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Limited evidence suggests that low-dose oral bisphosphonate therapy does not increase osteonecrosis risk from implant procedures or adversely affect implant Critical Summary Prepared by: Arthur Jeske DMD, PhD; James Zahrowski DMD, MS, PharmD 

OVERVIEW

  • Systematic Review Conclusion:

    Evaluation of one prospective and 3 retrospective studies suggests that oral bisphosphonate (OBP) therapy for five years or less duration does not affect implant survival rates or increase the risk of bisphosphonate osteonecrosis of the jaws (BRONJ) in patients with osteoporosis.

  • Critical Summary Assessment:

    Limited evidence suggests that osteoporosis treatment of less than five years of duration with low-dose OBP does not adversely affect short-term dental implant outcome or increase risk of BRONJ from implant procedure.

  • Evidence Quality Rating:

    Limited

A Critical Summary of:

What impact do systemically administrated bisphosphonates have on oral implant therapy? A systematic review

Madrid C, Sanz M. Clinical Oral Implants Research. 2009;20 Suppl 4():87-95

  • Clinical Questions:

    In adults receiving high-dose IV BP therapy for cancer or low- dose OBP therapy for osteoporosis, does dental implant placement increase the risk of BRONJ or adversely affect implant survival?

  • Review Methods:

    The authors searched three electronic data bases for articles published up to December 2008. One search yielded four articles related to OBP treatment. A second search yielded a total of six articles, recommendations and guidelines related to IV BP therapy. The authors conducted manual searches to access references in all identified publications. Case reports and small case series were excluded. Because of the scarcity of literature, the authors did not establish specific criteria based on study design. They did not perform a meta-analysis and presented the data in a descriptive manner.

  • Main Results:

    For implant patients receiving low-dose OBP treatment for osteoporosis, the authors evaluated implant survival and risk of BRONJ from one controlled prospective and three retrospective studies (two case-controlled and one case series) totaling 217 patients with 840 implants. The duration of treatment ranged from one to four years prior to implant procedures. All studies followed patients for one to four years after implant placement. Implant survival rates ranged between 95 and 100 percent. None of the patients developed BRONJ and implant outcome was not adversely affected. The authors found no clinical trials in implant patients receiving high-dose IV BP treatment for cancer; however, they evaluated a total of six articles comprising expert opinion and guidelines. Most guidelines recommend that dental implant placement be contraindicated after high-dose IV BP administration.

  • Conclusion:

    In patients receiving low-dose OBP, less than 5 years for osteoporosis treatment, the placement of an implant may be considered a relatively safe procedure. No BRONJ was reported and implant survival rates were not adversely affected 1-4 years after placement. In patients receiving high-dose IV BP treatment for cancers, there was a consensus of expert opinion that dental implants are contraindicated.

  • Source of funding:

    None stated

Commentary:

  • Importance and Context:

    Bisphosphonate (BP) is an effective and oft-used drug in the treatment of diseases affecting bone metabolism, such as bone cancers or osteoporosis. A potent osteoclast inhibitor, BP is preferentially deposited into actively resorbing bone, decreases bone remodeling, and remains integrated in bone for many years, perhaps decades. Since 2002 BRONJ and implant failure have been reported in patients who received high-dose IV BP treatment for cancer. Reports of BRONJ and dental implant failure in patients receiving low-dose OBP treatment for osteoporosis, have now raised concern amongst practitioners.

  • Strengths and Weaknesses of the Systematic Review:

    This systematic review included a comprehensive search with a defined inclusion and exclusion criteria. Bias was introduced by only searching for articles in English. The authors did not search the grey literature and did not contact pharmaceutical manufacturers. One author declared being on a pharmaceutical expert board for BRONJ. The authors did not establish inclusion criteria for study design. Homogeneity tests or meta-analysis could not be performed of the four clinical studies of low-dose OBP therapy.

  • Strengths and Weaknesses of the Evidence:

    All clinical studies evaluated implant outcome during low-dose OBP therapy for osteoporosis. One single-blinded, controlled, nonrandomized prospective study (25 patients) and three retrospective studies (192 patients) were included. Large epidemiological studies are needed to evaluate the incidence of uncommon adverse implant outcomes and increased BRONJ risk during OBP use that cannot be evaluated in studies with small patient numbers. Because no clinical studies evaluated BRONJ or implant outcome for high-dose IV BP, further research should evaluate the possibility of increased risk associated with this treatment modality.

  • Implications for Dental Practice:

    After the publication of this review, a South Australian survey suggested a small additional risk of implant failure with low-dose OBP (0.9%) compared to control (.04%) and a retrospective chart review suggested OBP implant failure rate (14%) compared with control (4%).(1,2) Although dental implant procedures appear to be relatively safe during OBP therapy of less than 5 years, the possibility of a small increased risk of implant failure is in question. The controversy of BRONJ prevalence during OBP continues as recent retrospective studies have reported a higher prevalence of BRONJ associated with low-dose OBP, 1: 1000 (0.1 percent) and up to 1:20 (five percent) after extractions.(3,4) Larger studies with stronger evidence are needed to evaluate the duration of OBP and IV BP effect on dental implant outcome and BRONJ prevalence. Clinicians should continually reevaluate potential risks and benefits associated with extractions and implant placement during OBP therapy and inform patients in a manner to discourage stopping medications which have medical benefit. 1.Goss A, Bartold M, Sambrook P, and Hawker P. The Nature and Frequency of Bisphosphonate-Associated Osteonecrosis of the Jaws in Dental Implant Patients: A South Australian Case Series. J Oral Maxillofac Surg 2010; 68:337-343. 2. Kasai T, Pogrel MA, Hossaini M. The Prognosis for Dental Implants Placed in Patients Taking Oral Bisphosphonates. CDA Journal. 2009; 37(1):39-42. 3.Lo JC, O'Ryan FS, Gordon NP, Yang J, Hui RL ,Martin D, Hutchinson M, Lathon PV, Sanchez G, Silver P, Chandra M, McCloskey CA, Staffa JA, Willy M, Selby JV, Go A. Prevalence of Osteonecrosis of the Jaw in Patients with Oral Bisphosphonate Exposure. J Oral Maxillofac Surg 2010; 68:243-253. 4.Sedghizadeh PP, Stanley K, Caligiuri M, Hofkes S, Lowry B, Shuler CF. Oral bisphosphonate use and the prevalence of osteonecrosis of the jaw. JADA 2009;140:61-6.

  • Critical Summary Publication Date: 6/22/2010

These summaries are not intended to, and do not, express, imply, or summarize standards of care, but rather provide a concise reference for dentists to aid in understanding and applying evidence from the referenced systematic review in making clinically sound decisions as guided by their clinical judgment and by patient needs. American Dental Association ©

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