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. 2022 Jul 12;7(7):CD012432.
doi: 10.1002/14651858.CD012432.pub3.

Interventions for managing medication-related osteonecrosis of the jaw

Natalie H Beth-Tasdogan  1 , Benjamin Mayer  2 , Heba Hussein  3 , Oliver Zolk  4 , Jens-Uwe Peter  4
Affiliations

Interventions for managing medication-related osteonecrosis of the jaw

Natalie H Beth-Tasdogan et al. Cochrane Database Syst Rev. .

Abstract

Background: Medication-related osteonecrosis of the jaw (MRONJ) is a severe adverse reaction experienced by some individuals to certain medicines commonly used in the treatment of cancer and osteoporosis (e.g. bisphosphonates, denosumab, and antiangiogenic agents), and involves the progressive destruction of bone in the mandible or maxilla. Depending on the drug, its dosage, and the duration of exposure, this adverse drug reaction may occur rarely (e.g. following the oral administration of bisphosphonate or denosumab treatments for osteoporosis, or antiangiogenic agent-targeted cancer treatment), or commonly (e.g. following intravenous bisphosphonate for cancer treatment). MRONJ is associated with significant morbidity, adversely affects quality of life (QoL), and is challenging to treat. This is an update of our review first published in 2017.

Objectives: To assess the effects of interventions versus no treatment, placebo, or an active control for the prophylaxis of MRONJ in people exposed to antiresorptive or antiangiogenic drugs. To assess the effects of non-surgical or surgical interventions (either singly or in combination) versus no treatment, placebo, or an active control for the treatment of people with manifest MRONJ.

Search methods: Cochrane Oral Health's Information Specialist searched four bibliographic databases up to 16 June 2021 and used additional search methods to identify published, unpublished, and ongoing studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing one modality of intervention with another for the prevention or treatment of MRONJ. For 'prophylaxis of MRONJ', the primary outcome of interest was the incidence of MRONJ; secondary outcomes were QoL, time-to-event, and rate of complications and side effects of the intervention. For 'treatment of established MRONJ', the primary outcome of interest was healing of MRONJ; secondary outcomes were QoL, recurrence, and rate of complications and side effects of the intervention.

Data collection and analysis: Two review authors independently screened the search results, extracted the data, and assessed the risk of bias in the included studies. For dichotomous outcomes, we reported the risk ratio (RR) (or rate ratio) and 95% confidence intervals (CIs).

Main results: We included 13 RCTs (1668 participants) in this updated review, of which eight were new additions. The studies were clinically diverse and examined very different interventions, so meta-analyses could not be performed. We have low or very low certainty about available evidence on interventions for the prophylaxis or treatment of MRONJ. Prophylaxis of MRONJ Five RCTs examined different interventions to prevent the occurrence of MRONJ. One RCT compared standard care with regular dental examinations at three-month intervals and preventive treatments (including antibiotics before dental extractions and the use of techniques for wound closure that avoid exposure and contamination of bone) in men with metastatic prostate cancer treated with zoledronic acid. The intervention seemed to lower the risk of MRONJ (RR 0.10, 95% CI 0.02 to 0.39, 253 participants). Secondary outcomes were not evaluated. Dentoalveolar surgery is considered a common predisposing event for developing MRONJ and five RCTs tested various preventive measures to reduce the risk of postoperative MRONJ. The studies evaluated plasma rich in growth factors inserted into the postextraction alveolus in addition to standardised medical and surgical care versus standardised medical and surgical care alone (RR 0.08, 95% CI 0.00 to 1.51, 176 participants); delicate surgery and closure by primary intention versus non-traumatic tooth avulsion and closure by secondary intention (no case of postoperative MRONJ in either group); primary closure of the extraction socket with a mucoperiosteal flap versus application of platelet-rich fibrin without primary wound closure (no case of postoperative MRONJ in either group); and subperiosteal wound closure versus epiperiosteal wound closure (RR 0.09, 95% CI 0.00 to 1.56, 132 participants). Treatment of MRONJ Eight RCTs examined different interventions for the treatment of established MRONJ; that is, the effect on MRONJ cure rates. One RCT analysed hyperbaric oxygen (HBO) treatment used in addition to standard care (antiseptic rinses, antibiotics, and surgery) compared with standard care alone (at last follow-up: RR 1.56, 95% CI 0.77 to 3.18, 46 participants). Healing rates from MRONJ were not significantly different between autofluorescence-guided bone surgery and conventional bone surgery (RR 1.08, 95% CI 0.85 to 1.37, 30 participants). Another RCT that compared autofluorescence- with tetracycline fluorescence-guided sequestrectomy for the surgical treatment of MRONJ found no significant difference (at one-year follow-up: RR 1.05, 95% CI 0.86 to 1.30, 34 participants). Three RCTs investigated the effect of growth factors and autologous platelet concentrates on healing rates of MRONJ: platelet-rich fibrin after bone surgery versus surgery alone (RR 1.05, 95% CI 0.90 to 1.22, 47 participants), bone morphogenetic protein-2 together with platelet-rich fibrin versus platelet-rich fibrin alone (RR 1.10, 95% CI 0.94 to 1.29, 55 participants), and concentrated growth factor and primary wound closure versus primary wound closure only (RR 1.38, 95% CI 0.81 to 2.34, 28 participants). Two RCTs focused on pharmacological treatment with teriparatide: teriparatide 20 μg daily versus placebo in addition to standard care (RR 0.96, 95% CI 0.31 to 2.95, 33 participants) and teriparatide 56.5 μg weekly versus teriparatide 20 μg daily in addition to standard care (RR 1.60, 95% CI 0.25 to 1.44, 12 participants).

