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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