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Antibiotic use for irreversible pulpitis

  1. Zbys Fedorowicz1,*,
  2. Esther J van Zuuren2,
  3. Allan G Farman3,
  4. Anirudha Agnihotry4,
  5. Jassim Hasan Al-Langawi5

Editorial Group: Cochrane Oral Health Group

Published Online: 19 DEC 2013

Assessed as up-to-date: 5 SEP 2013

DOI: 10.1002/14651858.CD004969.pub3


How to Cite

Fedorowicz Z, van Zuuren EJ, Farman AG, Agnihotry A, Al-Langawi JH. Antibiotic use for irreversible pulpitis. Cochrane Database of Systematic Reviews 2013, Issue 12. Art. No.: CD004969. DOI: 10.1002/14651858.CD004969.pub3.

Author Information

  1. 1

    The Cochrane Collaboration, Bahrain Branch, Awali, Bahrain

  2. 2

    Leiden University Medical Center, Department of Dermatology, Leiden, Netherlands

  3. 3

    The University of Louisville School of Dentistry, Department of Surgical and Hospital Dentistry, Louisville, Kentucky, USA

  4. 4

    Mahatma Gandhi Dental College and Hospital, Department of Conservative Dentistry, Jaipur, Rajasthan, India

  5. 5

    Arabian Gulf University, College of Medicine, Salmaniya, Bahrain

*Zbys Fedorowicz, Bahrain Branch, The Cochrane Collaboration, Box 25438, Awali, Bahrain. zbysfedorowicz@gmail.com.

Publication History

  1. Publication Status: New search for studies and content updated (no change to conclusions)
  2. Published Online: 19 DEC 2013

SEARCH

 
Characteristics of included studies [ordered by study ID]
Nagle 2000

MethodsProspective randomised double-blind trial in the USA. Before the experiment, patient groups (penicillin or placebo) were assigned by using 4-digit numbers from a random number table. Only the random numbers were recorded on the data collection and postoperative diary sheets to blind the experiment.
The medications were blinded, randomised, and packaged by a pharmacy.


ParticipantsAdults: (40) 17 male, 23 female. Mean age and standard deviation (SD) in the penicillin group 30 (9.8), placebo group 34 (11.6).
2 groups of 20: penicillin group 7 women and 13 men, placebo 16 women and 4 men.

Inclusion criteria:

  • participants in "good health",
  • clinical diagnosis of irreversible pulpitis (spontaneous moderate/severe pain),
  • percussion sensitivity,
  • tooth vital to electric pulp tester (EPT) and painful response to Endo Ice,
  • radiographically widened periodontal ligament space.


Exclusion criteria:

  • tooth not responsive to EPT,
  • participants taking antibiotics or in the preceding 30 days.


InterventionsOral penicillin or placebo control (lactose) and all patients received analgesics.
7-day oral dose 500 mg 6 hourly; penicillin (Penicillin VK; Wyeth Laboratories, Philadelphia, Pa) or a placebo control (lactose).
Analgesics: 600 mg ibuprofen (Motrin; HN Norton Co, Shreveport, La); paracetamol (acetaminophen) with 30 mg of codeine (Tylenol No 3; McNeil Consumer Products, Fort Washington, Pa).


OutcomesPrimary outcomes: between-group differences in sum of pain intensity difference (SPID), sum of pain percussion intensity difference (SPPID) and quantity of pain medications taken.


NotesThere were no withdrawals or drop-outs.


Risk of bias

BiasAuthors' judgementSupport for judgement

Random sequence generation (selection bias)Low riskQuote: "Before the experiment, patient groups (penicillin or placebo) were assigned by using 4-digit numbers from a random number table."
Comment: Probably done.

Allocation concealment (selection bias)Low riskQuote: "Only the random numbers were recorded on the data collection and postoperative diary sheets to blind the experiment." "The medications were blinded, randomized, and packaged by a pharmacy."

Comment: Central randomisation, probably done.

Blinding (performance bias and detection bias)
All outcomes
Low riskParticipants/healthcare providers:
Quote: "Each 500-mg gelatin capsule of either penicillin or placebo was identical in form. The 500-mg tablets of penicillin VK were ground into a powder and placed into the clear, unlabeled gelatin capsules. The white powder of the lactose placebo was indistinguishable from the white powder of the penicillin tablets when viewed through the capsule."
Comment: Probably done.

Outcomes assessors and data analysts:
The outcomes were self assessed and as the caregivers were blinded, this was probably done.

Incomplete outcome data (attrition bias)
All outcomes
Low riskOutcome data were complete for all of the participants.

Comment: We judged this as at low risk of bias.

Selective reporting (reporting bias)Low riskNo evidence of selective choice of data for outcomes. Outcomes listed in the methods section comparable to the reported results.

Comment: We judged this as at low risk of bias.

Other biasLow riskQuote: "Supported by research funding from the Endodontic Graduate Student Research Fund and the Steve Goldberg Memorial Fund, The Ohio State University."
Comment: Appears to be free of other bias.

 
Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion

Fouad 1996This study combined antibiotic or placebo or neither as an adjunct to operative endodontic treatment in resolving the acute apical abscess.

Henry 2001This study combined antibiotic as an adjunct to endodontic treatment.

Nusstein 2003This study was a retrospective non-experimental study.

