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J Am Dent Assoc, Vol 137, No 1, 62-66.
© 2006 American Dental Association |  |
RESEARCH |
A clinical trial
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ABSTRACT |
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 TOP ABSTRACT SUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Methods. One hundred ninety-five patients with odontalgia, but without overt signs of infection, were enrolled in a prospective, double-blind, randomized clinical trial. Data included dental diagnosis, pain characteristics, presence of caries and restorations, presence and size of periapical radiolucencies and other diagnostic test results.
Results. Thirteen of 134 subjects for whom data were available had signs of infection at the follow-up visit. Subjects in the follow-up infected (FU-I) group had larger baseline radiolucencies than did subjects in the follow-up noninfected (FU-NI) group, and restorations were more prevalent for involved teeth in the FU-I group than in the FU-NI group.
Conclusions. A relationship exists between radiolucency size and the presence of amalgam restorations in patients who develop clinical signs of infection. Penicillin did not appear to influence this progression.
Clinical Implications. Antibiotics are not effective in preventing the development of odontogenic infection when definitive dental therapy cannot be provided for acute pain in the absence of clinical signs of infection. Although the overall risk of developing infection is low, early treatment is indicated for teeth with larger periapical radiolucencies, amalgam restorations or both.
Key Words: Infection; antibiotics; toothache; risk factors
Patients with acute odontogenic pain frequently seek care in hospital emergency departments (EDs). Given the limitations in materials, equipment and dental staffing, definitive care rarely is delivered in this setting. This scenario is common in general dental practice as well, in that a busy patient schedule may not allow for definitive dental treatment at the initial appointment. However, the treating physician or dentist must evaluate the patient carefully for the presence of an odontogenic infection and initiate appropriate pain management.
Antibiotics often are indicated for the treatment of overt odontogenic infections, but it is estimated that antibiotics are used inappropriately in 75 percent of cases involving dental conditions without signs of infection.1,2 We conducted a clinical trial to test our hypothesis that penicillin is not beneficial in the prevention of odontogenic infection in patients with acute dental pain but without clinical signs of infection. The results of that randomized, double-blind, placebo-controlled study demonstrate that antibiotics have no effect in preventing an odontogenic infection within one week.3 The purpose of the current study was to determine which presenting signs and symptoms were associated with the subsequent development of overt odontogenic infection.
Exclusion criteria included the following: overt signs of infection (fever, intraoral or extraoral swelling, purulence and trismus), pregnancy, immunocompromised condition, heart disease requiring antibiotic prophylaxis, antibiotic use within one month of the study or a history of acute dental trauma. All subjects reviewed and signed a consent form approved by the institutional review board of Carolinas Medical Center, Charlotte, N.C.
Baseline data.
Attending or resident emergency physicians identified and screened study patients for exclusion criteria. All eligible patients underwent a structured evaluation by a dental resident at the initial ED visit. The dental resident collected the following baseline data: demographic information; pain description, intensity (measured by a visual analog scale [VAS]) and duration; dental and periodontal assessments; results of diagnostic tests, including cold, bite stick and percussion; as well as periapical radiographic findings.
Patients indicated pain intensity on a VAS, with "no pain" and "worst pain" as the anchors. For pain description, the data entry sheet contained questions regarding whether the pain was stimulated versus spontaneous. If the patient reported that the pain was stimulated, the dental resident questioned him or her further regarding the following: whether the cold stimulus was fleeting versus lingering (< 10 seconds versus
A dental resident documented caries depth and the presence and size of periapical radiolucencies. He or she calculated the size of the periapical radiolucency as the greatest distance from the root to the border of the radiolucency. One of us (M.B.), who was a blinded investigator, confirmed the size of the radiolucency. We determined the dental diagnosis on the basis of the patient’s pain history and clinical and radiographic examination findings. Using objective and subjective data from the initial ED visit, we diagnosed patients with a symptomatic vital pulp and no signs of periapical changes as having irreversible pulpitis, and we gave a diagnosis of an abscess to patients with a nonvital pulp and periapical changes. We used a cold stimulus test (Endo-Ice, Coltène/Whaledent, Cuyahoga Falls, Ohio) in the ED to determine pulp vitality, with a positive result indicating a vital pulp and a negative result indicating a non-vital pulp.
