Guidelines in Specific Procedures: Antibiotic Prophylaxis, MRONJ, Sedation and General Anesthesia
Antibiotic Prophylaxis Prior to Dental Procedures
Among some patients, there are formal recommendations. Recommendations for antibiotic prophylaxis prior to certain dental procedures exist primarily for two groups:
• patients with heart conditions that may predispose them to infective endocarditis; and
• patients who have a prosthetic joint(s) and may be at risk for developing hematogenous infections at the site of the prosthetic.
However, compared with earlier iterations, the current recommendations identify relatively few patient subpopulations within these groups for whom antibiotic prophylaxis may be indicated.
1 | Prevention of Prosthetic Joint Infection
In 2014, the ADA Council on Scientific Affairs assembled an expert panel to update and clarify the clinical recommendations found in the 2012 evidence report and 2013 guideline: Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures (see Suggested Reading List).
As was found in 2012, the updated systematic review published in 2015 found no association between dental procedures and prosthetic joint infections. Based on this evidence review, the 2015 ADA clinical practice guideline states, “In general, for patients with prosthetic joint implants, prophylactic antibiotics are not recommended prior to dental procedures to prevent prosthetic joint infection.”
In 2017, an ADA-appointed panel of experts published a commentary in JADA (see Suggested Reading List), offering guidance for using the American Academy of Orthopaedic Surgeons’ “appropriate use criteria,” which address managing care for patients with orthopedic implants undergoing dental procedures (see Suggested Reading List). The JADA piece calls the appropriate use criteria “a decision-support tool to supplement clinicians in their judgment” and it emphasizes discussion of available treatment options between the patient, dentist and orthopedic surgeon, weighing the potential risks and benefits. The commentary encourages dentists to continue to use the 2015 guideline, consult the appropriate use criteria as needed, and respect the patient’s specific needs and preferences when considering antibiotic prophylaxis before dental treatment.
According to the ADA Chairside Guide developed by the Center for Evidence-based Dentistry (see Suggested Reading List), “for patients with a history of complications associated with their joint replacement surgery who are undergoing dental procedures that include gingival manipulation or mucosal incision, prophylactic antibiotics should only be considered after consultation with the patient and orthopedic surgeon.” Further, in cases where antibiotics are deemed necessary, it is most appropriate that the orthopedic surgeon recommend the antibiotic regimen and, when reasonable, write the prescription.
2 | Prevention of Infective Endocarditis
With input from the ADA, the American Heart Association (AHA) released guidelines for the prevention of infective endocarditis in 2007, which were approved by the CSA as they relate to dentistry in 2008. In 2017, the AHA and American College of Cardiology (ACC) published a focused update to their 2014 guidelines on the management of valvular heart disease that reinforce the previous recommendations.
These current guidelines support infective endocarditis premedication for a relatively small subset of patients. This is based on a review of scientific evidence, which showed that the risk of adverse reactions to antibiotics generally outweigh the benefits of prophylaxis for many patients who would have been considered eligible for prophylaxis in previous versions of the guidelines. Concern about the development of drug-resistant bacteria also was a factor.
Also, the data are inconsistent as to whether prophylactic antibiotics taken before a dental procedure prevent infective endocarditis. The guidelines note that people who are at risk for infective endocarditis are regularly exposed to oral bacteria during basic daily activities such as brushing or flossing.
The valvular disease management guidelines recommend that persons at risk of developing bacterial infective endocarditis (Box 1) establish and maintain the best possible oral health to reduce potential sources of bacterial seeding. They state, “Optimal oral health is maintained through regular professional dental care and the use of appropriate dental products, such as manual, powered, and ultrasonic toothbrushes; dental floss; and other plaque-removal devices.”
3 | Dental Procedures
Prophylaxis is recommended for the patients identified in the previous section for all dental procedures that involve manipulation of gingival tissue or the periapical region of the teeth, or perforation of the oral mucosa. Refer to Antibiotics chapter (Chapter 2) for more information.
The current infective endocarditis/valvular heart disease guidelines state that use of preventive antibiotics before certain dental procedures is reasonable for patients with:
• prosthetic cardiac valves, including transcatheter-implanted prostheses and homografts
• prosthetic material used for cardiac valve repair, such as annuloplasty rings and chords
• a history of infective endocarditis
• a cardiac transplant* with valve regurgitation due to a structurally abnormal valve;
• the following congenital (present from birth) heart disease:**
– unrepaired cyanotic congenital heart disease, including palliative shunts and conduits
– any repaired congenital heart defect with residual shunts or valvular regurgitation at the site of or adjacent to the site of a prosthetic patch or a prosthetic device
* According to limited data, infective endocarditis appears to be more common in heart transplant recipients than in the general population; the risk of infective endocarditis is highest in the first 6 months after transplant because of endothelial disruption, high-intensity immunosuppressive therapy, frequent central venous catheter access, and frequent endomyocardial biopsies.
