- Email: [email protected]
Local anesthesia system for intraosseous injection
DENTAL PRODUCT SPOTLIGHT PREPARED BY THE ADA DIVISION OF SCIENCE ON BEHALF OF THE ADA COUNCIL ON SCIENTIFIC AFFAIRS
Local anesthesia system for intraosseous injection PRODUCT NAME Stabident and Alternative Stabident (received ADA Seal of Acceptance in May 2002) MANUFACTURER Fairfax Dental Inc., 2601 South Bayshore Drive, Suite 875, Miami, Fla. 33133, 1-800-233-2305, “www. stabident.com” Stabident is a local anesthesia system for intraosseous injection. The Stabident system is made up of a perforator (a special form of drill, approximately 27-gauge, that is handpiece-driven) and a matching injection needle. The Alternative Stabident system has an additional guide sleeve that is placed in the hole made by the perforator to guide the injection needle. These injection systems perforate the cortical plate so that local anesthetic may be injected into the cancellous bone. INDICATIONS AND CONTRAINDICATIONS FOR USE
dMaximum dosage is one cartridge per visit. Inject slowly and gently. dIf a local anesthetic solution that contains epinephrine is used, it is essential to inject it very slowly while the patient is in a supine position. A rapid injection of a solution containing epinephrine could result in palpitations and a feeling of faintness. dThe amount of local anesthetic required to produce anesthesia using the Stabident System is much less
ACCEPTED
“Stabident or Alternative Stabident is Accepted as an effective intraosseous injection device for providing pulpal anesthesia when used on its own or as a supplement to inferior alveolar nerve block. In cases of irreversible pulpitis, it is effective as a supplement to inferior alveolar nerve block.”—Council on Scientific Affairs, American Dental Association
than that required in infiltration and regional block methods. dPulpal anesthesia lasts 15 to 30 minutes. SAFETY AND EFFICACY DATA Published clinical studies have evaluated pulpal anesthesia achieved by intraosseous, or IO, injection with the Stabident system. These randomized, controlled clinical trials were conducted at The Ohio State University and enrolled between 38 and 51 patients. The Stabident IO injection was evaluated as a primary and as a supplemental injection. Guglielmo and colleagues1 found that IO injection of 1.8 milliliters of 2 percent lidocaine with 1:100,000 epinephrine or 2 percent mepivacaine with 1:20,000 levonordefrin, used to supplement an inferior alveolar nerve, or IAN, block, significantly increased anesthetic success in first molars and second premolars. Nusstein and colleagues2 found that a supplemental mandibular IO injection of 1.8 mL of 2 percent lidocaine with 1:100,000 epinephrine was 90 percent successful in gaining total pulpal anesthesia for teeth diagnosed with irreversible pulpitis. Gallatin and colleagues3 found that IO injection of 1.8 mL of 3 percent mepivacaine, when used to augment an IAN block, significantly increased anesthetic success for 30 minutes in the first molar. Reitz and colleagues4 found that supplemental IO injection of 0.9 mL of 2 percent lidocaine with 1:100,000 epinephrine distal to the second premolar significantly increased the success of pulpal anesthesia in the second premolar (for 50 minutes) and first molar (for 20 minutes) compared with the IAN block alone. Reisman and colleagues5 found that supplemental IO injection of 3 percent mepivacaine for mandibular posterior teeth with irreversible pulpitis resulted in anesthetic success of 80 percent compared with the 25 percent success of IAN block alone. Dunbar and colleagues6 reported that for mandibular first molars, an IO supplemental injection to an IAN block increased anesthetic success from 42 percent to 90 percent, and decreased the percentage of anesthetic failure from 32 percent with IAN alone to 0 percent with IAN plus IO. Coggins and colleagues7 found that IO injection alone provided pulpal anesthesia in 75 percent to 93 percent of noninflamed maxillary and mandibular teeth. OTHER APPROVALS AND CERTIFICATIONS Stabident and Alternative Stabident have received U.S. Food and Drug Administration Premarket Notification
The Dental Product Spotlight appears in JADA each month to help dentists stay current on new products entering the marketplace and receiving the ADA Seal of Acceptance. These reports are prepared by the ADA Division of Science, in cooperation with The Journal of the American Dental Association. All rights reserved.
982
JADA, Vol. 133, July 2002 Copyright ©2002 American Dental Association. All rights reserved.
