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Randomized Controlled Trial
. 2021 Sep 29;21(1):485.
doi: 10.1186/s12903-021-01817-4.

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

Wim Teughels #  1 , Gizem Unal Celik #  2 , Mihai Tarce  1 , Ine De Cock  3 , Sara M Persyn #  4 , Mehmet C Haytac #  2
Affiliations
Randomized Controlled Trial

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

Wim Teughels et al. BMC Oral Health. .

Abstract

Background: Choline-stabilized orthosilicic acid (CS-OSA) was previously found to stimulate bone collagen formation in osteopenia and to improve biomarkers of cartilage degradation in knee osteoarthritis. The aim of the present study was to investigate the effect of oral administration of CS-OSA on clinical symptoms of peri-implantitis and the associated bone loss.

Methods: Twenty-one patients with peri-implantitis were randomized in CS-OSA or placebo groups. After initial clinical and cone beam computed tomography (CBCT) measurements [probing pocket depth (PPD), bleeding on probing (BOP), mucosal recession (REC), distance from implant shoulder to alveolar crest (IS-AC) and distance from implant shoulder to first bone-to-implant contact (IS-BIC)], flap operations were performed at the peri-implantitis sites. All patients were instructed to use either placebo or CS-OSA capsules twice a day for 1 year. Measurements were repeated 6 and 12 months after randomization.

Results: The data of 18 patients (36 implants) were used in the per protocol analysis. PPD and BOP improved significantly (p < 0.05) compared to baseline for both groups after 6 and 12 months. However, REC significantly increased in the placebo group but not in the CS-OSA group. The change in REC over 6 and 12 months was significantly different between groups (p < 0.01). IS-BIC and IS-AC measurements remained stable in the CS-OSA group whereas in the placebo group, both parameters increased significantly after 6 and 12 months. The change in IS-BIC over 12 months was significantly different between groups (p < 0.05).

Conclusion: The results of this preliminary study suggest that CS-OSA may stabilize and even prevent further bone loss after surgical peri-implantitis treatment and support mucosal tissue healing. Trial registration The trial was retrospectively registered at ISRCTN registry, registration number: ISRCTN14348802, registration date: 24/06/2020.

Keywords: Bone; Choline-stabilized orthosilicic acid; Mucosal recession; Peri-implantitis.

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Conflict of interest statement

SMP and IDC are employed as research associates of the study sponsor Bio Minerals NV (Belgium, the manufacturer of choline-stabilized orthosilicic acid). MCH has received financial support from Bio Minerals NV to conduct the study. WT, GUC and MT report no conflicts of interest related to this study.

Figures

Fig. 1
Fig. 1
Right images (b, d): Cone beam computed tomography (CBCT) slices illustrating the measured parameters: distance from implant shoulder to first bone-to-implant contact (IS-BIC; blue) and distance from implant shoulder to alveolar crest (IS-AC; red) at the lingual, buccal, mesial and distal aspects of the implants. The level of the implant shoulder (IS) and the long axis of the implant are marked in green. Left images (a, c): 3D volume rendering of the jaw and the cross-sections (yellow plane) made to perform the measurements illustrated in the images on the right. The measurements were performed on two perpendicular planes passing through the long axis of each implant and oriented mesio-distally and bucco-orally, respectively
Fig. 2
Fig. 2
Flow diagram of study enrolment, allocation, follow-up and analysis. CBCT: cone beam computed tomography; CS-OSA: choline-stabilized orthosilicic acid
Fig. 3
Fig. 3
Mucosal recession (REC) at baseline, 6 months and 12 months of treatment with choline-stabilized orthosilicic acid (CS-OSA) compared to placebo. Data is presented as mean with 95% confidence interval (CI). The insert box shows the difference in difference (DID) between baseline and 6 months (T0-T6), baseline and 12 months (T0-T12) and 6 months and 12 months (T6-T12) of treatment with placebo and CS-OSA. *p < 0.05 vs baseline (within placebo); #p < 0.05 vs placebo. n = the amount of implant sites
Fig. 4
Fig. 4
Distance from the implant shoulder to first bone-to-implant contact (IS-BIC) at baseline, 6 months and 12 months of treatment with choline-stabilized orthosilicic acid (CS-OSA) compared to placebo. Data is presented as mean with 95% confidence interval (CI). The insert box shows the difference in difference (DID) between baseline and 6 months (T0–T6), baseline and 12 months (T0-T12) and 6 months and 12 months (T6-T12) of placebo and CS-OSA treatment. *p < 0.05 vs. baseline (within placebo). n = the amount of implant sites
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