** Except for the conditions listed above, antibiotic prophylaxis is not recommended for any other form of congenital heart disease.
| Suggested Reading
• American Academy of Orthopaedic Surgeons. Appropriate Use Criteria: Management of Patients with Orthopaedic Implants Undergoing Dental Procedures. aaos.webauthor.com/go/auc/terms.cfm?auc_id=224995&actionxm=Terms. Accessed August 3, 2018.
• American Academy of Orthopaedic Surgeons; American Dental Association. Prevention of orthopaedic implant infection in patients undergoing dental procedures: evidence-based guideline and evidence report. Rosemont, IL: American Academy of Orthopaedic Surgeons; 2012. Available at: www.aaos.org/Research/guidelines/PUDP/PUDP_guideline.pdf. Accessed August 3, 2018.
• American Dental Association-Appointed Members of the Expert Writing and Voting Panels Contributing to the Development of American Academy of Orthopedic Surgeons Appropriate Use Criteria. American Dental Association guidance for utilizing appropriate use criteria in the management of the care of patients with orthopedic implants undergoing dental procedures. J Am Dent Assoc 2017;148(2):57-59.
• American Dental Association Center for Evidence-Based Dentistry. Chairside Guide, 2015. ebd.ada.org/~/media/EBD/Images/Chairside%20Guides/ADA_ Chairside_Guide_Prosthetics.pdf?la=en.
• Meyer DM. Providing clarity on evidence-based prophylactic guidelines for prosthetic joint infections. J Am Dent Assoc 2015;146(1):3-5.
• Sollecito TP, Abt E, Lockhart PB, et al. The use of prophylactic antibiotics prior to dental procedures in patients with prosthetic joints: Evidence-based clinical practice guideline for dental practitioners–a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc 2015;146(1):11-16 e8.
• Wilson W, Taubert KA, Gewitz M, et al. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis, and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Circulation 2007;116(15):1736-54.
• Wilson W, Taubert KA, Gewitz M, et al. Prevention of infective endocarditis: guidelines from the American Heart Association: a guideline from the American Heart Association Rheumatic Fever, Endocarditis and Kawasaki Disease Committee, Council on Cardiovascular Disease in the Young, and the Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and the Quality of Care and Outcomes Research Interdisciplinary Working Group. J Am Dent Assoc 2008;139 Suppl:3S-24S.
In 2014, the American Association of Oral and Maxillofacial Surgeons (AAOMS) updated their definition of Medication-Related Osteonecrosis of the Jaw (MRONJ) (see Ruggiero et al in Suggested Reading List) to include all of the following criteria: (1) current or previous treatment with antiresorptive or antiangiogenic agents; (2) exposed bone or bone that can be probed through an intraoral or extraoral fistula(e) in the maxillofacial region that has persisted for more than 8 weeks; and (3) no history of radiation therapy to the jaws or obvious metastatic disease to the jaws.
The reported incidence of MRONJ varies, but it is generally considered to be between 1% and 10% of patients taking IV bisphosphonates for the management of bone metastatic disease and between 0.001% and 0.01% in patients taking oral bisphosphonates for the management of osteoporosis.
The differential diagnosis of MRONJ includes other conditions such as alveolar osteitis, sinusitis, gingivitis/periodontitis, or periapical pathosis. According to a 2015 systematic review and international consensus paper by Khan et al. (see Suggested Reading List), patient history and clinical examination remain the most sensitive diagnostic tools for MRONJ. While it is not possible to identify who will develop MRONJ and who will not, research suggests the following as risk factors:
• age older than 65 years
• recent dentoalveolar surgery, including tooth extraction
• high dose and/or prolonged use of antiresorptive agents (i.e., more than 2 years)
• receiving antiresorptive therapy in conjunction with antiangiogenic drugs for cancer
• malignant disease (multiple myeloma, and breast, prostate, and lung cancer)
• chemotherapy, corticosteroid therapy, or treatment with antiangiogenic agents
• denture wearing
1 | Dental Patients Receiving Antiresorptive Medications for Osteoporosis
In November 2011, the ADA Council on Scientific Affairs (CSA) Expert Panel on Antiresorptive Agents published recommendations for managing the dental care of patients receiving antiresorptive therapy specifically for the prevention and treatment of osteoporosis (i.e., not addressing the dental care of patients being treated with antiresorptive agents as part of cancer therapy)(see Suggested Reading List). These recommendations were based on a narrative review of the literature from May 2008 (the date of the last search for a 2008 review and statement) through February 2011.
