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Davanje antibiotika za ireverzibilni pulpitis

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Referencias

References to studies included in this review

Nagle 2000 {published data only}

Nagle D, Reader A, Beck M, Weaver J. Effect of systemic penicillin on pain in untreated irreversible pulpitis. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology & Endodontics 2000;90(5):636‐40.

References to studies excluded from this review

Fouad 1996 {published data only}

Fouad AF, Rivera EM, Walton RE. Penicillin as a supplement in resolving the localized acute apical abscess. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology & Endodontics 1996;81(5):590‐5.

Henry 2001 {published data only}

Henry M, Reader A, Beck M. Effect of penicillin on postoperative endodontic pain and swelling in symptomatic necrotic teeth. Journal of Endodontics 2001;27(2):117‐23.

Nusstein 2003 {published data only}

Nusstein JM, Beck M. Comparison of preoperative pain and medication use in emergency patients presenting with irreversible pulpitis or teeth with necrotic pulps. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, & Endodontics 2003;96(2):207‐14.

Agnihotry 2014

Agnihotry A, Al‐Langawi J H, Khanna A. Inappropriate use of antibiotics in dentistry. Journal of the Bahrain Medical Society 2014;25(1):55‐56.

Agnihotry 2014a

Agnihotry A, Al‐Langawi J, Fedorowicz Z, Outhouse T. P192: Improving the 'Implications for Practice/Research' section of a Cochrane Review using a survey questionnaire. Abstracts of the 22nd Cochrane Colloquium; 2014 Sept 21‐26; Hyderabad, India. Available from http://cochrane‐sacn.org/cochrane/Coch‐2014SupplAbstract.pdf.

Aminoshariae 2015

Aminoshariae A, Kulild JC. Evidence‐based recommendations for antibiotic usage to treat endodontic infections and pain: A systematic review of randomized controlled trials. Journal of American Dental Association 2015 Dec 24 [Epub ahead of print].

Bergenholtz 1990

Bergenholtz G. Pathogenic mechanisms in pulpal disease. Journal of Endodontics 1990;16(2):98‐101.

Brown 2006

Brown P, Brunnhuber K, Chalkidou K, Chalmers I, Clarke M, Fenton M, et al. How to formulate research questions. BMJ 2006;333(7572):804‐6.

CDC 2008

US Centers for Disease Control and Prevention. About Antibiotic Resistance. Available from www.cdc.gov/drugresistance/community/anitbiotic‐resistance‐faqs.htm2008.

Cecic 1983

Cecic PA, Hartwell GR, Belizzi R. Cold as a diagnostic aid in cases of irreversible pulpitis. Report of two cases. Oral Surgery, Oral Medicine, Oral Pathology 1983;56(6):647‐50.

Cohen 2006

Cohen S, Hargreaves KM. Pathways of the Pulp. 9th Edition. St Louis: Mosby, 2006:17.

Colgan 2001

Colgan R, Powers JH. Appropriate antimicrobial prescribing: approaches that limit antibiotic resistance. American Family Physician 2001;64(6):999‐1004.

Cope 2015

Cope AL, Francis NA, Wood F, Chestnutt IG. Antibiotic prescribing in UK general dental practice: a cross‐sectional study. Community Dentistry and Oral Epidemiology 2015;12(3):171‐6.

Cox 1995

Cox RA, Conquest C, Mallaghan C, Marples RR. A major outbreak of methicillin‐resistant Staphylococcus aureus caused by new phage‐type (EMRSA‐16). Journal of Hospital Infection 1995;29(2):87‐106.

Hahn 1991

Hahn CL, Falkler WA, Minah GE. Microbiological studies of carious dentine from human teeth with irreversible pulpitis. Archives of Oral Biology 1991;36(2):147‐53.

Higgins 2011

Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 (updated March 2011). The Cochrane Collaboration, 2011. Available from www.cochrane‐handbook.org.

Hozo 2005

Hozo SP, Djulbegovic B, Hozo I. Estimating the mean and variance from the median, range, and the size of a sample. BMC Medical Research Methodology 2005;5:13.

Kumarasamy 2010

Kumarasamy KK, Toleman MA, Walsh TR, Bagaria J, Butt F, Balakrishnan R, et al. Emergence of a new antibiotic resistance mechanism in India, Pakistan, and the UK: a molecular, biological, and epidemiological study. Lancet Infectious Diseases 2010;10(9):597‐602.

