxide synthase (eNOS) gene affecting nitric oxide (NO) production was associated with NICO.  In 22 NICO patients, not having taken bisphosphonates, mutations affecting NO production (eNOS T-786C, stromelysin 5A6A) were measured by polymerase chain reaction; and 2 healthy normal control subjects were matched per case by race and gender.  Homozygosity for the mutant eNOS allele was present in 6 out of 22 patients (27 %) with NICO compared with 0 out of 44 (0 %) race- and gender-matched control subjects; heterozygosity was present in 8 patients (36 %) versus 15 control subjects (34 %); and the wild-type normal genotype was present in 9 patients (36 %) versus 29 controls (66 %) (p = 0.0008). The mutant eNOS T-786C allele was more common in cases (20 out of 44 [45 %]) than in control subjects (15 out of 88 [17 %]) (p = 0.0005).  The distribution of the stromelysin 5A6A genotype in cases did not differ from control subjects (p = 0.13).  The authors concluded that the eNOS T-786C polymorphism affecting NO production is associated with NICO, may contribute to the pathogenesis of NICO, and may open therapeutic approaches to treatment of NICO through provision of L-arginine, the amino-acid precursor of NO.

Klassner and Epstein (2011) reviewed the literature for NICO, and stated that "the etiology, pathogenesis and treatment of NICO are speculative and not well defined, and the reported bone changes may represent variations of normal changes. As a result, one can argue that the symptoms of chronic pain attributed to NICO are better explained by established concepts of neuropathic pain; thus, they should be approached medically and not managed surgically." The authors concluded: "Without a confirmed clinical diagnosis of localized bone pathosis, aggressive and invasive procedures are not warranted. Such interventions may have no effect or may even worsen the pain by increasing sensitization of the central nervous system."

In a position statement, the American Association of Endodontists (AAE, 2012) has stated that the association "cannot condone surgical interventions intended to treat suspected NICO lesions.. . . In addition, the practice of recommending the extraction of endodontically treated teeth for the prevention of NICO, or any other disease, is unethical and should be reported immediately to the appropriate state board of dentistry."

 
CPT Codes / HCPCS Codes / ICD-9 Codes
There is no specific CPT code for the ultrasonograph bone densitometer used to assist in diagnosing NICO or NICO-type conditions.:
CPT codes not covered for indications listed in the CPB:
21025
21026
21030
21040
21046
21048
Other CPT codes related to the CPB:
76977
HCPCS codes not covered for indications listed in the CPB:
D3310 - D3353 Root canal therapy
D7410 - D7412 Excision of benign lesions
D7450 - D7461 Removal of benign odontogenic cyst or tumor
S9355 Home infusion therapy, chelation therapy; administrative services, professional pharmacy services, care coordination, and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem
ICD-9 codes not covered for indications listed in the CPB:
350.1 - 350.9 Trigeminal nerve disorders
352.1 Glossopharyngeal neuralgia
522.5 Periapical abscess without sinus
522.6 Chronic apical periodontitis
522.7 Periapical abscess with sinus
526.4 Inflammatory conditions of jaw
730.18 Chronic osteomyelitis, other specified site
733.45 Aseptic necrosis of jaw


