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OFFICE OF CLINICAL AFFAIRS
BCD Protocol for Patients on Bisphosphonate Therapy

Protocol Committee: Dr. Charles Wakefield, Director, AEGD Residency, Dr. Gil Triplett, Professor/Chair, Oral & Maxillofacial Surgery, Dr. David Grogan, Assistant Professor/Vice Chair, Oral & Maxillofacial Surgery, Dr. Sterling Schow, Professor/Director, Oral & Maxillofacial Surgery, Dr. William Hallmon, Professor/Chair, Periodontics, Dr. David Kerns, Associate Professor/Clinical, Periodontics, Dr. Terry Rees, Director of Stomatology, Periodontics
Background: Bisphosphonates are prescribed for a variety of medical conditions as both preventive and therapeutic medications. They are available in oral and intravenous forms. The action of bisphosphonates is to significantly decrease osteoclastic activity, with the purpose of minimizing osteolytic lesions of bone in patients treated for osteoporosis and bone lesions associated with primary and metastatic cancer. These medications concentrate in bone and remain unaltered metabolically for decades, even after discontinuance. Bone becomes increasingly less vascularized due to lack of resorption of older bone, resulting in diminished capacity to heal with a normal inflammatory process when exposed through trauma and/or infection. This is termed osteonecrosis of the jaws (ONJ) or bisphosphonate-related osteonecrosis of the jaw (BRONJ).
Although bisphosphonates have a systemic effect on bone, related complications have only been documented in the jaws, with approximately 61% of lesions present in the mandible and the remainder in the maxilla. Thus, patients taking these medications must be identified, given thorough informed consent regarding potential complications of dental treatment, and treated appropriately as described in this protocol. A dedicated question will be added to all electronic health form medical histories at BCD listing the medications so they can be clearly identified by the patient. This entry should also provide information on how long the patient has been taking the medication and for what medical condition. Follow-up with medical consultation for clarification, and with oral and maxillofacial surgery is indicated when the treatment plan is in question.
- Are you or have you ever been prescribed any of the following medications?
ORAL:

Actonel® - risedronate

Boniva® - ibandronate

Fosamax® - alendronate

Fosamax Plus D® - alendronate

Skelid® - tiludronate

Didronel® - etidronate
IV:

Aredia® - pamidronate

Zometa® - zoledronate

Reclast® - zoledronate

Bonefos® - clodronate

- How long have you been taking this medication?


- For what medical condition?
- Do you have problems with wound healing?
- Are you currently taking other medications for this condition such as chemotherapy or
steroids?
- Have you had tooth extractions, cleanings and restorations (fillings) since you have
been taking this medication? Any problems with these?

In all cases, the recommendation is for conservative surgical procedures (when needed) involving minimal trauma and primary closure; proper sterile technique always; use of oral disinfectants; and effective antibiotic therapy when appropriate. Physicians must be educated and encouraged to have all patients have a thorough dental examination and completion of major procedures such as extractions, periodontal procedures and osseointegration of implants before initiation of bisphosphonate therapy or as soon as possible after starting. Patients must be educated and subsequently closely monitored to perform the highest degree of oral hygiene. Other risk factors in addition to bisphosphonates must be identified that are associated with ONJ/BRONJ. These include periodontal disease, dental procedures involving violation of the biologic width, and trauma to edentulous areas from poor fitting prosthodontic appliances.


BCD Protocol
1. All current and new patients complete the new electronic health form medical history on initial or update/recall medical histories. Medical consultation is performed for clarification when needed and whenever alteration in bisphosphonate therapy is desired.

2. Patients Taking Oral Bisphosphonates:


Data is only beginning to be published on Fosamax. The remaining oral medications are suspected to show similar results with time. Instructions for Fosamax state all dental treatment is allowed if length of prescribed therapy has not exceeded three years. Co-morbidities raising highest concern in these patients are chronic steroid therapy, cardiovascular disease, diabetes, smoking, COPD, periodontitis, poor oral health and advanced age.

