Peninsula Dental Social Enterprise (PDSE)

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1 Peninsula Dental Social Enterprise (PDSE) Surgical Management of Patients on Bisphosphonates Version 2.0 Date approved: December 2014 Approved by: The Board Review due: December 2015 Page 1 of 10

2 Clinical Guidelines for Patients on Bisphosphonates General Evidence has shown that patients taking bisphosphonate drugs are at risk of developing osteonecrosis of the jaws (BONJ), sometimes occurring spontaneously, but more usually following dental extractions or oral bone surgery. Bisphosphonates are prescribed to patients who have problems with bone or calcium metabolism. These include: o Osteoporosis o Osteopenia o Pagets disease o Osteogenesis imperfecta o Hypercalcaemia of malignancy o Bone metastases o Lytic lesions of multiple myeloma Bisphosphonates: Routes of Administration Oral o Risedronate (Actonel) o Ibandronate (Boniva) o Etidronate (Didronel) o Alendronate (Fosamax) o Tiludronate (Skelid) Intravenous o Pamidronate (Aredia) o Clodronate (Bonefos) o Zolendronate (Zometa) BONJ: Case Definition Patients may be considered to have BRONJ if all of the following three characteristics are present: 1. Current or previous treatment with a bisphosphonate; 2. Exposed bone in the maxillofacial region persisting for more than 8 weeks; and 3. No history of radiation therapy to the jaws. Page 2 of 10

3 Risk Groups Contrary to earlier reports, the risk of BONJ is not exclusively related to the route of administration (oral / intravenous). Drug-related factors, (dose, duration, route of administration, frequency & potency) will influence the risk of BONJ. Evidence shows that the high dose, high potency bisphosphonates used in the treatment of malignancy are associated with a greater risk and severity of BONJ. However, high potency bisphosphonates at lower doses are licensed for treatment of osteoporosis (zoledronic acid, and ibandronate). Probably tailored doses (5 mg/ year and 3 mg/3 months respectively) of intravenous regimens will have similar reduced risks and severity of BONJ as the lower potency oral preparations used to treat osteoporosis. However, high dose, high potency bisphosphonates can also be given orally in the management of oncology patients (Bondronat, Roche, 50 mg/day), and these regimes should not be confused with the more common lower doses of the same drug prescribed orally in osteoporosis. Low Risk Group Patients who are receiving bisphosphonate therapy for the treatment of osteoporosis and Paget s disease are categorised in the low risk group for BONJ (NB: Paget s disease is usually treated with only a short course of bisphosphonates). High Risk Group Regardless of the route of bisphosphonate administration (intravenous or oral), oncology patients who have received these drugs are considered in the high risk category for BONJ. Patients who have previously been diagnosed with BONJ should also be placed in a high risk category. Intermediate Risk Group Patients who are receiving intermediate doses of bisphosphonates (usually up to three times the dose for osteoporosis) for non-metastatic cancer may be categorised in the intermediate risk group for BONJ. Additional Risk factors for BONJ include: Local Risk Factors All dentoalveolar surgery Mandibular molar extractions Periodontitis / poor oral hygiene Trauma related to dentures Thin mucosal coverage, lingual to lower molars and bony tori. General Risk Factors Concomitant therapies: corticosteroids Smoking Other immunosuppressants (e.g. methotrexate, thalidomide) Chemotherapeutic agents (e.g. hormone antagonists) Systemic conditions affecting bone turnover: immunocompromised patients, rheumatoid arthritis, poorly controlled diabetes Page 3 of 10

4 Avoiding / delaying extractions Endodontics should be considered as an option before an extraction. In symptomatic endodontically treated teeth, endodontic retreatment should be considered. Non-restorable teeth can be considered for coronectomy and kept in the dental arch as endodontically treated retained roots. Avoidance or delaying an extraction could in some cases be considered as a risk reduction strategy. However, the unnecessary delay or avoidance of appropriate treatment cannot be supported and each case should be considered on its own merits. Informed consent / What are the risks? Current estimates on prevalence and incidence of BONJ are based on anecdotal reports, case series, voluntary surveillance systems and safety reports to pharmaceutical companies. There is a risk of spontaneous BONJ occurring in any patient on bisphosphonates. The frequency of spontaneous BONJ in low-risk group has been reported to be low (0.01% to 0.04%). This frequency may increase following extractions (0.09% to 0.34%), but fortunately severe destructive BONJ has only rarely been reported in the low risk group. The frequency of spontaneous BONJ in high risk group has been reported to be higher (0.88% to 1.15%). This frequency may increase further following extractions (6.67% to 9.1%) and these would be more likely to be examples of progressive, severe and destructive BONJ. Root fracture during extraction In the low risk case, progression to a conventional surgical procedure should be considered. Minimizing the unnecessary exposure of bone by keeping periosteal flaps small should be attempted where practical. If a decision is made to prescribe antibiotics, the most effective administration would be to deliver preoperatively. Primary closure is not considered imperative, especially if this is dependent on the further lifting of the periosteum. In case of doubt, the patient may be referred to Dr. K Ali for further management. Adjunctive Therapy: Surgical Antibiotic Prophylaxis (SAP) Antibiotic prophylaxis not indicated in the low risk group. In contrast prophylactic antibiotics are recommended in the high risk group. Penicillin V (phenoxymethylpenicillin), prescribed preoperatively, is recommended. Alternatives include doxycycline, metronidazole, amoxycillin or clindamycin. Page 4 of 10