 
Summary of findings for the main comparison. Antibiotics for irreversible pulpitis

Antibiotics for irreversible pulpitis

Patient or population: Patients with irreversible pulpitis
Settings: Dental clinic
Intervention: Antibiotics

Control: Placebo

OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of participants
(studies)
Quality of the evidence
(GRADE)
Comments

Assumed riskCorresponding risk

ControlAntibiotics

Patient-reported pain intensity
(sum of pain intensity difference (SPID) and sum of pain percussion intensity difference (SPPID))
Study populationNot estimable40
(1 study)
⊕⊕⊝⊝
low1
The in-between group differences in SPID and SPPID were not statistically significant2


Moderate


Patient-reported pain relief - not reportedSee commentSee commentNot estimable-See commentNot assessed

Total number of ibuprofen tabletsThe mean total number of ibuprofen tablets in the control groups was
9.6 tablets
The mean total number of ibuprofen tablets in the intervention groups was
0.40 lower
(4.23 lower to 3.43 higher)
40
(1 study)
⊕⊕⊝⊝
low3
The administration of penicillin over placebo did not appear to significantly reduce the quantity of ibuprofen consumed for irreversible pulpitis

Total number of paracetamol (acetaminophen) + codeine tabletsThe mean total number of acetaminophen + codeine tablets in the control groups was
4.45 tablets
The mean total number of acetaminophen + codeine tablets in the intervention groups was
2.45 higher
(1.23 lower to 6.13 higher)
40
(1 study)
⊕⊕⊝⊝
low3
The administration of penicillin over placebo did not appear to significantly reduce the quantity of Tylenol consumed for irreversible pulpitis

Number of adverse events - not reportedSee commentSee commentNot estimable-See commentNot assessed

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI)
CI: confidence interval

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

 1 Small sample size, unable to use data, assume imprecise estimate
2 The between-group differences in SPID (median; interquartile range) for the penicillin group were (6.0 ± 10.5), and for placebo (6.0 ± 9.5) P value = 0.776. The SPPID (median; interquartile range) for the penicillin group were (3.5 ± 7.5) and placebo (2.0 ± 7.0) P value = 0.290
3 Small sample size and 95% confidence interval includes no effect and both the upper and lower confidence limit crosses the minimal important difference
 
Table 1. Baseline pain and percussion values for penicillin and placebo groups

PenicillinPlacebo

Initial pain (median & interquartile range)2.00 +/- 0.002.00 +/- 1.00

Initial percussion pain (median & interquartile range)2.00 +/- 0.502.00 +/- 1.00

Pain ratings: moderate65%80%

Pain ratings: severe35%20%

Percussion pain ratings: mild20%25%

Percussion pain ratings: moderate50%65%

Percussion pain ratings: severe30%10%

 
Table 2. Sum of pain and percussion pain intensity difference

PenicillinPlaceboP value

Sum of pain intensity difference (median and interquartile range)6.0 +/- 10.56.0 +/- 9.5.776

Sum of percussion pain intensity difference (median and interquartile range)3.5 +/-7.52.0 +/- 7.0.290

 
Table 3. Use of pain medication for penicillin and placebo groups (n and quantity)

Dayn Ibuprofenn TylenolNil pain medication

DAY 1

Penicillin17 (85%)10 (50%)1 (5%)

No of tablets33210

Placebo16 (80%)8 (40%)0

No of tablets28110

DAY 2

Penicillin17 (85%)10 (50%)0

No of tablets30280

Placebo16 (80%)9 (45%)1 (5%)

No of tablets31180

DAY 3

Penicillin13 (65%)9 (45%)4 (20%)

No of tablets27200

Placebo15 (75%)8 (40%)3 (15%)

No of tablets28140

DAY 4

Penicillin12 (60%)9(45%)6 (30%)

No of tablets24230

Placebo17 (85%)5 (25%)2 (10%)

No of tablets2880

DAY 5

Penicillin12 (60%)8 (40%)7 (35%)

No of tablets21150

Placebo16 (80%)7 (35%)3 (15%)

No of tablets32110

DAY 6

Penicillin13 (65%)8 (40%)5 (25%)

No of tablets24150

Placebo13 (65%)6 (30%)6 (30%)

No of tablets24130

DAY 7

Penicillin14 (70%)10 (50%)4 (20%)

No of tablets25160

Placebo11 (55%)7 (35%)7 (35%)

No of tablets20140

 
Table 4. Research recommendations based on a gap in the evidence of the effects of antibiotics for irreversible pulpitis

Core elementsIssues to considerStatus of research for this review

Evidence (E)What is the current state of the evidence?This systematic review identified 1 randomised controlled trial

Population (P)Diagnosis, disease stage, comorbidity, risk factors, gender, age, ethnic group, specific inclusion or exclusion criteria, clinical settingInclusion criteria

  • Adult patients > 18 years with a single tooth with a clinical diagnosis of irreversible pulpitis


Exclusion criteria

  • If pulpectomy is to be provided immediately

Intervention (I)Type, frequency, dose, duration, prognostic factorAny systemic antibiotic at any dosage and any analgesic at any dosage prescribed in the acute preoperative phase of irreversible pulpitis

Comparison (C)Type, frequency, dose, duration, prognostic factorPlacebo and any analgesic, at any dosage, prescribed in the acute preoperative phase of irreversible pulpitis

Outcome (O)Which clinical or patient-related outcomes will the researcher need to measure, improve, influence, or accomplish? Which methods of measurement should be used?
  • Patient-reported pain (intensity/duration) and pain relief measured on a categorical scale in the preoperative phase of irreversible pulpitis
  • Any adverse effects related to any clinically diagnosed hypersensitivity or other reactions to either the antibiotics or analgesics
  • Type, dose and frequency of medication required for pain relief

Time stamp (T)Date of literature search or recommendation5 September 2013

Study typeWhat is the most appropriate study design to address the proposed question?
  • Randomised controlled trial (adequately powered/multicentred)
  • Methods: concealment of allocation sequence
  • Blinding: participants, trialists, outcomes assessors, data analysts
  • Setting: hospital/university or general practice with adequate follow-up