DENTAL P R O D U C T
(510[k]) and the CE mark. (The CE mark is the official marking required by the European Community for all electric and electronic equipment that will be sold or put into service for the first time anywhere in the European Community. It proves to the buyer, or user, that the product fulfills all essential safety and environmental requirements as they are defined in the socalled European Directives. CE marked products are presumed to conform with the requirements of Directives and as such can be supplied anywhere in the European Community without further testing.) 1. Guglielmo A, Reader A, Nist R, Beck M, Weaver J. Anesthetic efficacy and heart rate effects of the supplemental intraosseous injection of 2 percent mepivacaine with 1:20,000 levonordefrin. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999;87:284-93.
Intraosseous injection Successful anesthesia during dental procedures can be difficult to achieve. Intraosseous injection has been shown to enhance anesthetic success significantly when used alone1-3 or as a supplement to conventional local anesthetic, particularly in cases of irreversible pulpitis.4-9 Anesthesia of the surrounding soft tissue, bone and teeth is achieved by the deposition of local anesthetic into the vascular spaces of the alveolar cancellous bone. EFFICACY When used alone, intraosseous injection of 1.8 milliliters 2 percent lidocaine with 1:100,000 epinephrine was shown to be 90 percent effective for anesthetizing maxillary molars and 75 percent effective for mandibular molars.2,9,10 As a supplemental injection, intraosseous deposition of 2 percent lidocaine with 1:100,000 epinephrine was 90 percent effective.8 Lip numbness reportedly is attenuated with intraosseous injection10 and tongue and cheek numbness reportedly do not occur.3 The onset of anesthesia is immediate, and the duration is from 15 to 30 minutes, depending on the presence of vasoconstrictors.2,10 All the clinical studies that evaluated the efficacy of intraosseous injections used the Stabident system.1-18 CARDIOVASCULAR EFFECTS Intraosseous injection of local anesthetic solutions containing vasoconstrictors (2 percent lidocaine with 1:100,000 epinephrine) caused a transient increase in heart rate in a majority of patients, but had no effect on blood pressure.1,4 The average increase was about 25 beats per minute and occurred during solution deposi-
SPOTLIGHT
2. Nusstein J, Reader A, Nist R, Beck M, Meyers WJ. Anesthetic efficacy of the supplemental intraosseous injection of 2 percent lidocaine with 1:100,000 epinephrine in irreversible pulpitis. J Endod 1998;24:487-91. 3. Gallatin E, Stabile P, Reader A, Nist R, Beck M. Anesthetic efficacy and heart rate effects of the intraosseous injection of 3 percent mepivacaine after an inferior alveolar nerve block. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2000;89:83-7. 4. Reitz J, Reader A, Nist R, Beck M, Meyers WJ. Anesthetic efficacy of a repeated intraosseous infection given 30 min. following an inferior alveolar nerve block/intraosseous injection. Anesth Prog 1998;45:143-9. 5. Reisman D, Reader A, Nist R, Beck M, Weaver J. Anesthetic efficacy of the supplemental intraosseous injection of 3 percent mepivacaine in irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997;84:676-82. 6. Dunbar D, Reader A, Nist R, Beck M, Meyers W. Anesthetic efficacy of the intraosseous injection after an inferior alveolar nerve block. J Endod 1996;22:481-6. 7. Coggins R, Reader A, Nist R, Beck M, Meyers WJ. Anesthetic efficacy of the intraosseous injection in maxillary and mandibular teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1996;81:634-41.
tion or within two minutes after solution deposition. The heart rate returned to normal within four minutes. The authors stated that this effect would not be clinically significant in most patients, but patients should be informed of the possible increase in heart rate to lessen their anxiety. In patients whose medical condition or therapeutic regimens contraindicate the use of epinephrine- or levonordefrin-containing solutions, mepivacaine can be used as an alternative anesthetic.1,4 INDICATIONS Primary intraosseous injections are useful for short procedures and for lessening the feeling of numbness.9 However, intraosseous injections are most useful for enhancing the efficacy and duration of anesthesia achieved by conventional methods, particularly in refractory cases.9 CONTRAINDICATIONS Intraosseous injections may be contraindicated in patients with severe periodontal disease or acute infection, a narrow zone of attached gingiva and crowded teeth.9,11 INFECTION No studies have evaluated the effect of intraosseous injection on gingiva and bone, but Dunbar and colleagues8 have found no incidence of infection after these injections. Coggins and colleagues10 found that 1.25 percent of the subjects (two of 160) required antibiotic administration owing to swelling and purulence at the injection site. Within 14 days, the sites had healed. MARKETED DEVICES There are three devices marketed for intraosseous injection: the Stabident System (see Dental Product Spotlight), Hypo Brand Intraosseous Needle (MPL Technologies, Franklin Park, Ill., “www.dentsply.com/ divisions/mpl.html”) and The IntraFlow Dental Anes-
JADA, Vol. 133, July 2002 Copyright ©2002 American Dental Association. All rights reserved.