The above policy is based on the following references:
  1. 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. Available at: http://www.cavitatmedtech.homestead.com/Publication1.html. Accessed July 8, 2002.
  2. 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. Available at: http://www.cavitatmedtech.homestead.com/Publication2.html. Accessed July 8, 2002.
  3. 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. Available at: http://www.cavitatmedtech.homestead.com/Publication3.html. Accessed July 8, 2002.
  4. 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. Available at: http://www.cavitatmedtech.homestead.com/Publication4.html. Accessed July 8, 2002.
  5. Cavitat Medical Technologies, Inc. [Website]: Available at: http://www.cavitatmedtech.homestead.com/index.html. Accessed July 8, 2002.
  6. Dodes JE, Schissel M. Cavitational osteopathosis, NICO, and 'biological dentistry'. Allentown, PA: Quackwatch; July 14, 2000. Available at: http://www.quackwatch.com/01QuackeryRelatedTopics/cavitation.html. Accessed July 8, 2002.
  7. 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. Available at: http://www.fda.gov/cdrh/pdf/k011147.pdf. Accessed July 8, 2002.
  8. Shankland WE 2nd. Medullary and odontogenic disease in the painful jaw: Clinicopathologic review of 500 consecutive lesions. Cranio. 2002;20(4):295-303.
  9. U.S. Food and Drug Administration (FDA). 510(k)s Final Decisions Rendered for February 2002. Rockville, MD: FDA; 2002. Available at: http://www.fda.gov/cdrh/510k/sumfeb02.html. Accessed February 2003.
  10. Zuniga JR. Challenging the neuralgia-inducing cavitational osteonecrosis concept.  J Oral Maxillofac Surg. 2000;58(9):1021-1028.
  11. Bouquot JE, McMahon RE. Neuropathic pain in maxillofacial osteonecrosis. J Oral Maxillofac Surg. 2000;58(9):1003-1020.
  12. Ratner EJ, Langer B, Evins ML. Alveolar cavitational osteopathosis. Manifestations of an infectious process and its implication in the causation of chronic pain. J Periodontol, 1986;57(10):593-603.
  13. Bouquot JE, Roberts AM, Person P, Christian J. Neuralgia-inducing cavitational osteonecrosis (NICO). Osteomyelitis in 224 jawbone samples from patients with facial neuralgia. Oral Surg Oral Med Oral Pathol. 1992,73(3):307-319; discussion 319-320.
  14. Bouquot JE, Christian J. Long-term effects of jawbone curettage on the pain of facial neuralgia. J Oral Maxillofac Surg. 1995;53(4):387-397; discussion 397-399.
  15. Glueck, CJ, McMahon RE, Bouquot J, et al. Thrombophilia, hypofibrinolysis, and alveolar ostonecrosis of the jaws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 1996;81(5):557-566.
  16. Glueck CJ, McMahon RE, Bouquot JE, et al. A preliminary pilot study of treatment of thrombophilia and hypofibrinolysis and amelioration of the pain of osteonecrosis of the jaws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998;85(1):64-73.
  17. Goldstein BH. Unconventional dentistry: Part III. Legal and regulatory issues. J Can Dent Assoc. 2000;66(10):503-506. Available at: http://www.cda-adc.ca/jcda/vol-66/issue-9/index.html. Accessed May 25, 2004.
  18. Goldstein BH, Epstein JB. Unconventional dentistry: Part IV. Unconventional dental practices and products. J Can Dent Assoc. 2000;66(10):564-568. Available at: http://www.cda-adc.ca/jcda/vol-66/issue-10/index.html. Accessed May 25, 2004.
  19. Follmar KE. Taking a stand against fraud and quackery in dentistry. J Am Coll
    Dent. 2003;70(3):4-5.
  20.  
  21. Bagheri SC, Farhidvash F, Perciaccante VJ. Diagnosis and treatment of patients with trigeminal neuralgia. J Am Dental Assoc. 2004;135;1713-1717.
  22. American Cancer Society (ACS). Biologic dentistry. Making Treatment Decisions. Atlanta, GA: ACS; revised May 23, 2007. Available at: http://www.cancer.org/docroot/ETO/content/ETO_5_3X_Biological_Dentistry.asp. Accessed September 18, 2008.
  23. Sciubba JJ. Neuralgia-inducing cavitational osteonecrosis: A status report. Oral Dis. 2009;15(5):309-312.
  24. Glueck CJ, McMahon RE, Bouquot JE, et al. T-786C polymorphism of the endothelial nitric oxide synthase gene and neuralgia-inducing cavitational osteonecrosis of the jaws. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010;109(4):548-553.
  25. Lechner J, Mayer W. MayerbImmune messengers in Neuralgia Inducing Cavitational Osteonecrosis (NICO) in jaw bone and systemic interference. Eur J Integrative Med. 2010;2:71-77.
  26. Klasser GD, Epstein JB. Neuralgia-inducing cavitational osteonecrosis: A possible diagnosis for an orofacial pain complaint? J Am Dent Assoc. 2011;142(6):651-653.
  27. Bouquot JE, Spolnik K, Adams W, Deardorf K. Technetium-99mTc MDP imaging of 293 quadrants of idiopathic facial pain: 79% show increased radioisotope uptake. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012;114:83-92. 
  28. Grossmann E, Cousen T, Grossmann TK, Bérzin F. Neuralgia inducing cavitational osteonecrosis. Revista Dor. 2012;13(2).
  29. American Association of Endodontists (AAE), Research and Scientific Affairs Committee. NICO Lesions. Neuralgia-Inducing Cavitational Osteonecrosis. AAE Position Statement. Chicago, IL: AAE; 2012.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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