Mary Ann Hanlon, DDS, MS
Practice Limited to Periodontics
5213 North Bend Road Cincinnati, Ohio 45247
Tel (513) 662-4867
Fax (513) 662-3070
cinciperio.com
INFORMED CONSENT FOR PERIODONTAL PROCEDURES IN PATIENTS
ON ANTIRESORPTIVE THERAPY
ARONJ (anti resorptive agent-induced osteonecrosis of the jaw) is defined as “exposed
bone in the maxillofacial region persisting for more than eight weeks in a patient who is
taking, or who has taken, any antiresorptive agent and has not had radiation therapy to the
head and neck”. Clinical signs and symptoms of ARONJ typically include varying
reports of pain, soft tissue swelling and infection, loosening of teeth, halitosis, drainage
and exposed bone. Symptoms may spontaneously occur in the bone; or more commonly,
at a non-healing site following a procedure that caused bone trauma. In some cases,
clinical features of osteonecrosis may be absent. PLEASE INFORM DR. HANLON IF
YOU DEVELOP ANY OF THE ABOVE SIGNS AND SYMPTOMS AT ANY TIME.
(for the purposes of this consent, bisphosphonates are considered antiresorptive
agents)
ARONJ risk factors/comorbidities include: diabetes mellitus, clinically and
radiographically apparent periodontitis, tooth extractions, denture wearing and smoking.
It may also spontaneously occur in patients with minor mucosal irritation, such as that
from dentures.
To date, studies have consistently shown that the risk for developing ARONJ is higher
for cancer patients on IV bisphosphonate therapy than for patients on oral bisphosphonate
therapy for low bone density. Current estimates of ARONJ in non cancer patients are as
high as 0.10%. There is thought to be a fourfold increase in the risk for ARONJ in cancer
patients treated intravenously with bisphosphonates. However, it is difficult to predict
risk in general, and impossible to predict an individual patient’s risk.
The following recommendations (made by an ADA expert panel), are intended to help
dentists and periodontists make the best clinical decisions for their patients.
*Antiresorptive therapy for low bone mass use places patients at low risk for
developing ARONJ (highest prevalence estimate is 0.10%).
*The low risk for developing ARONJ can be minimized but not eliminated.
*An oral health program consisting of sound oral hygiene practices and regular
dental care may be the optimal approach for lowering the risk for developing
ARONJ.
*There is no validated diagnostic technique currently available to determine
which patients are at increased risk for developing ARONJ.
*Discontinuing bisphosphonate therapy may not eliminate any risk for developing
ARONJ. However, it may have a negative impact on the outcomes of low bone
mass treatment. Therefore, significant dental risks need to be present to consider
cessation of antiresorptive therapy for low bone mass, cancer or other off-label
therapies. Discussion with all members of the healthcare team is recommended
prior to discontinuing therapy.
The patient should be informed of the dental treatment needed, alternative treatments,
how any treatment relates to the risk of ARONJ, other risks associated with various
treatment options and the risk of foregoing treatment, even temporarily. The patient
should be encouraged to consult with his/her physician about health risks associated with
discontinuation of antiresorptive therapy. All decisions with respect to utilization of
drugs prescribed for medical conditions should be discussed with the prescribing
physician.
When conservative treatment of dental and/or periodontal diseases has failed, surgical
intervention may be the best alternative. Patients receiving antiresorptive therapy who
are undergoing invasive surgical procedures should be informed of the risk, albeit slight,
of developing ARONJ. Alternative treatment plans should be discussed with the patient,
including endodontics, allowing the roots to exfoliate and use of fixed and removable
partial dentures. If extractions or bone surgery are necessary, conservative surgical
technique, with primary closure, when feasible, should be considered. Before and after
any surgical procedures involving bone, the patient should gently rinse with
chlorhexidine-containing rinse until healed. There is some evidence that antibiotic
prophylaxis may be effective in preventing ARONJ.
Your risk of developing ARONJ is very small, unless you are on an intravenous form of
antiresorptive therapy. You may be at increased risk for developing other health
problems if a dental disease is not treated. Dr. Hanlon has discussed alternative
treatments, other risks associated with various treatment options and the risk of no
treatment, even temporarily. You have also had the opportunity to discuss any health
risks with your treating physician.
____ I have reviewed the above information and have had the opportunity to have any
questions/concerns addressed. Based on the information presented by Dr. Hanlon and her
staff regarding my diagnosis, the proposed treatment, the treatment alternatives, and the
associated risks and complications of such treatment, I request that you perform the
planned treatment.
Patient Signature
Date
Doctor Signature
Date
Witness Signature