CONSORT Clinical Trial
Anesthetic Efficacy of 1.8 mL and 3.6 mL of 2% Lidocaine with 1:100,000 Epinephrine for Maxillary Infiltrations Alan Mikesell, DDS, MS,* Melissa Drum, DDS, MS,† Al Reader, DDS, MS,† and Mike Beck, DDS, MA‡ Abstract The purpose of this prospective, randomized, singleblinded study was to measure the degree of anesthesia obtained with 1.8 mL and 3.6 mL of 2% lidocaine with 1:100,000 epinephrine in maxillary infiltrations. Ninetysix adult subjects randomly received infiltrations of 1.8 mL and 3.6 mL of the lidocaine solution at two separate appointments, in a crossover design. Thirty-two lateral incisors, 32 first premolars and 32 first molars were studied in this investigation. Anesthetic success (obtaining two consecutive 80 readings with the electric pulp tester) for the two volumes ranged from 97% to 100%. The onset of pulpal anesthesia was not statistically different between the two volumes. For both volumes, the lateral incisors had a higher percentage of anesthesia of short duration than the first premolar and first molar. The 3.6 mL volume provided a statistically longer duration of pulpal anesthesia for the lateral incisor, first premolar, and first molar. (J Endod 2008; 34:121–125)
Key Words Infiltration, lidocaine, maxillary
From *Private Practice; Wapakoneta, Ohio; and Sections of †Endodontics and ‡Oral Biology, The Ohio State University, Columbus, Ohio. Address requests for reprints to Dr Melissa Drum, Department of Endodontics, College of Dentistry, The Ohio State University, 305 W 12th Ave, Columbus, OH 43210. E-mail address:
[email protected]. 0099-2399/$0 - see front matter Copyright © 2008 by the American Association of Endodontists. doi:10.1016/j.joen.2007.11.001
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axillary anesthesia is more successful than mandibular anesthesia (1, 2). Nusstein et al. (1) found anesthetic failure (no 2 consecutive 80 readings with an electric pulp tester) occurred from 10% to 39% of the time after an inferior alveolar nerve block. Malamed (2) states that 95% of maxillary infiltration injections (supraperiosteal or field blocks) produce successful anesthesia. Previous studies (3–17) have evaluated the success of maxillary infiltrations using the electric pulp tester. When using a volume of 1.8 mL or less, pulpal anesthetic success (obtaining maximum output with an electric pulp tester) ranged from 64% to 100%. The duration of pulpal anesthesia with a lidocaine solution varied from 31 minutes to 100 minutes, with the majority of studies showing duration times of less than 60 minutes (3–16). Because the duration is less than 60 minutes, it would be worthwhile to study the effects of increasing the volume of anesthetic solution to prolong duration. Additionally, only a few studies have evaluated infiltration injections in the posterior maxilla (10 –11, 14 –16). Because anesthesia may vary between the anterior and posterior maxilla, it would be of interest to study posterior infiltration anesthesia. The purpose of this prospective, randomized, single-blinded study was to measure the degree of anesthesia obtained with 1.8 mL and 3.6 mL of 2% lidocaine with 1:100,000 epinephrine in maxillary infiltrations.