Authors conclusions: Prophylaxis of medication-related osteonecrosis of the jaw One open-label RCT provided some evidence that dental examinations at three-month intervals and preventive treatments may be more effective than standard care for reducing the incidence of medication-related osteonecrosis of the jaw (MRONJ) in individuals taking intravenous bisphosphonates for advanced cancer. We assessed the certainty of the evidence to be very low. There is insufficient evidence to either claim or refute a benefit of the interventions tested for prophylaxis of MRONJ in patients with antiresorptive therapy undergoing dentoalveolar surgery. Although some interventions suggested a potential large effect, the studies were underpowered to show statistical significance, and replication of the results in larger studies is pending. Treatment of medication-related osteonecrosis of the jaw The available evidence is insufficient to either claim or refute a benefit, in addition to standard care, of any of the interventions studied for the treatment of MRONJ.

Trial registration: ClinicalTrials.gov NCT00462098 NCT04531800 NCT01526915 NCT02198001 NCT03040778 NCT03269214 NCT03390777 NCT04512638.

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Conflict of interest statement

There are no financial conflicts of interest and the review authors declare that they do not have any associations with any parties who may have vested interests in the results of this review.

  1. Natalie H Beth‐Tasdogan: no interests to declare

  2. Benjamin Mayer: no interests to declare

  3. Heba Hussein: no interests to declare

  4. Jens‐Uwe Peter: no interests to declare

  5. Oliver Zolk: no interests to declare

Figures

1
1
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study
1.1
1.1. Analysis
Comparison 1: Dental examinations at three‐month intervals and preventive treatments (experimental) versus standard care (control) for prophylaxis of MRONJ, Outcome 1: MRONJ (incidence proportion)
1.2
1.2. Analysis
Comparison 1: Dental examinations at three‐month intervals and preventive treatments (experimental) versus standard care (control) for prophylaxis of MRONJ, Outcome 2: MRONJ (incidence rate: MRONJ cases per patient‐year)
2.1
2.1. Analysis
Comparison 2: Plasma rich in growth factors inserted into the postextraction alveolus in addition to standardised medical and surgical care (experimental) versus standardised medical and surgical care alone (control) for prophylaxis of MRONJ, Outcome 1: MRONJ (incidence proportion)
3.1
3.1. Analysis
Comparison 3: Subperiosteal wound closure versus epiperiosteal wound closure after tooth extraction for prevention of MRONJ in patients on antiresorptive treatment, Outcome 1: MRONJ after tooth extraction (assessed with: absence of complete mucosal integrity) at 6 months
4.1
4.1. Analysis
Comparison 4: Hyperbaric oxygen as an adjunct to conventional therapy (experimental) versus conventional therapy (control) for treatment of MRONJ, Outcome 1: Healing of MRONJ at last contact
5.1
5.1. Analysis
Comparison 5: Autofluorescence‐guided bone surgery (experimental) versus tetracycline fluorescence‐guided bone surgery (control) for treatment of MRONJ, Outcome 1: Healing of MRONJ (defined as mucosal integrity) at 1 year
6.1
6.1. Analysis
Comparison 6: Bone morphogenetic protein‐2 together with platelet‐rich fibrin (experimental) compared to platelet‐rich fibrin alone (control) for treatment of MRONJ., Outcome 1: Healing of MRONJ (defined as full mucosal coverage without clinical or radiographical evidence of MRONJ) after 16 weeks
7.1
7.1. Analysis
Comparison 7: Autofluorescence‐guided surgery (experimental) compared to conventional surgery (control) for treatment of MRONJ, Outcome 1: Healing of MRONJ (defined as full mucosal coverage and no signs of residual infection) at 1 year
8.1
8.1. Analysis
Comparison 8: Platelet‐rich fibrin after bone surgery (experimental) compared to surgery alone (control) for treatment of MRONJ, Outcome 1: Healing of MRONJ (defined as absence of infection and mucosal integrity without fistula) at 1 year
8.2
8.2. Analysis
Comparison 8: Platelet‐rich fibrin after bone surgery (experimental) compared to surgery alone (control) for treatment of MRONJ, Outcome 2: Healing of MRONJ (defined as absence of infection, mucosal integrity without fistula,  and no need for re‐intervention) at 1 year
9.1
9.1. Analysis
Comparison 9: Concentrated growth factor and primary wound closure (experimental) versus primary wound closure only (control) for treatment of MRONJ, Outcome 1: Healing of MRONJ (assessed with: mucosal integrity) at 6 months
10.1
10.1. Analysis
Comparison 10: Teriparatide 20 μg daily (experimental) versus placebo (control), in addition to standard care, for treatment of MRONJ, Outcome 1: Healing of MRONJ (defined as absence of any unresolved lesion) at 1 year
11.1
11.1. Analysis
Comparison 11: Teriparatide 56.5 μg weekly (experimental) versus teriparatide 20 μg daily (control), in addition to standard care, for treatment of MRONJ, Outcome 1: Healing of MRONJ (defined as partial or complete remission) at 6 months
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Ristow 2020 {published data only}DRKS00010106
    1. DRKS00010106. Comparison of two different mucosal closure techniques after tooth extraction in high risk patients with antiresortive medication intake - a prospective, randomized, blinded feasebility [sic] study. trialsearch.who.int/Trial2.aspx?TrialID=DRKS00010106 (first received 31 August 2020).
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Sim 2020 {published data only}ACTRN12612000950864
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References to studies excluded from this review

