Participant flow - ANZCTR



Participant flow2. Baseline characteristicsProvide a table of baseline demographic and clinical characteristics (including important pre-intervention prognostic factors) for each study group.Table SEQ Table \* ARABIC 1. Bacterial prevalence at the baseline visit across the three treatment groupsBacterial SpeciesAll Samples (n = 71)CPP-ACP(n = 22)All-in-One(n = 23)Control(n = 26)P-valueActinomyces gerensceriae70 (99%)21 (96)23 (100%)26 (100%)0.323Corynebacterium durum70 (99%)21 (96)23 (100%)26 (100%)0.323Lactobacillus gasseri13 (18%)2 (9%)4 (17%)7 (27%)0.279Neisseria flavescens63 (89%)19 (86%)22 (96%)22 (85%)0.435Provotella denticola56 (79%)17 (77%)18 (78%)21 (81%)0.954Rothia aeria/dentocariosa71 (100%)22 (100%)23 (100%)26 (100%)δStreptococcus mitis/oralis71 (100%)22 (100%)23 (100%)26 (100%)δStreptococcus mutans54 (76%)16 (73%)18 (78%)20 (77%)0.902Streptococcus parasanguinis5 (7%)0 (0%)1 (4%)4 (15%).096Streptococcus salivarius/ thermophilus71 (100%)22 (100%)23 (100%)26 (100%)δStreptococcus sanguinis71 (100%)22 (100%)23 (100%)26 (100%)δStreptococcus sobrinus2 (2.8%)0 (0%)0 (0%)2 (8%)0.168Scardovia wiggsiae42 (59%)13 (59%)13 (57%)16 (62%)0.938Veillonella parvula71 (100%)22 (100%)23 (100%)26 (100%)δBaseline prevalence data showing number of samples in which the bacterial species was detected and values in brackets representing % prevalence. No significant differences between the treatment groups at the baseline visit (P > 0.05; chi-square test). δ: no statistics computed because bacterial prevalence was a constant.Outcome measuresTable 2. Fold change in bacterial loads from baseline to recall visit with pairwise treatment group comparisonsTreatment GroupsP-valuesBacterial SpeciesCPP-ACPAll-in-OneControlCPP-ACP versusControlAll-in-OneVersusControlCPP-ACP versusAll-in-OneActinomyces gerensceriae0.33 ± 0.120.47 ± 0.17 0.85 ± 0.170.2810.8161.00Corynebacterium durum14.45 ± 0.176.61 ± 0.131.92 ± 0.070.007*0.2070.579Lactobacillus gasseri0.94 ± 0.200.75 ± 0.080.95 ± 0.271.001.001.00Neisseria flavescens2.05 ± 0.0912.27 ± 0.02 0.64 ± 0.080.5710.003*0.158Provotella denticola2.18 ± 0.021.89 ± 0.044.74 ± 0.051.001.001.00Rothia aeria/dentocariosa0.97 ± 0.241.65 ± 0.100.54 ± 0.390.6640.0600.842Streptococcus mitis/oralis0.84 ± 0.150.98 ± 0.090.65 ± 0.201.001.001.00Streptococcus mutans0.52 ± 0.150.23 ± 0.072.51 ± 0.200.032*< 0.001*0.555Streptococcus parasanguinis0.56 ± 0.480.40 ± 0.110.37 ± 0.061.001.001.00Streptococcus salivarius0.67 ± 0.140.57 ± 0.181.21 ± 0.200.7480.4261.00Streptococcus sanguinis2.92 ± 0.263.44 ± 0.240.46 ± 0.29< 0.001*< 0.001*1.00Streptococcus sobrinus0.61 ± 0.490.60 ± 0.300.72 ± 0.271.001.001.00Scardovia wiggsiae0.57 ± 0.071.01 ± 0.091.52 ± 0.070.5701.001.00Veillonella parvula0.31 ± 0.170.11 ± 0.091.10 ± 0.300.061< 0.001*0.213Fold change values (mean ± S.D) for each bacterial species in the CPP-ACP group (n = 22), All-in-One group (n = 23) and control group (n = 26). Ratio below 1 indicates lower relative abundance; a ratio above 1 indicates higher relative abundance. Comparison for all pairs of treatment groups was using the Bonferroni post hoc test and * indicates where significant differences were found between the interventional group and the control group (P < 0.05). No differences were found between the two interventional groups for any bacterial species (P > 0.05).Figure 1 (A and B). Fold change in relative bacterial abundance from baseline to recall visit.* indicates significant differences using the one-way ANOVA and Simes adjustment for the multiple bacterial comparisons.4. Adverse events/harmsNO adverse effects or harms were reported by any of the trial participants in any of the three treatment groups. ................
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