983
Local anesthesia system for intraosseous injection PRODUCT NAME Stabident and Alternative Stabident (received ADA Seal of Acceptance in May 2002) MANUFACTURER Fairfax Dental Inc., 2601 South Bayshore Drive, Suite 875, Miami, Fla. 33133, 1-800-233-2305, “www. stabident.com” Stabident is a local anesthesia system for intraosseous injection. The Stabident system is made up of a perforator (a special form of drill, approximately 27-gauge, that is handpiece-driven) and a matching injection needle. The Alternative Stabident system has an additional guide sleeve that is placed in the hole made by the perforator to guide the injection needle. These injection systems perforate the cortical plate so that local anesthetic may be injected into the cancellous bone. INDICATIONS AND CONTRAINDICATIONS FOR USE
dMaximum dosage is one cartridge per visit. Inject slowly and gently. dIf a local anesthetic solution that contains epinephrine is used, it is essential to inject it very slowly while the patient is in a supine position. A rapid injection of a solution containing epinephrine could result in palpitations and a feeling of faintness. dThe amount of local anesthetic required to produce anesthesia using the Stabident System is much less
ACCEPTED
“Stabident or Alternative Stabident is Accepted as an effective intraosseous injection device for providing pulpal anesthesia when used on its own or as a supplement to inferior alveolar nerve block. In cases of irreversible pulpitis, it is effective as a supplement to inferior alveolar nerve block.”—Council on Scientific Affairs, American Dental Association
than that required in infiltration and regional block methods. dPulpal anesthesia lasts 15 to 30 minutes. SAFETY AND EFFICACY DATA Published clinical studies have evaluated pulpal anesthesia achieved by intraosseous, or IO, injection with the Stabident system. These randomized, controlled clinical trials were conducted at The Ohio State University and enrolled between 38 and 51 patients. The Stabident IO injection was evaluated as a primary and as a supplemental injection. Guglielmo and colleagues1 found that IO injection of 1.8 milliliters of 2 percent lidocaine with 1:100,000 epinephrine or 2 percent mepivacaine with 1:20,000 levonordefrin, used to supplement an inferior alveolar nerve, or IAN, block, significantly increased anesthetic success in first molars and second premolars. Nusstein and colleagues2 found that a supplemental mandibular IO injection of 1.8 mL of 2 percent lidocaine with 1:100,000 epinephrine was 90 percent successful in gaining total pulpal anesthesia for teeth diagnosed with irreversible pulpitis. Gallatin and colleagues3 found that IO injection of 1.8 mL of 3 percent mepivacaine, when used to augment an IAN block, significantly increased anesthetic success for 30 minutes in the first molar. Reitz and colleagues4 found that supplemental IO injection of 0.9 mL of 2 percent lidocaine with 1:100,000 epinephrine distal to the second premolar significantly increased the success of pulpal anesthesia in the second premolar (for 50 minutes) and first molar (for 20 minutes) compared with the IAN block alone. Reisman and colleagues5 found that supplemental IO injection of 3 percent mepivacaine for mandibular posterior teeth with irreversible pulpitis resulted in anesthetic success of 80 percent compared with the 25 percent success of IAN block alone. Dunbar and colleagues6 reported that for mandibular first molars, an IO supplemental injection to an IAN block increased anesthetic success from 42 percent to 90 percent, and decreased the percentage of anesthetic failure from 32 percent with IAN alone to 0 percent with IAN plus IO. Coggins and colleagues7 found that IO injection alone provided pulpal anesthesia in 75 percent to 93 percent of noninflamed maxillary and mandibular teeth. OTHER APPROVALS AND CERTIFICATIONS Stabident and Alternative Stabident have received U.S. Food and Drug Administration Premarket Notification
The Dental Product Spotlight appears in JADA each month to help dentists stay current on new products entering the marketplace and receiving the ADA Seal of Acceptance. These reports are prepared by the ADA Division of Science, in cooperation with The Journal of the American Dental Association. All rights reserved.
982
JADA, Vol. 133, July 2002 Copyright ©2002 American Dental Association. All rights reserved.
DENTAL P R O D U C T
(510[k]) and the CE mark. (The CE mark is the official marking required by the European Community for all electric and electronic equipment that will be sold or put into service for the first time anywhere in the European Community. It proves to the buyer, or user, that the product fulfills all essential safety and environmental requirements as they are defined in the socalled European Directives. CE marked products are presumed to conform with the requirements of Directives and as such can be supplied anywhere in the European Community without further testing.) 1. Guglielmo A, Reader A, Nist R, Beck M, Weaver J. Anesthetic efficacy and heart rate effects of the supplemental intraosseous injection of 2 percent mepivacaine with 1:20,000 levonordefrin. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1999;87:284-93.