In addition to the study medication (penicillin VK versus placebo), patients were given our hospital ED’s existing standard for analgesic medications at the ED visit: 30 ibuprofen pills (800-mg tablets) and 15 hydrocodone/acetaminophen pills (5-mg/500-mg tablets). We asked subjects to return to the hospital’s dental clinic five to seven days later for the second study evaluation and definitive dental treatment. At this dental visit, a dental resident collected the following information: presence or absence of one or more of the five signs of the primary outcome variable of infection (that is, fever, intraoral or extraoral swelling, purulence and trismus); VAS pain score; medication compliance by pill count; and adverse events.
Statistical analysis.
We calculated descriptive statistics (including means and standard deviations) or counts and percentages. At the follow-up visit, comparisons of baseline ED data were performed between patients who had an infection (FU-I) and those with no infection (FU-NI). We used a Student t test or Wilcoxon rank sum test (for ordinal data and those that were not normally distributed) to compare data measured on an interval scale between the two groups. We used the
A sample size estimate for the original, randomized, double-blind clinical trial determined that 69 subjects per group were required to detect a 15-percentage-point difference in the development of overt infection (assuming a rate of infection of 5 and 20 percent in the penicillin and placebo groups, respectively). For subjects who did not return for the follow-up visit in the dental clinic, we searched the computerized records of our multifacility health care system for any non-study return visits to the ED or dental clinic. If adequate outcome data were available from these visits, we included them in the final analysis.
The main outcome—overt dental infection—was present in 13 (10 percent) of 134 subjects at the follow-up visit. As reported previously,3 we found no differences at the follow-up dental clinic visit in the outcomes of infection, pain, compliance or adverse events between patients randomized to antibiotics or to placebo (Table 1
SUBJECTS AND METHODS
TOP
ABSTRACT
SUBJECTS AND METHODS
RESULTS
DISCUSSION
CONCLUSION
REFERENCES
We conducted a randomized, double-blind, placebo-controlled trial of adult patients in a busy ED (105,000 visits per year) at an urban teaching hospital. Patients with dental pain but without overt signs of dental infection were enrolled from February 2000 to October 2001. Patients were randomized via a computer-generated numbering scheme to receive penicillin (500 milligrams) or a placebo four times per day for seven days. 
10 seconds), whether the sweet stimulus was fleeting versus lingering (< 10 seconds versus 10 seconds) and whether the hot stimulus was fleeting versus lingering (< 10 seconds versus 10 seconds). The dental resident also asked patients to describe the severity and character of their pain and recorded this information on the data entry sheet. 
2 test or Fisher exact test for dichotomous data. A P value of less than .05 was considered statistically significant. We used statistical software (SAS, Version 8.2, SAS Institute, Cary, N.C.).
RESULTS
TOP
ABSTRACT
SUBJECTS AND METHODS
RESULTS
DISCUSSION
CONCLUSION
REFERENCES
We enrolled 195 subjects in the ED, with 125 (64 percent) returning for the follow-up dental care visit. For the remaining 70 subjects (36 percent) who did not return, a search of ED and dental clinic visits within one month of enrollment identified nine additional subjects who returned to our hospital owing to dental pain, infection or both. Therefore, follow-up data were available for 134 (69 percent) of 195 subjects. 
). Table 2 presents a comparison of the baseline ED data between FU-I subjects and FU-NI subjects. There were no differences in demographic data, pain variables or dental diagnostic test results between the two groups. We found no statistical differences in the dental diagnosis at the ED visit between the FU-I and FU-NI groups.