ORAL BISPHOSPHONATES:

I. Patients initiating oral bisphosphonate therapy:
- Complete dental exam, including panoramic radiograph
- Definitive comprehensive treatment to include oral hygiene instruction and
education to maintain excellent oral health. Eliminate dental and periodontal
pathology.
- Allow healing following invasive procedures before therapy begins.
- Regular follow-up care to maintain excellent oral health.
- Changes in bisphosphonate regimens should occur only
after consultation and orders of the patient’s physician.

II. Patients currently taking oral bisphosphonates:


- Complete dental exam. Comprehensive informed consent.
- Medical consultation if multiple risk factors present (steroids, other chemotherapy,
diabetes, over age 65, etc)
- Patient education and follow-up monitoring for excellent oral hygiene
- Patients taking oral bisphosphonates for less than three years: Definitive
comprehensive dental care. Elimination of dental and periodontal
pathology. If invasive procedures required (extractions, deep cleaning involving
biologic width, flap procedures), have patient rinse with 0.12% chlorhexidine 2x
daily for 2 months in addition to other postoperative instructions. If patient has taken
steroids, discontinue oral bisphosphonate for at least three months before invasive
dental treatment and until osseous healing following surgery. Orthodontic treatment
should be non-invasive and minor to minimize periodontal inflammation and stress
to bone.
- Patients taking oral bisphosphonates for more than three years with or without
steroid therapy: discontinue bisphosphonate for three months prior to invasive dental
treatment and do not resume until osseous healing has occurred.
- Regular follow-up care to maintain excellent oral health.

IV BISPHOSPHONATES:

I. Patients initiating IV bisphosphonate therapy:
- Complete dental exam, including panoramic radiographs
- Definitive comprehensive treatment to include oral hygiene instruction and
education to maintain excellent oral health. Complete elimination of dental and
periodontal pathology. This includes crowns on teeth susceptible to fracture,
extraction of nonrestorable or periodontally uncorrectable teeth, and creation of an
oral environment that the patient can efficiently maintain in a high state of health.
- Allow adequate healing time (2 – 3 weeks) before initiation of IV therapy.
- Avoid orthodontic treatment.

II. Patients receiving IV bisphosphonates:


- Complete dental exam. Medical consultation for need of prophylactic antibiotics
prior to probing. This includes patients with indwelling catheters/ports used for
chemotherapy. Have patients rinse with 0.12% chlorhexidine prior to oral exam.
- Examine and adjust all removable prosthodontic appliances to eliminate all areas of
tissue trauma, especially on lingual flanges.
- Thorough oral hygiene instruction Encourage atraumatic technique.
- Provision of routine prophylaxis. Rinse with 0.12% chlorhexidine prior to procedure
and after. If bleeding has occurred (biologic width violated), continue 0.12%
chlorhexidine 2X/day for 2 months. Scaling should be done by sextant or quadrant
with subsequent appointments delayed for two weeks to assure proper healing and
tissue response to procedure. Emphasis must be placed on gentle debridement with
effort to not induce bleeding. Supragingival and noninvasive subgingival
debridement should be performed progressively as inflammation resolves.

- Definitive restorative care with local anesthesia. Rinse with 0.12% chlorhexidine


before all procedures. Avoidance of biologic width trauma with matrix bands,
placement of retraction cord, etc.
- Avoidance of invasive procedures such as extractions, placement of implants and
other elective surgery. Endodontic therapy is preferred, avoiding tissue trauma past
the apex. If necessary, decoronation of the tooth and placement of a restoration on
roots to seal root canals will be the definitive treatment.

- Frequent follow-ups to include exams, cleaning, reinforcement of oral hygiene and


management of xerostomia.