Although the 2008 report limited the review to jaw osteonecrosis related to bisphosphonates, the 2011 report expanded the search to include jaw osteonecrosis related to the use of any antiresorptive agent (including denosumab and cathepsin K inhibitors).
The CSA report found that the highest reliable estimate of MRONJ prevalence is low (approximately 0.10%) in patients receiving drug dosages and regimens intended to treat or prevent osteoporosis. The CSA concluded that the potential morbidity and mortality associated with osteoporosis-related fracture is considerable and treatment with antiresorptive agents, including bisphosphonates, outweighs the low risk of MRONJ in patients with osteoporosis being treated with these drugs. The report states that “An oral health program consisting of sound hygiene practices and regular dental care may be the optimal approach for lowering [MRONJ] risk” in these patients and that a discussion of the risks and benefits of dental care with patients receiving antiresorptive therapy is appropriate. The report provides the following points that dental practitioners can discuss with patients:
• Antiresorptive therapy for low bone mass places patients at a low risk of developing drug-related ONJ
• The low risk of MRONJ can be reduced, but not eliminated
• An oral health program consisting of sound oral hygiene practices and regular dental care may lower the risk of drug-related ONJ
• As of this writing, no validated prognostic tool is available to determine which patients are at increased risk of developing drug-related ONJ
• Due to the cumulative effect of bisphosphonates in the bone, discontinuing bisphosphonate therapy may not eliminate the risk of developing drug-related ONJ and that discontinuation of bisphosphonate therapy may have a negative impact on the outcomes of treatment for low bone mass
Because of the paucity of clinical data regarding the dental care of patients receiving antiresorptive therapy, the report also describes management recommendations based primarily on expert opinion for general prevention and treatment planning, as well as for specific conditions, such as management of periodontal disease, oral and maxillofacial surgery, endodontics, restorative dentistry and prosthodontics, and orthodontics (Table 1). There is insufficient evidence to recommend a “holiday” from antiresorptive drug therapy for osteoporosis or waiting periods before performing dental treatment for prevention of MRONJ. There is also insufficient evidence to recommend the use of serum biomarker tests, such as serum C-terminal telopeptide (CTX) as a predictor of MRONJ risk in patients receiving the drugs for osteoporosis indications.
General Prevention and Treatment Planning:
• Have a discussion with patients regarding potential risks and benefits
• Do not modify routine dental treatment solely because of osteoporosis antiresorptive medications
• A localized clinical approach (e.g., treating a sextant at a time) to dentoalveolar surgery in patients receiving antiresorptive therapy for low bone density may help assess risk (Note, the sextant-by-sextant approach does not apply to emergency cases, even if multiple quadrants are involved)
• Treat periapical pathoses, sinus tracts, purulent periodontal pockets, severe periodontitis and active abscesses that already involve the medullary bone expeditiously
• Obtain access to root surfaces using atraumatic techniques that minimize dentoalveolar manipulation whenever possible
• Use techniques such as guided tissue regeneration or bone grafting judiciously based on patient need
• Primary soft-tissue closure after periodontal surgical procedures is desirable, when feasible, although extended periosteal bone exposure for the sake of primary closure may increase, rather than decrease, the risk of developing MRONJ
Implant Placement and Maintenance:
• Antiresorptive therapy does not appear to be a contraindication for dental implant placement; however, larger and longer-term studies are needed to determine if implants placed in patients exposed to antiresorptive agents perform as well as those placed in patients who have not been exposed to these agents
Oral and Maxillofacial Surgery:
• If extractions or bone surgery is necessary, dentists should consider a conservative surgical technique with primary tissue closure, when feasible
• Placement of semipermeable membranes over extraction sites also may be appropriate if primary closure is not possible
• Before and after any surgical procedures involving bone, the patient should rinse gently with a chlorhexidine-containing rinse until the extraction site has healed
• In patients with an elevated risk of developing MRONJ, endodontic treatment is preferable to surgical manipulation if a tooth is salvageable
• Practitioners should use a routine endodontic technique; however, the panel does not recommend manipulation beyond the apex
Restorative Dentistry and Prosthodontics:
• Practitioners should perform all routine restorative procedures with the goal of minimizing the impact on bone, so as not to increase the risk of infection
• To avoid ulceration and possible bone exposure, practitioners should adjust prosthodontic appliances promptly for fit
• Inhibited tooth movement in adult patients receiving bisphosphonate therapy has been reported and dentists should advise patients of this potential complication; however, orthodontic procedures have been performed successfully in patients receiving antiresorptive therapy, and it is not necessarily contraindicated
• Orthognathic surgery and tooth extractions result in more extensive bone healing and remodeling; treatment planning in these cases may require increased vigilance
* Hellstein JW, Adler RA, Edwards B, et al. Managing the care of patients receiving antiresorptive therapy for prevention and treatment of osteoporosis: Recommendations from the American Dental Association Council on Scientific Affairs (Narrative review). November 2011. (www.aae.org/uploadedfiles/publications_and_research/endodontics_colleagues_for_excellence_newsletter/bonj_ada_report.pdf. Accessed August 3, 2018.)