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). Radiographic analysis from the ED visit demonstrated that the mean size of the periapical radiolucency was larger in the FU-I group than in the FU-NI group (P = .03) (Table 2). |
DISCUSSION |
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TOPABSTRACTSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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Possible risk factors. A wide variety of subjective and objective clinical and radiographic variables have been proposed as risk factors for the development of postendodontic flare-up. Previous clinical trials that examined risk factors for the development of odontogenic infection were conducted in an endodontic practice setting, in which definitive endodontic treatment was provided at the first visit.4–9
In a retrospective study of 1,000 endodontic patients who had experienced an interappointment flare-up (pain, swelling or both) compared with 1,000 patients who had not experienced an interappointment flare-up, Torabinejad and colleagues4 identified the following risk factors: age, 40 to 59 years; female sex; treated mandibular first molars; presence of allergies; and preoperative pain and swelling. We found it interesting that larger periapical lesions were associated with fewer interappointment emergency visits. In another prospective study of 946 endodontic patients, Walton and Fouad5 reported that a small percentage experienced interappointment flare-ups (3.7 percent, n = 30), and they identified the following risk factors: severe pain or swelling at the initial visit, diagnosis of a necrotic pulp and an acute apical abscess.
Neither of these studies made a distinction in the statistical analysis between a flare-up that was associated with infection and pain and a flare-up that was associated with pain only, and it is not possible to draw conclusions regarding risk factors for the development of infection from such small numbers of patients with interappointment flare-ups (37 [1.9 percent] of 1,946). Therefore, it is difficult to compare these findings with those of our study, which considered only infection as the main outcome. Providing definitive dental treatment is not realistic in the ED setting. Thus, our study reflects a more common clinical scenario and provides an opportunity to prospectively assess possible risk factors for the development of an odontogenic infection.
Use of antibiotics. The literature is controversial with regard to the issue of the benefit of antibiotics in the prevention of interappointment flare-ups in endodontically treated, asymptomatic necrotic teeth and in teeth with a localized acute apical abscess with no evidence of swelling.6–10 Our data, along with those of previous studies, have shown no benefit from antibiotics in the prevention of infection before the definitive dental treatment visit, thus calling into question the widespread use of antibiotics in the absence of overt infection. Fouad and colleagues10 suggested that a poor blood supply associated with the necrotic tissue of an abscess may explain why antibiotics have no effect on a localized periapical abscess.
We have discussed the limitations of this prospective clinical trial elsewhere.3 Other limitations of this analysis of risk factors include the following: the low incidence of infection (n = 13), which limited the statistical assessment to a univariate analysis compared with a more ideal statistical analysis (for example, logistic regression) of baseline ED information; and our inability to determine a dental diagnosis from the objective and subjective data for 41 (31 percent) of 134 patients, owing to a missing or nondiagnostic periapical radiograph.
Despite this, we had complete data for 93 patients, which allowed for statistical analysis of dental diagnostic and radiographic information, although the study was powered for the randomized, double-blind, placebo-controlled trial and not for an assessment of risk factors.
Finally, we did not have a standardized protocol (for example, use of a positioning device) to ensure that the radiographic unit was used at the same angle for each periapical radiograph. This may have overestimated or underestimated the size of periapical radiolucencies. We used the same radiographic unit, processor and type of dental film in the ED for each patient.
We examined whether tooth location had an impact on the presence of an amalgam restoration or the size of a periapical radiolucency. We found no differences in these two outcomes according to tooth type in the FU-I group. Six teeth with amalgam restorations became infected, including three maxillary teeth (two posterior and one anterior) and three mandibular teeth (all posterior). Our comparison of the size of periapical radiolucencies demonstrated no statistical differences between the maxillary and mandibular teeth in the FU-I group.
As we reported elsewhere,3 antibiotics are neither necessary nor beneficial in the treatment of dental pain in the absence of overt infection, and eliminating this practice would reduce health care costs and minimize unnecessary antibiotic exposure. In this prospective clinical trial, few objective or subjective tests helped predict whether a patient with odontogenic pain without overt infection would develop an infection before the definitive dental treatment visit.
We found it interesting that patients with an amalgam restoration in the symptomatic tooth were more likely to develop an infection before the definitive care appointment than were patients without restorations in the symptomatic tooth. This may be a spurious finding owing to the small number of subjects who developed an infection, or it may be related to prior pulpal damage resulting from removal of a large carious lesion or from preparation and placement of a prior restoration, and/or the presence of recurrent caries in an already compromised tooth.
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CONCLUSION |
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FOOTNOTES |
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TOPABSTRACTSUBJECTS AND METHODSRESULTSDISCUSSIONCONCLUSIONREFERENCES |
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