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







