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Study flow diagram.
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Study flow diagram.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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

Core elements

Issues to consider

Status 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 setting

Inclusion 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 factor

Any 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 factor

Placebo 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 recommendation

27 January 2016

Study type

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

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

Number of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Antibiotics

Patient‐reported pain intensity
(sum of pain intensity difference (SPID) and sum of pain percussion intensity difference (SPPID))

Study population

Not estimable

40
(1 study)

⊕⊕⊝⊝
low1

The in‐between group differences in SPID and SPPID were not statistically significant2

Moderate

Patient‐reported pain relief ‐ not reported

See comment

See comment

Not estimable

‐

See comment

Not assessed

Total number of ibuprofen tablets

The 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 tablets

The 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 reported

See comment

See comment

Not estimable

‐

See comment

Not 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.

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Summary of findings for the main comparison. Antibiotics for irreversible pulpitis
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Table 1. Baseline pain and percussion values for penicillin and placebo groups

Penicillin

Placebo

Initial pain (median & interquartile range)

2.00 +/‐ 0.00

2.00 +/‐ 1.00

Initial percussion pain (median & interquartile range)

2.00 +/‐ 0.50

2.00 +/‐ 1.00

Pain ratings: moderate

65%

80%

Pain ratings: severe

35%

20%

Percussion pain ratings: mild

20%

25%

Percussion pain ratings: moderate

50%

65%

Percussion pain ratings: severe

30%

10%
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Table 1. Baseline pain and percussion values for penicillin and placebo groups
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Table 2. Sum of pain and percussion pain intensity difference

Penicillin

Placebo

P value

Sum of pain intensity difference (median and interquartile range)

6.0 +/‐ 10.5

6.0 +/‐ 9.5

.776

Sum of percussion pain intensity difference (median and interquartile range)

3.5 +/‐7.5

2.0 +/‐ 7.0

.290
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Table 2. Sum of pain and percussion pain intensity difference
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Table 3. Use of pain medication for penicillin and placebo groups (n and quantity)

Day

n Ibuprofen

n Tylenol

Nil pain medication

DAY 1

Penicillin

17 (85%)

10 (50%)

1 (5%)

No of tablets

33

21

0

Placebo

16 (80%)

8 (40%)

0

No of tablets

28

11

0

DAY 2

Penicillin

17 (85%)

10 (50%)

0

No of tablets

30

28

0

Placebo

16 (80%)

9 (45%)

1 (5%)

No of tablets

31

18

0

DAY 3

Penicillin

13 (65%)

9 (45%)

4 (20%)

No of tablets

27

20

0

Placebo

15 (75%)

8 (40%)

3 (15%)

No of tablets

28

14

0

DAY 4

Penicillin

12 (60%)

9(45%)

6 (30%)

No of tablets

24

23

0

Placebo

17 (85%)

5 (25%)

2 (10%)

No of tablets

28

8

0

DAY 5

Penicillin

12 (60%)

8 (40%)

7 (35%)

No of tablets

21

15

0

Placebo

16 (80%)

7 (35%)

3 (15%)

No of tablets

32

11

0

DAY 6

Penicillin

13 (65%)

8 (40%)

5 (25%)

No of tablets

24

15

0

Placebo

13 (65%)

6 (30%)

6 (30%)

No of tablets

24

13

0

DAY 7

Penicillin

14 (70%)

10 (50%)

4 (20%)

No of tablets

25

16

0

Placebo

11 (55%)

7 (35%)

7 (35%)

No of tablets

20

14

0
Figuras y tablas -
Table 3. Use of pain medication for penicillin and placebo groups (n and quantity)
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