Materials and Methods Ninety-six adult subjects participated in this study. The subjects were in good health and were not taking any medications that would alter pain perception. Exclusion criteria were as follows: younger than 18 or older than 60 years of age, allergies to local anesthetics or sulfites, pregnant females, a history of significant medical conditions, taking any medications that may affect anesthetic assessment, active sites of pathosis in area of injection, and inability to give informed consent. The Ohio State University Human Subjects Review Committee approved the study, and written consent was obtained from each subject. By using a crossover design, 32 subjects received 2 maxillary lateral incisor infiltrations, 32 subjects received 2 maxillary first premolar infiltrations, and 32 subjects received 2 maxillary first molar infiltrations at 2 separate appointments spaced at least 1 week apart. For each lateral incisor, first premolar, and first molar, the two injections consisted of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine and 3.6 mL of 2% lidocaine with 1:100,000 epinephrine. One author administered all injections (AM). By using the crossover design, 64 infiltrations were administered for the lateral incisor, 64 infiltrations for the first premolar, and 64 infiltrations for the first molar. Each subject served as his/her own control. Seventeen left and 15 right lateral incisors were used. Sixteen left and 16 right first premolars were used. Seventeen left and 15 right maxillary first molars were used. The side randomly chosen for the first infiltration was used again for the second infiltration. The same tooth was used at both visits for each anesthetic volume. The contralateral maxillary canine was used as the unanesthetized control for the premolars and molars, and the contralateral maxillary premolar was used for the lateral incisors to ensure that the pulp tester was operating properly and that the subject was responding appropriately. A visual and clinical examination was conducted to ensure that all teeth were free of caries, large restorations, crowns, and periodontal disease and that none had a history of trauma or sensitivity. At each appointment and before injection, the experimental control teeth were tested three times with the electric pulp tester (Analytic Technology Corp, Redmond,
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CONSORT Clinical Trial TABLE 1. Discomfort Ratings of Solution Deposition Discomfort ratings Tooth Lateral incisor* 1.8 mL 3.6 mL First premolar* 1.8 mL 3.6 mL First molar* 1.8 mL 3.6 mL
None (0) (%)
Mild (1) (%)
Moderate (2) (%)
Severe (3) (%)
Mean
7 (22) 6 (19)
13 (41) 17 (53)
11 (34) 9 (28)
1 (3) 0 (0)
1.2 1.1
14 (44) 10 (31)
15 (47) 15 (47)
3 (9) 6 (19)
0 (0) 1 (3)
0.66 0.97
9 (28) 14 (44)
21 (66) 14 (44)
2 (6) 4 (12)
0 (0) 0 (0)
0.79 0.67
*There were no significant differences between the solution volumes (p ⬎ 0.05).
WA) to obtain baseline vitality. The teeth were isolated with cotton rolls and dried with an air syringe. Toothpaste was applied to the probe tip, which was placed in the middle third of the facial or buccal surface of the tooth being tested. The current rate was set at 25 seconds to increase from no output (0) to the maximum output (80). The number at the initial sensation was recorded. Trained personnel, who were blinded to the anesthetic volumes, administered all preinjection and postinjection tests. Before the experiment, the two volumes of anesthetic solutions were randomly assigned four-digit numbers from a random number table. The random numbers were assigned to a subject to designate which anesthetic volume was to be administered at each appointment. The solutions were prepared, under sterile conditions, by adding either 1.8 mL or 3.6 mL of 2% lidocaine with 1:100,000 epinephrine (Xylocaine with Epinephrine; Astra Pharmaceutical Products, Inc, Westborough, MA), from standard anesthetic cartridges into a 5 mL Luer-Lok syringe (Becton, Dickinson, and Co, Rutherford, NJ). All anesthetic formulations were checked to ensure that the anesthetic solution had not expired. The random number was written on labels that were placed on the syringes. Only the random numbers were recorded on the datacollection sheets to further blind the experiment. A standard infiltration injection was administered with a 27 G 1-in needle (Monoject; Sherwood Medical, St Louis, MO) attached to the Luer-Lok syringe. The injections were centered over the lateral incisor apex, first premolar buccal root apex, or halfway between the mesialbuccal and distal-buccal roots of the first molar. The needle was inserted into the alveolar mucosa with the bevel facing the periosteum. Once the periosteum was reached, the needle was withdrawn 1 mm. After negative aspiration, the anesthetic solution was deposited over a 3-minute time period