In 2014, AAOMS published a position paper on MRONJ (see Ruggiero et al., Suggested Reading List). The position paper was based on a literature review and expert opinion/observations of a multidisciplinary committee including surgeons, pathologists, and oncologists. Although the authors cautioned that the position paper was informational in nature and not intended to set any standards of care, they did provide suggestions for potential prevention strategies for patients based on limited evidence, including implementation of dental screening and appropriate dental interventions before initiating antiresorptive and/or antiangiogenic therapies. In patients receiving antiresorptive and/or antiangiogenic medications for cancer-related indications, increased awareness, preventive dental care, and early recognition of the signs and symptoms of MRONJ may result in earlier detection.
The AAOMS committee outlined the following measures as part of early treatment planning in these patients:
• thorough examination of the oral cavity and a radiographic assessment when indicated
• identification of acute infection and sites of potential infection to prevent future sequelae that could be exacerbated once drug therapy begins
• patient motivation and patient education regarding dental care
The AAOMS article by Ruggiero et al. states that if “systemic conditions permit, initiation of antiresorptive therapy should be delayed until dental health is optimized” and that “This decision must be made in conjunction with the treating physician and dentist and other specialists involved in the care of the patient” (see Suggested Reading List) Regarding antiangiogenic therapy, the AAOMS states, “There are no data to support or refute the cessation of antiangiogenic therapy in the prevention or management of MRONJ; therefore, continued research in the area is indicated.”
A systematic review and international consensus paper from the International Task Force on Osteonecrosis of the Jaw published in early 2015 also suggests that key prevention strategies for MRONJ include elimination or stabilization of oral disease prior to initiation of antiresorptive agents, as well as maintenance of good oral hygiene (See Khan, Suggested Reading List). For patients whose cancer management includes treatment with denosumab or IV bisphosphonates, the Task Force recommends that “a thorough dental examination with dental radiographs should be ideally completed prior to the initiation of antiresorptive therapy in order to identify dental disease before drug therapy is initiated” and that “Any necessary invasive dental procedure including dental extractions or implants should ideally be completed prior to initiation of [bisphosphonate] or [denosumab] therapy.”
The Task Force also states that, “Non-urgent procedures should be assessed for optimal timing because it may be appropriate to complete the non-urgent procedure prior to osteoclast inhibition, delay it until it is necessary, or perhaps plan for it during a drug holiday; however, there are no compelling data to guide these decisions.”
• Beth-Tasdogan NH, Mayer B, Hussein H, Zolk O. Interventions for managing medication-related osteonecrosis of the jaw. Cochrane Database Syst Rev 2017;10:Cd012432.
• Hellstein JW, Adler RA, Edwards B, et al. Managing the care of patients receiving antiresorptive therapy for prevention and treatment of osteoporosis: Recommendations from the American Dental Association Council on Scientific Affairs (Narrative review). November 2011. www.aae.org/uploadedfiles/publications_and_research/endodontics_colleagues_for_excellence_newsletter/bonj_ada_report.pdf.
• Hellstein JW, Adler RA, Edwards B, et al. Managing the care of patients receiving antiresorptive therapy for prevention and treatment of osteoporosis: executive summary of recommendations from the American Dental Association Council on Scientific Affairs. J Am Dent Assoc 2011;142(11):1243-51.
• Khan AA, Morrison A, Hanley DA, et al. Diagnosis and management of osteonecrosis of the jaw: a systematic review and international consensus. J Bone Miner Res 2015;30(1):3-23.
• No Authors Listed. Osteoporosis medications and your dental health. J Am Dent Assoc 2011;142(11):1320.
• Ruggiero SL, Dodson TB, Fantasia J, et al. American Association of Oral and Maxillofacial Surgeons position paper on medication-related osteonecrosis of the jaw–2014 update. J Oral Maxillofac Surg 2014;72(10):1938-56.