5 Simplified Protocol for extractions on LOW RISK Group Establish that all non-extraction options have been considered Assess whether the patient has any local or general risk factors for the development of BONJ and reduce as many as possible prior to extraction. (Apart from old age, all other risk factors can potentially be reduced.) Obtain INFORMED CONSENT. The patient must be made aware of the of developing BONJ. quantitative risk Pre-extraction The patient must have satisfactory oral hygiene The patient should rinse the mouth with % chlorhexidine gluconate (Corsodyl) mouthwash: o Three times on the day before the extraction o The morning of the extraction Remember to advise the patient to do this at least 30 minutes after cleaning the teeth with toothpaste as the sodium lauryl sulphate in the toothpaste will prevent the chlorhexidine from working Extraction The removal of a tooth should be performed with the least traumatic extraction technique and preferably one tooth at a time or a sextant by- sextant approach. If obvious sharp socket wall margins or inter-radicular bone are observed following the procedure, these should be reduced selectively without lifting the periosteum from the bone. Post-extraction The patient should rinse twice daily with chlorhexidine mouthwash for the first week and thereafter daily, until the socket has healed. The patient should be reviewed at appropriate intervals until the socket has healed completely If the socket does not heal, or there are signs and symptoms of BONJ, (3-4 weeks) the patient should be referred to Dr. K Ali as an urgent referral. If an urgent appointment is unavailable, the patient should be referred to the appropriate oral and maxillofacial surgery department (Derriford / Truro / Exeter). Page 5 of 10

6 Simplified Protocol for extractions on HIGH RISK Group Establish that all non-extraction options have been considered Assess whether the patient has any local or general risk factors for the development of BONJ and reduce as many as possible prior to extraction Obtain INFORMED CONSENT. The patient must be made aware of the quantitative risk of developing BONJ. Liaise with the patient s General Medical Practitioner (GMP) and discuss the scope for a drug holiday. Recommendations indicate that patients who are high risk may benefit from the drugs being stopped for three months prior to, and after, the extraction. If a drug holiday is agreed, proceed with the extraction (as with low-risk) after an appropriate interval and monitor as per low risk after the extraction(s). If a drug holiday is not possible, refer the patient to the appropriate oral and maxillofacial surgery department (Derriford / Truro) Page 6 of 10

7 Algorithm: Extractions in Bisphosphonate Patients (Please read explanatory notes) Page 7 of 10

8 BONJ Staging and Treatment BONJ Staging At risk category No apparent necrotic bone in patients who have been treated with either oral or IV bisphosphonates Treatment Strategies No treatment indicated Patient education Stage 0 No clinical evidence of necrotic bone, but non-specific clinical findings and symptoms Systemic management, including the use of pain medication and antibiotics Stage 1 Exposed and necrotic bone in patients who are asymptomatic and have no evidence of infection Antibacterial mouth rinse Clinical follow-up on a quarterly basis Patient education and review of indications for continued bisphosphonate therapy Stage 2 Exposed and necrotic bone associated with infection as evidenced by pain and erythema in the region of the exposed bone with or without purulent drainage Symptomatic treatment with oral antibiotics Oral antibacterial mouth rinse Pain control Superficial debridement to relieve soft tissue irritation Stage 3 Exposed and necrotic bone in patients with pain, infection, and one or more of the following: exposed and necrotic bone extending beyond the region of alveolar bone,(i.e., inferior border and ramus in the mandible, maxillary sinus and zygoma in the maxilla) resulting in pathologic fracture, extraoral fistula, oral antral/oral nasal communication, or osteolysis extending to the inferior border of the mandible of sinus floor Antibacterial mouth rinse Antibiotic therapy and pain control Surgical debridement/resection for longer term palliation of infection and pain Page 8 of 10

9 General Recommendations for Dental Care of Patients on Bisphosphonates Low Risk Group Dental regime Regular dental visits; Oral health maintenance Dental Screening No additional dental examination required Extractions See above protocol Periodontal disease Perio surgery is appropriate. Dentures Must be well-fitting Endodontics Implants Conventional orthograde endodontics preferable to extractions; avoid apical surgery Not contra-indicated but informed consent mandatory (risk assessment) Dental regime Dental Screening High Risk Group Regular dental visits (As appropriate) Oral health maintenance essential Yes before starting high potency /dose therapy Invasive procedures, if needed, should be carried out and healing completed before starting bisphosphonates Liaise with physicians / oncologists Extractions See above protocol Periodontal disease Dentures Endodontics Implants Perio surgery is not recommended Non-surgical perio treatment only Good fitting dentures possibly with soft lining to prevent trauma Conventional orthograde endodontics preferable to extraction Avoid apical surgery Not recommended and avoid elective dento-alveolar surgery Page 9 of 10

10 Additional Drugs: Denosumab (XGEVA, Amgen, Prolia) is recommended by NICE as a treatment for people with bone metastases from most solid cancer tumours. Also postmenopausal women at risk of fractures can now be treated with this drug on the NHS o o o o o Denosumab is a human monoclonal antibody administered subcutaneously. It is a member of the TNF cytokine family and functions to inhibit osteoclast differentiation and activation. Denosumab has been identified as just as high a risk factor for osteonecrosis of jaws as bisphosphonates. Denosumab also suppresses the immune system increasing the risk of opportunistic infections. Patients on densumab require meticulous preventive dental care to reduce the risk of irreversible dental disease. If a patient on denosumab requires invasive surgical treatment on clinic including extractions, they may be referred to local oral surgery clinic for further management. References 1. National study on avascular necrosis of the jaws including bisphosphonate-related necrosis FGDP 2. N. Malden, C. Beltes and V. Lopes. Dental extractions and bisphosphonates: the assessment, consent and management, a proposed algorithm. BDJ 2009: 206: American Association of Oral and Maxillofacial Surgeons Position Paper on Bisphosphonate-Related Osteonecrosis of the Jaw 2009 Update Page 10 of 10