for both volumes (1.8 mL or 3.6 mL) (ie, the 1.8 mL volume was injected at a rate of 0.6 mL/min, and the 3.6 mL volume was injected at a rate of 1.2 mL/min as timed with a stopwatch). Each subject rated the discomfort of solution deposition using the following scale: 0, no pain; 1, mild pain (pain that was recognizable but not discomforting); 2, moderate pain (pain that was discomforting but bearable); and 3, severe pain (pain that caused considerable discomfort and was difficult to bear). At 1 minute after injection, the experimental test tooth (depending on which tooth group was being evaluated) and the contralateral control tooth were pulp tested. At 3 minutes, the test tooth was again pulp tested. This cycle of testing was repeated every 3 minutes. At every third cycle, the control tooth was tested by an inactivated electric pulp tester to test the reliability of the subject (ie, if the subject responded positively to an inactivated pulp tester, then they were not reliable and could not be used in the study). All testing was stopped at 60 minutes after injection. Pulpal anesthesia was defined as no subject response to the pulp tester at an 80 reading (maximum output). Experimentally, the 80 read122
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ing is an endpoint that can be used to measure complete pulpal anesthesia over time. This allows comparisons of anesthetic solution volumes without the clinical variations of depth of cavity preparation, tooth location, or procedure. The time for the onset of pulpal anesthesia was recorded at the first of 2 consecutive 80 readings. Anesthesia was considered successful if 2 consecutive 80 readings were recorded. Anesthesia was noncontinuous if the subject achieved 2 consecutive 80 readings, lost the 80 reading, and then regained the 80 reading during the 60 minutes. Anesthesia was of short duration if the subject achieved 2 consecutive 80 readings, lost the 80 reading, and never regained it within the 60-minute period. Onset times, anesthetic success, incidence of pulpal anesthesia, noncontinuous anesthesia, short duration of anesthesia, and incidence of pulpal anesthesia were analyzed nonparametrically by using multiple McNemar tests. Pain of solution deposition was analyzed by using a one-way repeated measures analysis of variance. Comparisons were considered significant at p ⬍ 0.05.
Results Ninety-six adult subjects, 74 men and 22 women, ranging in age from 21 to 43 years with an average age of 26 years participated in the study. Discomfort ratings for solution deposition are shown in Table 1. There was no statistically significant difference between the two anesthetic volumes. The onset of pulpal anesthesia is shown in Table 2. There was no statistically significant difference between the two anesthetic volumes. All subjects reported lip or cheek numbness with both volumes. Anesthetic success is presented in Table 3. The success rates ranged from 97% to 100% for the two anesthetic volumes. There was no statistically significant difference between the two anesthetic volumes. Noncontinuous anesthesia is presented in Table 3. The 3.6 mL volume significantly decreased the incidence of noncontinuous anesthesia in the first molar. Anesthesia of short duration is also presented in Table 3. The 3.6 mL volume significantly decreased anesthesia of short duration for the lateral incisors, first premolars, and first molars. Figures 1 through 3 show the incidence of anesthesia for the 1.8 mL and 3.6 mL volumes. Significantly improved pulpal anesthesia was TABLE 2. The Onset of Pulpal Anesthesia (minutes ⫾ standard deviation)
Lateral incisor* First premolar* First molar*
1.8 mL volume
3.6 mL volume
p value
2.87 ⫾ 0.35 2.25 ⫾ 0.42 4.68 ⫾ 0.97
2.81 ⫾ 0.38 1.50 ⫾ 0.24 2.48 ⫾ 0.05
0.16 0.06 0.07
*There was no significant difference (p ⬎ 0.05) between the solutions.
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CONSORT Clinical Trial TABLE 3. Anesthetic Success, Noncontinuous Anesthesia, and Anesthesia of Short Duration (percentage and number) Tooth Anesthetic success Lateral incisor First premolar First molar Noncontinuous anesthesia Lateral incisor First premolar First molar Anesthesia of short duration Lateral incisor First premolar First molar
1.8 mL volume
3.6 mL volume
p value
97% (31/32) 100% (32/32) 100% (32/32)
97% (31/32) 100% (32/32) 97% (31/32)
1.00 1.00 1.00
3% (1/32) 16% (5/32) 22% (7/32)
3% (1/32) 3% (1/32) 0% (0/32)
1.00 0.22 0.03*
72% (23/32) 42% (15/32) 50% (16/32)
44% (14/32) 19% (6/32) 9% (3/32)
0.040* 0.003* 0.002*
*There was a significant difference between the solution volumes (p ⬍ 0.05).
shown from minute 21 to minute 59 for the lateral incisor (Fig. 1). Statistically improved pulpal anesthesia was shown at minute 49 to minute 59 for the first premolar (Fig. 2) and from minute 49 through minute 59 for the first molar (Fig. 3).