• Yamashita J, McCauley LK. Antiresorptives and osteonecrosis of the jaw. J Evid Based Dent Pract 2012;12(3 Suppl):233-47.
Excerpted from: American Dental Association. ADA Guidelines for the Use of Sedation and General Anesthesia by Dentists, October 2016.
The administration of local anesthesia, sedation and general anesthesia is an integral part of dental practice. The American Dental Association is committed to the safe and effective use of these modalities by appropriately educated and trained dentists. The purpose of these guidelines is to assist dentists in the delivery of safe and effective sedation and anesthesia (Box 2).
Dentists must comply with their state laws, rules and/or regulations when providing sedation and anesthesia
Level of sedation is entirely independent of the route of administration. Moderate and deep sedation or general anesthesia may be achieved via any route of administration and thus an appropriately consistent level of training must be established.
For children, the American Dental Association supports the use of the American Academy of Pediatrics/American Academy of Pediatric Dentistry Guidelines for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.
A. Minimal Sedation
1. Patient History and Evaluation
Patients considered for minimal sedation must be suitably evaluated prior to the start of any sedative procedure. In healthy or medically stable individuals (ASA I, II)2 this should consist of a review of their current medical history and medication use. In addition, patients with significant medical considerations (ASA III, IV)2 may require consultation with their primary care physician or consulting medical specialist.
2. Preoperative Evaluation and Preparation
• The patient, parent, legal guardian or care giver must be advised regarding the procedure associated with the delivery of any sedative agents and informed consent for the proposed sedation must be obtained.
• Determination of adequate oxygen supply and equipment necessary to deliver oxygen under positive pressure must be completed.
• An appropriate focused physical evaluation should be performed.
• Baseline vital signs including body weight, height, blood pressure, pulse rate, and respiration rate must be obtained unless invalidated by the nature of the patient, procedure or equipment. Body temperature should be measured when clinically indicated.
• Preoperative dietary restrictions must be considered based on the sedative technique prescribed.
• Preoperative verbal and written instructions must be given to the patient, parent, escort, legal guardian or caregiver.
Personnel: At least one additional person trained in Basic Life Support for Healthcare Providers must be present in addition to the dentist.
• A positive-pressure oxygen delivery system suitable for the patient being treated must be immediately available.
• Documentation of compliance with manufacturers’ recommended maintenance of monitors, anesthesia delivery systems, and other anesthesia-related equipment should be maintained. A pre-procedural check of equipment for each administration of sedation must be performed.
• When inhalation equipment is used, it must have a fail-safe system that is appropriately checked and calibrated. The equipment must also have either (1) a functioning device that prohibits the delivery of less than 30% oxygen or (2) an appropriately calibrated and functioning in-line oxygen analyzer with audible alarm.
• An appropriate scavenging system must be available if gases other than oxygen or air are used.
4. Monitoring and Documentation
Monitoring: A dentist, or at the dentist’s direction, an appropriately trained individual, must remain in the operatory during active dental treatment to monitor the patient continuously until the patient meets the criteria for discharge to the recovery area. The appropriately trained individual must be familiar with monitoring techniques and equipment. Monitoring must include:
• Consciousness: Level of sedation (e.g., responsiveness to verbal commands) must be continually assessed.
• Oxygenation: Oxygen saturation by pulse oximetry may be clinically useful and should be considered.
– The dentist and/or appropriately trained individual must observe chest excursions.
– The dentist and/or appropriately trained individual must verify respirations.
• Circulation: Blood pressure and heart rate should be evaluated preoperatively, postoperatively and intraoperatively as necessary (unless the patient is unable to tolerate such monitoring).
Documentation: An appropriate sedative record must be maintained, including the names of all drugs administered, time administered and route of administration, including local anesthetics, dosages, and monitored physiological parameters.
• Oxygen and suction equipment must be immediately available if a separate recovery area is utilized.
• The qualified dentist or appropriately trained clinical staff must monitor the patient during recovery until the patient is ready for discharge by the dentist.
• The qualified dentist must determine and document that level of consciousness, oxygenation, ventilation and circulation are satisfactory prior to discharge.
• Postoperative verbal and written instructions must be given to the patient, parent, escort, legal guardian or care giver.
6. Emergency Management
• If a patient enters a deeper level of sedation than the dentist is qualified to provide, the dentist must stop the dental procedure until the patient returns is returned to the intended level of sedation.
• The qualified dentist is responsible for the sedative management, adequacy of the facility and staff, diagnosis and treatment of emergencies related to the administration of minimal sedation and providing the equipment and protocols for patient rescue.