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The mean number of shallow, moderate and deep sites at three months was also compared between the treatment groups using the ANOVA test. Finally, the magnitude of change in the mean number of sites for each PPD categories (number of sites at baseline minus number of sites at review) was compared between the treatment groups. The rationale of this analysis is outlined in the Discussion section.

This comparison was performed using the Tukey's post hoc comparison test. For all of the above analysis, a difference was considered significant if the level of statistical significance was p.

Subject retention, medication compliance and adverse effects.

Figure 1 represents the flowchart of the study design. Thirty?seven patients entered the study at baseline and completed the initial phase of treatment.

They were randomly allocated into three groups: SRP group (n = 12); A+M group (n = 13); and Az group (n = 12). All patients completed the checklist to confirm compliance of the medication regimen.

At review, five subjects were eliminated due to lack of compliance with the regimen.

One out of the four did not complete the course of medication due to developing gastro?intestinal disturbance, nausea and vomiting.

The other four did not comply for other reasons not related to adverse effects of the medication.

Hence, the sample size was reduced to 32 patients, all of which had completed the described regimen: SRP group (n = 10); A+M group (n = 11); and Az group (n = 11).

Dropped out patients were not included in the comparative statistical analysis. In the A+M group, two patients reported stomach upset and nausea, one patient experienced diarrhoea during the intake of the drugs and two patients had both stomach upset together with diarrhoea.

In other words, 5 out of the 11 patients experienced at least one adverse effect of A+M.

In the Az group, 4 out of the 11 patients reported an adverse effect.

Two stated having stomach upset, one experienced diarrhoea and one experienced an increased frequency of urination.

No adverse events were reported by the group that took the placebo (10 patients).

At baseline, no significant differences were observed between the groups for any of the demographic and clinical parameters (Table 1).

Variable SRP A+M Az p ?value Number of patients 12 13 12 ? Mean age (sd) 56.1 (12.8) 52.1 (12.2) 56.3 (9.9) 0.596 Male/Female ratio 5/7 4/9 4/8 0.910 Mean n of amoxicillin for stomach infection teeth 24.8 (3.0) 25.4 (2.8) 25.8 (1.8) 0.687 Mean n of molars 5.8 (2.7) 6.5 (2.6) 6.5 (1.4) 0.737 FMPS (%) 68.8 (17.3) 62.8 (17.9) 64.5 (16.4) 0.678 FMBS (%) 53.3 (12.5) 56.9 (21.0) 46.5 (18.8) 0.351 Mean PPD (mm) 3.93 (0.58) 3.94 (0.64) 3.67 (0.66) 0.505 Mean CAL (mm) 4.36 (0.57) 4.46 (0.77) 4.04 (0.61) 0.280 Mean n of PPD 1–3 mm 82.3 (24.1) 80.9 (27.2) 100.6 (22.1) 0.105 Mean n of PPD 4–6 mm 50.6 (16.6) 56.2 (23.8) 40.6 (15.0) 0.134 Mean n of PPD >6 mm 15.3 (15.8) 15.3 (15.5) 13.3 (17.2) 0.943.

The significance of difference between the groups at baseline was assessed using one?way ANOVA test for all the features except for Male/Female ratio where Fisher's exact test was used. Irrespective of the treatment group, there were statistically

significant

‘All sites’ clinical parameters (mean ± SD) at baseline, review and the change between the two time points. In each row, the change between baseline and review was assessed using the paired t?test.

The difference between the groups at three months was assessed using Tukey's multiple comparison test.

a Significant difference between baseline and three months review (last column on the right). b Significant difference between the groups at three months.

The reduction of mean PPD in the A+M group was significantly higher than the Az group (p?value.

For all three treatment groups, molar plaque score (MPS), molar bleeding score (MBS) and mean PPD showed a significant reduction from baseline to review (p Table 3. ‘Molar sites’ clinical parameters (mean ± SD) at baseline, review and the change between the two time points.

In each row, the change between baseline and review was assessed using the paired t?test. The difference between the groups at three months was assessed using Tukey's multiple comparison test. a Significant difference between baseline and three months review (last column on the right).

b Significant difference between the groups at three months. The reduction of bleeding score and mean PPD was significantly higher in the A+M group than the SRP group (p?value.

The data were subset into categories based on the baseline PPD. The sites were stratified into initial PPD: shallow (1–3 mm); moderate (4–6 mm) and deep (>6 mm). For each category, changes in PPD and CAL between baseline and

three

b Significant difference between the groups at three months. In the moderate sites, the reduction of mean PPD was significantly higher in the A+M group than the SRP group (p?value.

Shallow sites (1–3 mm PPD at baseline) For this category, there was no change in PPD on CAL between baseline and three months in any of the treatment groups. There was also no difference between the three groups at three months. Moderate sites (4–6 mm PPD at baseline) There was a significant reduction in PPD and increase in CAL between baseline and three months in all three treatment groups for initially moderate sites (p.