Discussion We based our use of the pulp test reading of 80 (signaling maximum output) as a criterion for pulpal anesthesia on the studies of Dreven et al. (18) and Certosimo and Archer (19). These studies showed that no patient response to an 80 reading ensured pulpal anesthesia in vital asymptomatic teeth. Additionally, Certosimo and Archer (19) showed that electric pulp test readings of less than 80 resulted in pain during operative procedures in asymptomatic teeth. Therefore, using the electric pulp tester before beginning dental procedures on asymptomatic vital teeth will provide the clinician a reliable indicator of pulpal anesthesia. All subjects felt profound lip or cheek numbness, but pulp testing revealed that they did not always have pulpal anesthesia for the 60 minutes (Figs. 1–3). Asking the patient if the lip or cheek is numb only indicates soft-tissue anesthesia; it does not guarantee successful pulpal anesthesia. There was no statistically significant difference in discomfort ratings for solution deposition between the two anesthetic volumes (Table 1). There was a higher incidence of moderate pain in the lateral incisor with both volumes. However, the mean pain ratings for all teeth were in the mild range for both solutions (Table 1). No other maxillary study
Percentage of 80 Readings
***
100 **
**
75
*
*** **
50 3.6 mL Volume
25
1.8 mL Volume
Percentage of 80 Readings
* **** * *
100
has rated the pain of solution deposition for 1.8 and 3.6 mL volumes of a lidocaine solution. Therefore, no comparisons are possible. Basically, depositing a 3.6 mL volume of a lidocaine solution, as was done in this study, does not statistically cause more pain. For all three teeth, the difference in the onset of pulpal anesthesia was not significantly different between the two lidocaine volumes (Table 2). Previous authors (4 –16) have reported onset times of 2 to 5 minutes for maxillary infiltrations using lidocaine solutions. Waiting 3 minutes for the lateral incisor and first premolar should ensure pulpal anesthesia. The first molar may require an approximately 5-minute wait time if 1.8 mL of 2% lidocaine with 1:100,000 epinephrine is used. Using the electric pulp tester or EndoIce (Hygenic Corp, Akron, OH) before beginning dental procedures on asymptomatic vital teeth will provide the clinician a reliable indicator of the onset of pulpal anesthesia (18 –20). The success of the infiltration of both lidocaine volumes ranged from 97% to 100% (Table 3). Various authors (3–17) have evaluated the success of maxillary infiltrations using the electric pulp tester. Generally, the results of these studies showed successful anesthesia ranging from 64% to 100%. It is very difficult to compare the results of the previous studies to the current study because the authors used different dosages of anesthetic agents and vasoconstrictors and evaluated different teeth. Gross et al. (16) and Nusstein et al. (3) used a similar methodology to the current study and showed a 97% and an 85% success rate (obtaining 2 consecutive 80 readings) for the lateral incisor, respectively, with an infiltration of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. Gross et al. (16) showed an 82% success rate for the first
*
** * * *
75 50 1.8 mL Volume
3.6 mL Volume
25 0
0 1
7
13
19
25
31
37
43
49
55
Time (Minutes)
Figure 1. The incidence of maxillary lateral incisor pulpal anesthesia as determined by the lack of response to electrical pulp testing at the maximum setting (percentage of 80 readings) at each postinjection time interval for the two lidocaine volumes. Significant differences are marked with an asterisk.
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1
7
13
19
25
31
37
43
49
55
Time (Minutes)
Figure 2. The incidence of maxillary first premolar pulpal anesthesia as determined by the lack of response to electrical pulp testing at the maximum setting (percentage of 80 readings) at each postinjection time interval for the two lidocaine volumes. Significant differences are marked with an asterisk.
