Abstract
There is a growing body of work examining whether a palatal injection is necessary for the extraction of maxillary teeth with contemporary local anaesthetics. The available literature was reviewed systematically by conducting a search of the PubMed, EMBASE, and Cochrane CENTRAL databases for trials examining outcomes of maxillary tooth extraction where buccal injection of local anaesthetic only was used for one or more test groups. The selected studies were reviewed for study type, sample size, quality, participant characteristics and methodology, outcome variables, and findings. Fifteen studies met the inclusion criteria. Six of the studies were randomized controlled trials. Four studies were controlled clinical trials that did not report randomization. Five were clinical trials that were not controlled and examined outcomes of one or more test groups. The pain of local anaesthetic injection(s) in the test group (buccal injection only) versus control group (buccal and palatal injection), number of cases requiring supplemental buccal or palatal injection in cases of unsuccessful local anaesthesia, and pain during the procedure were designated as primary outcomes. Pain on probing of the mucosa was designated as a secondary outcome. All nine controlled studies that assessed pain during the procedure found no statistically significant difference between the test and control groups.
Palatal injection (infiltration and/or block) is widely practiced for the removal of maxillary teeth under local anaesthesia, although it is poorly tolerated by patients due to the rich nerve supply of the palatal tissues and firm attachment of palatal mucosa to bone. A number of techniques are used in clinical practice to reduce the discomfort of palatal injection, including pressure applied to the area of needle penetration, a fine gauge needle, conventional topical anaesthetics, eutectic mixture of local anaesthetic (EMLA) cream, topical cooling of the palate (e.g. topical ice), computerized delivery systems, and transcutaneous electronic nerve stimulation (TENS). However, the necessity of palatal injection for maxillary tooth extractions has been questioned by a number of authors. The purpose of this study was to systematically review all available trials examining outcomes of maxillary tooth extractions using buccal injection of local anaesthetic only.
Methods
Trials that examined any outcome of the extraction of maxillary teeth (anterior and/or premolar and/or molar), where one or more test groups used buccal injection of local anaesthetic only, were reviewed. In selecting the studies for review, no restrictions were imposed on study participants, e.g. health status and age. A test group was defined as a group of participants initially given a buccal injection of local anaesthetic only. A control group was defined as a group of participants initially given both a buccal and palatal injection of local anaesthetic. This was regardless of the protocol that the trial used for cases of unsuccessful anaesthesia; some trials gave a supplemental palatal injection in the test and/or control group if there was unsuccessful anaesthesia.
The search ( Fig. 1 ) was designed by the first author. If used the PubMed (from 1951 through June 2015), EMBASE (from 1966 through June 2015), and Cochrane Central Register of Controlled Trials (CENTRAL; from 1996 through June 2015) databases. The medical subject headings and key words used in the search are presented in the Appendix. There were no language restrictions and non-English articles were translated.
All studies generated by the search were reviewed independently in an un-blinded manner by both researchers (EBJ, TL). The titles and abstracts were reviewed, followed by the full-text of those deemed potentially relevant, to assess the eligibility of the study for inclusion according to the pre-defined criteria. A manual search of the reference lists of studies identified as potentially relevant in the database search was conducted. Full-text articles were available for all studies included. Disagreements between the two reviewers were resolved by discussion.
The same reviewers independently assessed the risk of bias of included studies according to the Cochrane Handbook for Systematic Reviews of Interventions criteria, and disagreements were again resolved by discussion. As per the Cochrane Handbook, a study was designated as a randomized controlled trial only if the methods of random sequence generation were clearly described and were considered to be adequate.
The first author independently extracted data from those studies meeting the inclusion criteria using a standardized data extraction form. The selected studies were reviewed for study type, sample size, quality, participant characteristics and methodology, outcome variables, and findings. When required, investigators were contacted for clarification of information or if data were missing.
Results
The search identified 416 studies. Thirty-five studies were potentially eligible on the basis of title and abstract. 15 studies met the inclusion criteria; these were published from 2006 through 2015 ( Fig. 1 ). One study was not in English and it was translated.
Characteristics of studies included
The sample size of the studies ranged from 30 to 200 participants. Six studies utilized a parallel design, six studies utilized a split-mouth design, two studies utilized a combination of split-mouth and parallel designs, and one study utilized a single test group only. Six of the studies were randomized controlled trials. Four studies were controlled clinical trials that did not report randomization. Five were clinical trials that were not controlled, of which four examined outcomes of two or more test groups with different protocols. All 10 controlled trials compared the test group (buccal injection of local anaesthetic only) with a positive control (standard practice, buccal and palatal injection of local anaesthetic). One study included a placebo (saline) palatal injection in the test group, while the others administered a buccal injection of local anaesthetic only in the test group.
