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Table 2 Primary and secondary outcome measures and the absolute outcome scores

From: The effect of choline-stabilized orthosilicic acid in patients with peri-implantitis: an exploratory randomized, double-blind, placebo controlled study

Variable Treatment group p value
Placebo (n = 10) CS-OSA (n = 8) p value
difference in change 6 months
p value difference in change 12 months
Baseline (mean ± SD) 6 months (mean ± SD) 12 months (mean ± SD) Change 6 months—baseline (mean ± SD) Change 12 months—baseline
(mean ± SD)
Baseline (mean ± SD) 6 months (mean ± SD) 12 months (mean ± SD) Change 6 months—baseline (mean ± SD) Change 12 months—baseline (mean ± SD)
PPD (mm) 5.0 ± 2.4 c 2.8 ± 1.5a, c 2.5 ± 1.2 a, c − 2.2 ± 2.4 − 2.5 ± 2.1 6.0 ± 2.5 c 4.1 ± 2.4 a, c 3.8 ± 2.2 a, c − 2.0 ± 2.4 − 2.2 ± 2.6 0.320 0.170
BOP (%) 86.7 ± 34.1 c 35.8 ± 48.2a 30.8 ± 46.4a, c − 50.8 ± 58.0 − 55.8 ± 54.7 94.8 ± 22.3 c 40.6 ± 49.4a 50.0 ± 50.3a, c − 54.2 ± 54.1 − 44.8 ± 54.0 0.691 0.218
REC (mm) 0.8 ± 1.3 1.4 ± 1.2 a, c 1.2 ± 1.2 a, c 0.6 ± 1.0 c 0.4 ± 1.1 c 0.7 ± 1.2 0.9 ± 1.2 c 0.7 ± 1.0 c 0.2 ± 0.9 c − 0.1 ± 1.0 c 0.006 0.009
IS-AC (mm)# 2.6 ± 2.6 3.0 ± 2.7 a 3.3 ± 2.6 a 0.4 ± 1.0 0.7 ± 1.5 2.4 ± 2.2 2.8 ± 2.2 2.7 ± 2.1 0.4 ± 0.9 0.3 ± 0.9 0.859 0.254
IS-BIC (mm) # 3.8 ± 2.4 4.3 ± 2.3 a 4.6 ± 2.4 a 0.5 ± 1.3 0.8 ± 1.6 c 4.4 ± 2.0 4.7 ± 1.9 4.5 ± 2.1 0.2 ± 0.7 0.1 ± 0.8 c 0.283 0.023
OHIP Total 15.1 ± 10.8 14.0 ± 12.6 13.1 ± 7.6 − 1.1 ± 6.8 − 2.0 ± 9.1 14.6 ± 8.4 12.6 ± 8.6 10.1 ± 5.7 − 2.0 ± 10.0 − 4.5 ± 9.8 0.965 0.515
hsCRP (mg/L) 2.4 ± 2.4 2.6 ± 2.6 2.9 ± 1.6 0.2 ± 3.1 0.5 ± 1.6 4.1 ± 2.8 4.0 ± 2.5 3.6 ± 1.8 − 0.1 ± 0.8 − 0.6 ± 3.3 0.829 0.360
Osteocalcin (ng/mL) 9.0 ± 3.4 9.1 ± 2.3 9.4 ± 2.0 0.0 ± 1.9 0.4 ± 3.1 9.9 ± 3.7 9.4 ± 3.1 9.8 ± 4.5 − 0.5 ± 3.4 − 0.1 ± 2.7 0.173 0.696
BAP (µg/L) 10.2 ± 4.2 8.1 ± 3.0 a 10.3 ± 5.9 − 2.2 ± 2.0  0.1 ± 2.2 10.1 ± 1.6 8.2 ± 1.3 a 10.3 ± 2.4 − 1.9 ± 1.2 0.2 ± 2.0 0.829 0.696
CTX-I (ng/mL) 0.5 ± 0.2 0.4 ± 0.2 a 0.5 ± 0.2 b − 0.1 ± 0.1 0.0 ± 0.1 0.5 ± 0.2 0.4 ± 0.2 0.5 ± 0.2 − 0.1 ± 0.2 − 0.1 ± 0.1 0.515 0.146
PINP (ng/mL) 43.4 ± 12.6 43.2 ± 11.5 43.1 ± 13.2 − 0.1 ± 8.8 − 0.3 ± 6.6 47.0 ± 8.5 48.9 ± 22.8 44.3 ± 18.4 1.9 ± 15.7 − 2.8 ± 12.4 0.897 0.897
  1. Significant difference in changes over 6 and 12 months between groups: p < 0.05 = significant (bold). aSignificant difference from baseline within the group; bsignificant difference from 6 months within the group; csignificant difference between groups (placebo versus choline-stabilized orthosilicic acid (CS-OSA)). #IS-AC and IS-BIC analysis was performed on cone-beam computed tomography (CBCT) scans of sufficient quality (i.e. without artefacts) taken from 9 patients (19 implants) in the placebo group and 6 patients (7 implants) in the CS-OSA group. CS-OSA: choline-stabilized orthosilicic acid, PPD: probing pocket depth, BOP: bleeding on probing, REC: mucosal recession, IS-AC: distance from implant shoulder to alveolar crest, IS-BIC: distance from implant shoulder to first bone-to-implant contact, OHIP: patient’s oral health related quality of life questionnaire, hsCRP: high sensitive C-reactive protein, BAP: bone alkaline phosphatase, CTX-I: C-terminal telopeptide of collagen I, PINP: N-terminal propeptide of type I procollagen