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CONSORT Clinical Trial Percentage of 80 Readings
100
* ** * *
*
75 50 1.8 mL Volume
3.6 mL Volume
25 0 1
7
13
19
25
31
37
43
49
55
Time (Minutes)
Figure 3. The incidence of maxillary first molar pulpal anesthesia as determined by the lack of response to electrical pulp testing at the maximum setting (percentage of 80 readings) at each postinjection time interval for the two lidocaine volumes. Significant differences are marked with an asterisk.
molar with an infiltration of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. In general, the infiltration injection of 1.8 mL of 2% lidocaine with 1:100,000 epinephrine may not always be 100% successful because of the individual variations in response to the drug administered and variations of anatomy as well as tooth position. Because we studied a young adult population, the results of this study may not apply to children or the elderly. Using 1.8 mL of the lidocaine solution, anesthesia of short duration occurred 72% of the time in the lateral incisor (Table 3). Figure 1 shows the decline of pulpal anesthesia over 60 minutes for the lateral incisor. Approximately 78% of the subjects had pulpal anesthesia at 30 minutes, 38% at 45 minutes, and 22% at 60 minutes (Fig. 1). Nusstein et al. (3) and Gross et al. (16) showed similar results using 1.8 mL of 2% lidocaine with 1:100,000 epinephrine. Anesthesia of short duration occurred from 42% to 50% of the time for the first premolar and first molar (Table 3). Figures 2 and 3 show a slower decline of pulpal anesthesia when compared with the lateral incisor. Approximately 94% and 91% of the subjects had pulpal anesthesia at 30 minutes, 75% and 78% at 45 minutes, and 50% and 47% at 60 minutes for the premolar and molar, respectively (Fig. 1). Therefore, the duration of pulpal anesthesia declines at a slower rate in the posterior teeth than in the lateral incisor. If an hour of pulpal anesthesia is required for the lateral incisor, first premolar, or first molar, 1.8 mL of 2% lidocaine with 1:100,000 epinephrine will not provide the necessary duration of pulpal anesthesia. The duration of pulpal anesthesia is a significant disadvantage to infiltration in the maxillary arch using 1.8 mL of 2% lidocaine with 1:100,000 epinephrine, and the duration is shorter in the lateral incisor than in posterior teeth. Using 3.6 mL of the lidocaine solution, anesthesia of short duration was significantly improved for all three teeth (Table 3). Figure 1 shows a statistically slower decline of pulpal anesthesia with the 3.6 mL volume over 60 minutes for the lateral incisor when compared with the 1.8 mL volume. Approximately 97% of the subjects had pulpal anesthesia at 30 minutes, 72% at 45 minutes, and 50% at 60 minutes (Fig. 1). Statistically improved pulpal anesthesia was shown from minute 21 to minute 59 (Fig. 1). However, 44% of the subjects still showed anesthesia of short duration (Table 3). Therefore, the duration of pulpal anesthesia remains problematic in the lateral incisor even though 3.6 mL of 2% lidocaine with 1:100,000 epinephrine was administered. In the premolars and first molars, anesthesia of short duration was reduced to 19% and 9%, respectively (Table 3). Approximately 97% of the subjects had pulpal anesthesia at 30 minutes, 91% at 45 minutes, and 78% and 84% 124
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at 60 minutes for the premolar and molar teeth, respectively (Figs. 2, 3). Statistically improved pulpal anesthesia was shown at minute 49 to minute 59 for the first premolar (Fig. 2) and from minute 49 through minute 59 for the first molar (Fig. 3). Therefore, anesthesia with the 3.6 mL volume shows a slower decline than a 1.8 mL volume and provides better pulpal anesthesia after about 49 minutes in posterior teeth (Figs. 2, 3). It is important to realize that even though pulpal anesthesia duration was prolonged with the 3.6 mL volume, if an hour of pulpal anesthesia is required for the lateral incisor, first premolar, or first molar, 3.6 mL of 2% lidocaine with 1:100,000 epinephrine may not provide the necessary duration of pulpal anesthesia. Pulp testing (EndoIce or electric pulp testing) the teeth will indicate if reinjection of the anesthetic solution is required (18 –20). Noncontinuous anesthesia (subjects going in and out of pulpal anesthesia) occurred from 3% to 22% of the time when using the 1.8 mL volume (Table 3). The use of the 3.6 mL volume reduced the incidence of noncontinuous anesthesia to 0% to 3% (Table 3). The result was significant for the first molar. Noncontinuous anesthesia may be related to the equilibrium established between the ionized and nonionized forms of the anesthetic solution resulting in inadequate pulpal anesthesia at some time periods. Administering 3.6 mL of a lidocaine solution will significantly decrease the occurrence of noncontinuous anesthesia in the first molar.