Results
The search identified 416 studies. Thirty-five studies were potentially eligible on the basis of title and abstract. 15 studies met the inclusion criteria; these were published from 2006 through 2015 ( Fig. 1 ). One study was not in English and it was translated.
Characteristics of studies included
The sample size of the studies ranged from 30 to 200 participants. Six studies utilized a parallel design, six studies utilized a split-mouth design, two studies utilized a combination of split-mouth and parallel designs, and one study utilized a single test group only. Six of the studies were randomized controlled trials. Four studies were controlled clinical trials that did not report randomization. Five were clinical trials that were not controlled, of which four examined outcomes of two or more test groups with different protocols. All 10 controlled trials compared the test group (buccal injection of local anaesthetic only) with a positive control (standard practice, buccal and palatal injection of local anaesthetic). One study included a placebo (saline) palatal injection in the test group, while the others administered a buccal injection of local anaesthetic only in the test group.
Risk of bias
Figs. 2 and 3 display the risk of bias within each study and across the studies, according to each of the Cochrane Handbook criteria. Because important information was often missing from the methods sections of the studies, the risk of bias was frequently unclear. Sequence generation, allocation concealment, and blinding (particularly who was blinded) were frequently unreported. Requests for clarification of methods and results were sent to 14 investigators and seven provided an informative response. None of the studies reported whether the investigators had any conflicts of interest. Sample sizes were often small, which is a risk for bias.
Methodology and participant characteristics
There was substantial variation in trial protocols, particularly with regard to the local anaesthetic (and volume) used, how the study design accommodated for patients whose initial anaesthesia was unsuccessful (i.e. did not accommodate, use of supplemental buccal injection and/or supplemental palatal injection), the time interval between administering local anaesthetic, supplemental anaesthetic, and initiation of the procedure, as well as the teeth extracted (region of the maxilla: anterior and/or premolar and/or molar). For this reason, the results for each outcome variable could not be meta-analysed. Table 1 summarizes major characteristics of the studies and the patient populations. The populations were similar with respect to age and health status.
| Study | Year | Country | Design | Participants ( n ) | Sex ( n ) | Participants (health status) | Protocol | Extraction technique/time between LA and extraction | Age range (years) | Age (mean (SD) or median) (years) | Impaction status/teeth a |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Luqman et al. | 2015 | Pakistan | Parallel | 194 | F: 113 M: 81 |
Healthy | Test: 1.7 ml of 4% AH + 1:200,000 AD via BI; if required, SPI 0.2–0.4 ml of same LA repeated until anaesthesia Control: 1.0 ml of 2% LH + 1:100,000 AD via BI and 0.2–0.4 ml via PI; if required, SPI 0.2–0.4 ml of same LA repeated until anaesthesia |
Elevators or forceps/depending on time to anaesthesia on probing of palatal mucosa | 20–60 | Mean: 41.1 (13.6) |
Erupted/Mx |
| Kumaresan et al. | 2015 | Malaysia | Parallel | 150 | F: 83 M: 67 |
Healthy | Test: 1.5 ml 2% LH + 1:80,000 AD via BI; if required, SPI 0.3 ml of same LA Control: 1.5 ml 2% LH + 1:80,000 AD via BI + 0.3 ml via PI |
Non-surgical/depending on time to anaesthesia on probing of palatal mucosa | 15–50 | Median: 35.9 | Erupted/A, P, M1, M2 |
| Darawade et al. | 2014 | India | Split-mouth | 50 | NR | Healthy | Test 1: 0.5–1.0 ml of 4% AH + 1:100,000 AD via BI; if required, SPI 0.5 ml of same LA Test 2: 0.8–1.0 ml of 2% LH + 1:100,000 AD via BI; if required, SPI 0.5 ml of same LA |
Forceps/time NR | 15–25 | NR | Erupted/P |