Asaka 2017 {published data only}
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Dimopoulos 2009 {published data only}
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Garcia‐Martinez 2017 {published data only}
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Jung 2017 {published data only}
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Lee 2014 {published data only}
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Nica 2021 {published data only}
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Pelaz 2014 {published data only}
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Rodriguez 2019 {published data only}
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Szentpeteri 2020 {published data only}
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Vescovi 2010 {published data only}
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Vescovi 2012 {published data only}
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References to ongoing studies

ChiCTR1900027382 {unpublished data only}
    1. Clinical study of modified curettage for medication-related osteonecrosis of the jaw. www.chictr.org.cn/showproj.aspx?proj=45608 11 November 2019. [CHICTR: ChiCTR1900027382]
DRKS00012888 {unpublished data only}
    1. DRKS00012888. Treatment strategies for medication-related osteonecrosis of the jaw - a prospective, partially randomized patient preference trial [Vergleich der chirurgischen und nicht-chirurgischen Therapie bei Patienten mit medikamenten-assoziierter Kiefernekrose – Eine prospektive, partiell randomisierte, Patientenpräferenz-Studie]. www.who.int/trialsearch/Trial2.aspx?TrialID=DRKS00012888 (first received 17 May 2018). [DRKS: DRKS00012888]
jRCTs071200006 {unpublished data only}jRCTs071200006
    1. jRCTs071200006. Investigation of the preventive effects of antimicrobial penetrated collargen plug(TERUPLUG) for post-extraction tooth socket for osteonecrosis of the jaw after tooth extraction in patients using high-dose antiresorptive agent [sic]. rctportal.niph.go.jp/en/detail?trial_id=jRCTs071200006 (first received 20 April 2020).
NCT01526915 {unpublished data only}
    1. NCT01526915. Assessment of platelet rich fibrin efficiency on healing delay and on jawbone osteochemonecrosis provoked by bisphosphonates (OCN/PRF). clinicaltrials.gov/ct2/show/record/NCT01526915 (first received 31 January 2012).
NCT02198001 {unpublished data only}
    1. NCT02198001. Prospective randomized study: assessment of PRF efficacy in prevention of jaw osteonecrosis after tooth extraction (PRF). clinicaltrials.gov/ct2/show/record/NCT02198001 (first received 15 July 2014).
NCT03040778 {unpublished data only}
    1. Pentoxifylline and Tocopherol (PENTO) in the treatment of Medication-related Osteonecrosis of the Jaw (MRONJ). clinicaltrials.gov/show/nct03040778 February 2, 2017.
NCT03269214 {unpublished data only}
    1. NCT03269214. Use of topical phenytoin in bisphosphonate-related osteonecrosis of the mandible. clinicaltrials.gov/ct2/show/NCT03269214 August 31, 2017.
NCT03390777 {unpublished data only}
    1. Plasma rich in growth factors for treatment of medication related osteonecrosis of the jaw. clinicaltrials.gov/show/nct03390777 January 4, 2018 . [CLINICALTRIALS.GOV: NCT03390777]
NCT04512638 {published data only}
    1. NCT04512638. Best Treatment Choice for Osteonecrosis of the Jaw (BETCON). clinicaltrials.gov/ct2/show/NCT04512638 (first received 13 August 2020).
NCT04531800 {unpublished data only}
    1. NCT04531800. Surgical management of medication related osteonecrosis of the jaws with concentrated growth factor. clinicaltrials.gov/ct2/show/NCT04531800 (first received 31 August 2020).
UMIN000009132 {unpublished data only}
    1. Study to the effect of teriparatide formulation Forteo versus Teribon on bisphosphonate-related osteonecrosis of the jaw in osteoporosis patients. upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=bro... (first received 17 October 2012).
UMIN000042862 {published data only}UMIN000042862
    1. The clinical effect of teriparatide on BRONJ (bisphosphonate-related osteonecrosis of the jaw). https://rctportal.niph.go.jp/en/detail?trial_id=UMIN000042862 27/12/2020. [UMIN-CTR: UMIN000042862]

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