Lipton 1993

Lipton JA, Ship JA, Larach‐Robinson D. Estimated prevalence and distribution of reported orofacial pain in the United States. Journal of the American Dental Association 1993;124(10):115‐21.

Mainjot 2009

Mainjot A, D'Hoore W, Vanheusden A, Van Nieuwenhuysen JP. Antibiotic prescribing in dental practice in Belgium. International Endodontic Journal 2009;42(12):1112‐7.

Matthews 2003

Matthews DC, Sutherland S, Basrani B. Emergency management of acute apical abscesses in the permanent dentition: a systematic review of the literature. Journal of the Canadian Dental Association 2003;69(10):660.

Onkunseri 2012

Okunseri C, Okunseri E, Thorpe JM, Xiang Q, Szabo A. Patient characteristics and trends in nontraumatic dental condition visits to emergency departments in the United States. Clinical, Cosmetic and Investigational Dentistry 2012;16(4):1‐7.

Palmer 2003

Palmer NA. Revisiting the role of dentists in prescribing antibiotics. Dental Update 2003;30(10):570‐4.

RevMan 2014 [Computer program]

The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). Version 5.3. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2014.

Schulz 1995

Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. Journal of the American Medical Association 1995;273(5):408‐12.

Segura‐Egea 2010

Segura‐Egea JJ, Velasco‐Ortega E, Torres‐Lagares D, Velasco‐Ponferrada MC, Monsalve‐Guil L, Llamas‐Carreras JM. Pattern of antibiotic prescription in the management of endodontic infections amongst Spanish oral surgeons. International Endodontic Journal 2010;43(4):342‐50.

SMAC 1997

Standing Medical Advisory Committee. The path of least resistance. Standing Medical Advisory Committee Sub‐Group on Antimicrobial Resistance. London: Department of Health, 1997.

Soames 1998

Soames JV, Southam JC. Oral Pathology. 3rd Edition. Oxford: Oxford University Press, 1998:51‐70.

Tronstad 1991

Tronstad L. The endodontium. Clinical Endodontics. New York: Thieme, 1991:1‐31.

Walton 2009

Walton RE. Endodontics:Principles and Practice. 4th Edition. St Louis, Missouri: Saunders Elsevier, 2009.

Yingling 2002

Yingling NM, Byrne BE, Hartwell GR. Antibiotic use by members of the American association of endodontists in the year 2000: report of a national survey. Journal of Endodontics 2002;28(5):396‐404.

References to other published versions of this review

Fedorowicz 2005

Fedorowicz Z, Keenan JV, Farman AG, Newton T. Antibiotic use for irreversible pulpitis. Cochrane Database of Systematic Reviews 2005, Issue 2. [DOI: 10.1002/14651858.CD004969.pub2]

Fedorowicz 2013

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. [DOI: 10.1002/14651858.CD004969.pub3]

Keenan 2004

Keenan JV, Farman AG, Fedorowicz Z, Newton JT. Antibiotic use for irreversible pulpitis. Cochrane Database of Systematic Reviews 2004, Issue 4. [DOI: 10.1002/14651858.CD004969]

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Nagle 2000

Methods

Prospective 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.

Participants

Adults: (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.

Interventions

Oral 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).

Outcomes

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

Notes

There were no withdrawals or drop‐outs.

Risk of bias

Bias

Authors' judgement

Support for judgement

Random sequence generation (selection bias)

Low risk

Quote: "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 risk

Quote: "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 risk

Participants/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 risk

Outcome data were complete for all of the participants.

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

Selective reporting (reporting bias)

Low risk

No 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 bias

Low risk

Quote: "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]

Study

Reason for exclusion

Fouad 1996

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

Henry 2001

This study combined antibiotic as an adjunct to endodontic treatment.

Nusstein 2003

This study was a retrospective non‐experimental study.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 2

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

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

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

Figuras y tablas -
Summary of findings for the main comparison. Antibiotics for irreversible pulpitis
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%

Figuras y tablas -
Table 1. Baseline pain and percussion values for penicillin and placebo groups
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

Figuras y tablas -
Table 2. Sum of pain and percussion pain intensity difference
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)