| Sharma et al. | 2014 | India | Split-mouth | 80 | F: 43 M: 37 |
Healthy | Test 1: 1.8 ml 2% LH + 1:100,000 AD via BI; if required, SPI (volume NR) of same LA Test 2: 0.9 ml 4% AH + 1:100,000 AD via BI; if required, SPI (volume NR) of same LA |
NR/6 min (TG1/TG2) | 18–67 | Mean: 38.7 (12.7) | Erupted P/M |
| Lima et al. | 2013 | Brazil | Parallel | 30 | NR | NR | Test 1: 1.8 ml 4% AH + 1:100,000 AD via BI Test 2: 1.8 ml 4% AH + 1:200,000 AD via BI |
Surgical (mucoperiosteal flap, tooth elevation, sutures)/5 min (TG1/TG2) | 15–46 | NR | Partially impacted/M3 |
| Somuri et al. | 2013 | India | Split-mouth | 30 | F: 19 M: 11 |
No severe systemic disease | Test: 1.7 ml 4% AH + 1:100,000 AD via BI Control: 1.75 ml 2% LH + 1:100,000 AD via BI + 0.25 ml via PI |
Forceps/time NR | 10–30 | Mean: 17.73 (4.30) | Erupted/P |
| Yadav et al. | 2013 | India | Parallel | 200 | F: 79 M: 121 |
No severe systemic disease | Test: 2.0 ml 2% LH + 1:200,000 AD via BI Control: 1.75 ml 2% LH + 1:200,000 AD via BI and 0.25 ml via PI |
Elevation + forceps/5 min (TG/CG) | NR | Mean Test: 35.2 (NR) Control NR (NR) |
Erupted/M3 |
| Isik et al. | 2011 | Turkey | NA | 45 | NR | NR | Test: 1.7 ml 4% AH + 1:100,000 AD via BI; if required, SPI 0.3 ml of same LA | Non-surgical/6 min | 15–76 | NR | Erupted/A, P, M1, M2 |
| Sekhar et al. | 2011 | India | Parallel | 100 | F: 63 M: 37 |
No severe systemic disease | Test: 2.0 ml 2% LH + 1:80,000 AD via BI Control: 1.75 ml 2% LH + 1:80,000 AD via BI + 0.25 ml via PI |
Elevation + forceps/8 min (TG/CG) | NR | Mean Test: 40.21 (13.86) Control: 36.40 (11.86) |
Erupted/Mx |
| Fan et al. | 2009 | China | Split-mouth | 71 | F: 33 M: 38 |
No severe systemic disease | Test: 1.7 ml of 4% AH + 1:100,000 AD via BI; if required, SBI 1.7 ml of same LA; if required, SPI 0.4 ml of same LA Control: 1.7 ml of 4% AH + 1:100,000 AD via BI + 0.4 ml via PI; if required, SBI 1.7 ml of same LA; if required, SPI 0.4 ml of same LA |
Elevator or forceps/5 min (TG/CG) | 18–67 | Mean: 25.37 (NR) | Erupted/Mx |
| Lima-Júnior et al. | 2009 | Brazil | Split-mouth | 100 | NR | NR | Test 1A: 1.8 ml 4% AH + 1:100,000 AD via BI; if required, SPI 0.6 ml of same LA Test 1B: 1.8 ml 4% AH + 1:100,000 AD via BI; if required, SPI 0.6 ml of same LA Test 2A: 1.8 ml 4% AH + 1:200,000 AD via BI; if required, SPI 0.6 ml of same LA Test 2B: 1.8 ml 4% AH + 1:200,000 AD via BI; if required, SPI 0.6 ml of same LA |
Surgical (incision, extraction, suture)/5 min (TG1A, TG2A), 10 min (TG1B, TG2B) | 15–46 | NR | Impacted/M3 |
| Lassemi et al. | 2008 | Iran | Parallel | 60 | Test: F: 16 M: 14 Control: (NR) |
NR | Test: 1.8 ml of LH + 1:80,000 AD via BI; if required, SPI (volume NR) Control: LH + 1:80,000 AD via BI (volume NR) + via PI (volume NR) |
NR/time NR | NR | Mean Test: 44.2 (NR) Control: (NR) |
Erupted/I |
| Peng et al. | 2008 | China | Split mouth + parallel | 104 | F: 49 M: 55 |
Healthy | Test: 1.7 ml of 4% AH + 1:100,000 AD via BI Control: 1.7 ml of 4% AH + 1:100,000 AD via BI + 0.25 ml of 2% LH (vasoconstrictor NR) via PI |
NR/5 min | 18–56 | Mean: 42.4 (NR) | Erupted/Mx |
| Badcock et al. | 2007 | Australia | Split-mouth | 51 | F: 34 M: 17 |
NR | Test: 2.2 ml 2% LH + 1:80,000 AD via BI + 0.2 ml normal saline via PI; if required, SBI 2.2 ml of same LA; if required, SPI 0.2 ml of same LA Control: 2.2 ml 2% LH + 1:80,000 AD via BI + 0.2 ml 2% LH (without vasoconstrictor) via PI; if required, SBI 2.2 ml of same LA as BI; if required, SPI 0.2 ml of same LA as BI |
Non-surgical + surgical (mucoperiosteal flap ± bone removal, no suture)/5 min (TG/CG) | 18–64 | Median: 24 | M3 (erupted, partially erupted, and unerupted) |
| Uckan et al. | 2006 | Turkey | Split mouth + parallel | 53 | F: 25 M: 28 |
No severe systemic disease | Test: 2.0 ml of 4% AH + 1:100,000 AD via BI Control: 1.75 ml of 4% AH + 1:100,000 AD via BI + 0.25 ml via PI |
NR/5 min (TG/CG) | 18–48 + 4 children | Mean (adult): 41.54 (NR) Mean (child): 10.5 (NR) |
Erupted/Mx |
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