Adjunctive Effect of the Metronidazole: Amoxicillin Antibiotic Combination in the Treatment of GAP

calendar
22 Oct, 19

Introduction

The first step in the treatment of generalized aggressive periodontitis (GAP) is a cause-related treatment phase aimed at the reduction and/or elimination of the pathogenic microflora. Adjunctive systemic antibiotics may benefit aggressive periodontitis patients during non-surgical therapy.

Aim

A randomized placebo-controlled, parallel-design, double-blind clinical trial with 6-month follow-up study assessed the adjunctive clinical effect of the administration of systemic amoxicillin and metronidazole in the non-surgical treatment of GAP.

Patient Profile

  • Forty-one patients referred to the periodontal clinic of the Eastman Dental Hospital, London
  • GAP (according to the criteria of the 1999 international classification (Armitage 1999)
  • at least 20 teeth present
  • good general health
  • age between 16 and 35 when first diagnosed with aggressive periodontal disease
Table 1: Baseline Characteristics

Parameter

Test group

(N= 20)

Placebo group

(N =21)

p-value

Age

31.3

31.7

0.779

Females (percentage)

16

12

0.108

Smokers (percentage)

5

4

0.719

Caucasians (percentage)

13

10

0.530

Teeth at baseline

25.5

26.0

0.482

Number of pockets >5 mm

60.8

58.4

0.795

Percentage of pockets >5 mm

35.5

31.5

0.514

Full-mouth plaque score

25.5

20.0

0.155

Full-mouth bleeding score

61.5

55.0

0.175

Methods

Patients received a course of full-mouth non-surgical periodontal treatment delivered over a 24 h period using machine-driven and hand instruments

Clinical parameters were collected at baseline, and at 2- and 6-months post-treatment

Intervention

The adjunctive course of systemic antibiotic consisting of 500 mg amoxicillin and 500 mg metronidazole three times a day for an adjunctive day.

Study Outcomes

  • Primary outcomes:  Probing Pocket Depth (PPD) reduction in sites with initial PPD >7 mm
  • Secondary outcomes: Differences between groups for the
  • changes in mean full-mouth PPD and the changes in PPD and life cumulative attachment loss (LCAL) at different initial PPD categories
  • changes in Full-mouth plaque score (FMPS) and full-mouth percentage bleeding score (FMBS)
  • percentage of sites with PPD reduction or LCAL gain of >2 mm
  • percentage of sites that showed LCAL loss >2mm (disease progression)
  • percentage of sites with PPD changing from >5 to <4mm and the percentage of sites with PPD changing from <4 to <3mm (need for re-treatment)
  • description and frequency of adverse events
  • compliance with the systemic medication

Results

  • In both the test and the placebo groups, all clinical parameters improved at 2 and 6 months
  • Highly significant treatment effects for full-mouth PPD reduction, PPD reduction at 4–6mm pockets and PPD reduction at<7mm pockets at 2 and 6 months
Table 2: PPD reduction and LCAL gain at 2 and 6 months in different pockets categories

Multivariate ‘‘ANCOVA’’ analysis models

Parameter

Difference

0–2 months

Difference 0–6 months

 

 

estimate

p-value

estimate

p-value

Full-mouth mean PPD reduction

Treatment group (test-placebo)

0.3

0.5

 

 

Smoking (no-yes)

0.4

0.4

 

Mean PPD reduction in pockets 4–6 mm

Treatment group (test-placebo)

0.5

0.4

 

 

Smoking (no-yes)

0.4

0.2

 

Mean PPD reduction in pockets X7 mm

Treatment group (test-placebo)

0.9

1.4

<0.001

 

Smoking (no-yes)

0.9

1.0

 

Mean LCAL gain in sites with initial PPD X7 mm

Treatment group (test-placebo)

0.6

1.0

<0.001

 

Smoking (no-yes)

0.6

0.7

 

Mean LCAL gain in sites with initial PPD 4–6 mm

Treatment group (test-placebo)

0.2

0.5

 

 

Smoking (no-yes)

0.0

0.0

 

  • In addition, the 6-month data showed LCAL gains > 2mm at 25% of sites in test patients compared with 16% in placebo (p=0.028)
  • Similarly, PPD reductions of 2mm or more were observed in 30% of sites in test and 21% of sites in placebo patients
  • Seventy-four percent of pockets with PPD > 5mm at baseline were 4mm or shallower at 6 months in the test group compared with 54% in the placebo group (p=0.008)
  • The effects of both treatments had a large impact on bleeding, and these changes were statistically significant at 2 and 6 months (p<0.001)
  • Disease progression at 6 months was observed at 1.5% of the test and 3.3% of sites in test and placebo, respectively (p=0.072)

Conclusions

  • The study findings indicated that a 7-day adjunctive course of systemic metronidazole and amoxicillin significantly improved the short-term clinical outcomes of full-mouth non-surgical periodontal debridement in subjects with GAP
  • Adjunctive use of systemic amoxicillin plus metronidazole, during full-mouth non-surgical cause-related periodontal treatment (FSR), performed within 24 h, has resulted in significant additional improvements in the clinical conditions of GAP patients when compared with FSR alone
  • Patients with generalized aggressive periodontitis may benefit from the adjunctive administration of amoxicillin and metronidazole during the initial phase of periodontal treatment

J Clin Periodontol.2005;32:1096–1107.doi:10.1111/j.1600-051X.2005.00814.x