Conclusions We found the following: (1) depositing a 3.6 mL volume of a lidocaine solution was not significantly more painful than depositing a 1.8 mL volume using the same infiltration time for the lateral incisor, first premolar, and first molar; (2) the onset of pulpal anesthesia was not significantly different between 1.8 mL and 3.6 mL of the lidocaine solution for the lateral incisor, first premolar, and first molar; (3) anesthetic success for 1.8 mL and 3.6 mL of the lidocaine solution ranged from 97% to 100% for the lateral incisor, first premolar, and first molar; (4) anesthesia of short duration statistically occurred more often with the 1.8 mL volume of lidocaine for the lateral incisor, first premolar, and first molar; (5) for both volumes of lidocaine, the lateral incisors had a higher percentage of anesthesia of short duration than the first premolar and first molar; (6) the 3.6 mL volume of lidocaine provided a statistically longer duration of pulpal anesthesia than the 1.8 mL volume for the lateral incisor, first premolar, and first molar; and (7) noncontinuous anesthesia was statistically decreased for the first molar when the 3.6 mL volume of lidocaine was used.
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CONSORT Clinical Trial 9. Nordenram A, Danielsson K. Local anesthesia in elderly patients. An experimental study of oral infiltration anaesthesia. Swed Dent J 1990;14:19 –24. 10. Haas DA, Harper DG, Saso MA, Young ER. Lack of differential effect by Ultracaine (articaine) and Citanest (prilocaine) in infiltration anesthesia. J Can Dent Assoc 1991;57:217–23. 11. Haas DA, Harper DG, Saso MA, Young ER. Comparison of articaine and prilocaine anesthesia by infiltration in maxillary and mandibular arches. Anesth Prog 1990;37:230 –7. 12. Vahatalo K, Antila H, Lehtinen R. Articaine and lidocaine for maxillary infiltration anesthesia. Anesth Prog 1993;40:114 – 6. 13. Pitt Ford TR, Seare MA, McDonald F. Action of adrenaline on the effect of dental local anaesthetic solutions. Endod Dent Traumatol 1993;9:31–5. 14. Premdas CE, Pitt Ford TR. Effect of palatal injections on pulpal blood flow in premolars. Endod Dent Traumatol 1995;11:274 – 8. 15. Costa CG, Tortamano IP, Rocha RG, Francishone CE, Tortamano N. Onset and dura-
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tion periods of articaine and lidocaine on maxillary infiltration. Quintessence Int 2005;36:197–201. Gross R, McCartney M, Reader A, Beck M. A prospective, randomized, double-blind comparison of bupivacaine and lidocaine for maxillary infiltrations. J Endod 2007;33:1021– 4. Moore PA, Boynes SG, Hersh EV, et al. The anesthetic efficacy of 4 percent articaine 1:200,000 epinephrine: two controlled clinical trials. J Am Dent Assoc 2006;137: 1572– 81. Dreven L, Reader A, Beck M, Meyers W, Weaver J. An evaluation of the electric pulp tester as a measure of analgesia in human vital teeth. J Endod 1987;13:233– 8. Certosimo A, Archer R. A clinical evaluation of the electric pulp tester as an indicator of local anesthesia. Oper Dent 1996;21:25–30. Cohen HP, Cha BY, Spangberg LSW. Endodontic anesthesia in mandibular molars: a clinical study. J Endod 1993;19:370 –3.
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