III. Patients with ONJ/BRONJ:


- In general, same protocol as for patients taking IV bisphosphonates, but with
meticulous care and technique
- Complete dental exam, including panoramic radiograph
- Emphasize and educate patients as to the need for meticulous atraumatic oral
hygiene.
- Document signs and symptoms of possible ONJ to include pain, swelling, infection
of gums, drainage, loosening of teeth, poor healing of gums, numbness or feeling of
heaviness in jaw; sharp, hard areas protruding from tissue; bad taste/breath.
- Rule out metastatic bone lesions vs ONJ. Bone scan to map lesions outside jaws.
This procedure would normally be done in concert with oral surgery.
- Removal or aggressive relief of removable prosthesis over affected areas.
- Identify ONJ sites or development potential and consult oral surgery. For immediate
relief, conservative smoothing of sharp/rough areas to relieve trauma. Prescribe
0.12% chorhexidine 2x/day for 2 months and antibiotics if appropriate.
- Antibiotics prn including amoxicillin, metronidazole, tetracycline or clindamycin.

- Conservative regular professional prophylaxis with minimal trauma to biologic


width. Postoperative regimen of chlorhexidine and antibiotics as before.

References:


1. “Taking Care of Yourself While Living With Cancer – Dental Health and
Osteonecrosis of the Jaw”, Novartis pamphlet ONC-8155(03), 2005

2. “ Important Drug Precaution for Dental Health Professionals With Patients Being


Treated For Cancer” , Novartis Oncology, May 5, 2005

3. Novartis letter to doctors, July 19, 2006

4. “Osteonecrosis of the Jaw”, American Dental Association Website, July 12, 2006

5. “Practical Guidelines for the Prevention, Diagnosis, and Treatment of Osteonecrosis


of the Jaw in Patients With Cancer”, Ruggiero, S., et al; Jnl of Oncology Practice,
Vol 2, Issue 1, p. 7 – 14, January 2006

6. “Expert Panel Recommendations: Dental Management of Patients on Oral


Bisphosphonate Therapy”, Report of the Council on Scientific Affairs, ADA, June
2006

7. “Systematic Review: Bisphosphonates and Osteonecrosis of the Jaws”, Woo, S.,


Hellstein, J.W., and Kalmar, J.R.; Annals of Internal Medicine, Vol 144, No 10,
p. 753 – 762, May 2006

8. “Endodontic Implications of Bisphosphonate-Associated Osteonecrosis of the Jaws”,


American Association of Endodontists Position Statement, 2006

9. Baylor College of Dentistry Management of Patients Receiving Intravenous


Bisphosphonate Therapy (Department of Periodontics – February 23, 2006)

10. “Bisphosphonate Induced Osteochemonecrosis of the Jaws: An Ounce of Prevention


May be Worth a Pound of Cure”, Hellstein, J.W., and Marek, C.L.; Special Care
Dent, Vol 26, No 1, p. 8 – 12, January-February 2006

11. “Managing the care of patients with bisphosphonate-associated osteonecrosis – An


American Academy of Oral Medicine position paper”, Migliorati, C.A., et al, JADA,
Vol 136, No 12, p. 1658 – 1668, December 2005

12. “Osteonecrosis of the jaws in patients with a history of receiving bisphosphonate


therapy – Strategies for prevention and early recognition”, Melo, M.D., and Obeid,
G.; JADA, Vol 136, No 12, p. 1675 – 1681, December 2005”

13. “Bisphosphonates, hypercalcemia of malignancy, and osteonecrosis of the jaw”,


Wynn, R.L., General Dentistry, Vol 53, No 6, p. 392 – 395, November-December
2005

14. “Dental management of patients receiving oral bisphosphonate therapy – Expert


panel recommendations”, ADA Council on Scientific Affairs, JADA, Vol 137,
No 8, August 2006, p. 1144 – 1150

15. “American Association of Oral and Maxillofacial Surgeons Position Paper on


Bisphosphonate-Related Osteonecrosis of the Jaws”, September 25, 2006
16. “Oral & Intravenous Bisphosphonate-Induced Osteonecrosis of the Jaws – History,
Etiology, Prevention and Treatment”; Marx, RE, Quintessence Publishing, 2007

17. “Bisphosphonate Treatment: A present orthodontic concern calling for a proactive



approach”, Zabrowski, J., J of Amer Assoc of Orthodontics, p. 4 – 9, Jul/Aug 2006




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