Intraosseous injection Successful anesthesia during dental procedures can be difficult to achieve. Intraosseous injection has been shown to enhance anesthetic success significantly when used alone1-3 or as a supplement to conventional local anesthetic, particularly in cases of irreversible pulpitis.4-9 Anesthesia of the surrounding soft tissue, bone and teeth is achieved by the deposition of local anesthetic into the vascular spaces of the alveolar cancellous bone. EFFICACY When used alone, intraosseous injection of 1.8 milliliters 2 percent lidocaine with 1:100,000 epinephrine was shown to be 90 percent effective for anesthetizing maxillary molars and 75 percent effective for mandibular molars.2,9,10 As a supplemental injection, intraosseous deposition of 2 percent lidocaine with 1:100,000 epinephrine was 90 percent effective.8 Lip numbness reportedly is attenuated with intraosseous injection10 and tongue and cheek numbness reportedly do not occur.3 The onset of anesthesia is immediate, and the duration is from 15 to 30 minutes, depending on the presence of vasoconstrictors.2,10 All the clinical studies that evaluated the efficacy of intraosseous injections used the Stabident system.1-18 CARDIOVASCULAR EFFECTS Intraosseous injection of local anesthetic solutions containing vasoconstrictors (2 percent lidocaine with 1:100,000 epinephrine) caused a transient increase in heart rate in a majority of patients, but had no effect on blood pressure.1,4 The average increase was about 25 beats per minute and occurred during solution deposi-
SPOTLIGHT
2. Nusstein J, Reader A, Nist R, Beck M, Meyers WJ. Anesthetic efficacy of the supplemental intraosseous injection of 2 percent lidocaine with 1:100,000 epinephrine in irreversible pulpitis. J Endod 1998;24:487-91. 3. Gallatin E, Stabile P, Reader A, Nist R, Beck M. Anesthetic efficacy and heart rate effects of the intraosseous injection of 3 percent mepivacaine after an inferior alveolar nerve block. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2000;89:83-7. 4. Reitz J, Reader A, Nist R, Beck M, Meyers WJ. Anesthetic efficacy of a repeated intraosseous infection given 30 min. following an inferior alveolar nerve block/intraosseous injection. Anesth Prog 1998;45:143-9. 5. Reisman D, Reader A, Nist R, Beck M, Weaver J. Anesthetic efficacy of the supplemental intraosseous injection of 3 percent mepivacaine in irreversible pulpitis. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997;84:676-82. 6. Dunbar D, Reader A, Nist R, Beck M, Meyers W. Anesthetic efficacy of the intraosseous injection after an inferior alveolar nerve block. J Endod 1996;22:481-6. 7. Coggins R, Reader A, Nist R, Beck M, Meyers WJ. Anesthetic efficacy of the intraosseous injection in maxillary and mandibular teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1996;81:634-41.
tion or within two minutes after solution deposition. The heart rate returned to normal within four minutes. The authors stated that this effect would not be clinically significant in most patients, but patients should be informed of the possible increase in heart rate to lessen their anxiety. In patients whose medical condition or therapeutic regimens contraindicate the use of epinephrine- or levonordefrin-containing solutions, mepivacaine can be used as an alternative anesthetic.1,4 INDICATIONS Primary intraosseous injections are useful for short procedures and for lessening the feeling of numbness.9 However, intraosseous injections are most useful for enhancing the efficacy and duration of anesthesia achieved by conventional methods, particularly in refractory cases.9 CONTRAINDICATIONS Intraosseous injections may be contraindicated in patients with severe periodontal disease or acute infection, a narrow zone of attached gingiva and crowded teeth.9,11 INFECTION No studies have evaluated the effect of intraosseous injection on gingiva and bone, but Dunbar and colleagues8 have found no incidence of infection after these injections. Coggins and colleagues10 found that 1.25 percent of the subjects (two of 160) required antibiotic administration owing to swelling and purulence at the injection site. Within 14 days, the sites had healed. MARKETED DEVICES There are three devices marketed for intraosseous injection: the Stabident System (see Dental Product Spotlight), Hypo Brand Intraosseous Needle (MPL Technologies, Franklin Park, Ill., “www.dentsply.com/ divisions/mpl.html”) and The IntraFlow Dental Anes-
JADA, Vol. 133, July 2002 Copyright ©2002 American Dental Association. All rights reserved.
983