Evaluation of the effect of choline-stabilized orthosilicic acid (CS-OSA) on osseointegration and the prevention of peri-implantitis

ISRCTN	ISRCTN13455959
DOI	https://doi.org/10.1186/ISRCTN13455959
Sponsor	Bio Minerals NV
Funder	Bio Minerals NV

Submission date: 13/01/2026
Registration date: 15/01/2026
Last edited: 06/02/2026

Recruitment status: Not yet recruiting
Overall study status: Ongoing
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Dental implants are a widely used and effective solution for tooth replacement, with high long-term survival rates. Nevertheless, inflammatory conditions around osseointegrated implants are common. When inflammation is confined to the peri-implant soft tissues it is referred to as peri-implant mucositis, whereas peri-implantitis additionally involves progressive loss of supporting bone. Five to ten years after implant placement, up to one in five patients may develop peri-implantitis, and currently no gold standard exists for its prevention.
Silicon is an essential trace element implicated in bone formation and connective tissue health. Orthosilicic acid (OSA) is the bioavailable form of silicon, but its instability limits its use. Choline-stabilized orthosilicic acid (CS-OSA) is a proprietary, stable, and bioavailable form of silicon that has been shown to stimulate collagen synthesis and positively influence bone metabolism. Previous randomized, double-blind, placebo-controlled studies demonstrated beneficial effects of CS-OSA on bone turnover, bone mineral density, joint health, and connective tissue integrity. Moreover, an exploratory clinical study in patients with peri-implantitis suggested that CS-OSA may stabilize peri-implant bone levels and support mucosal tissue healing following surgical treatment.
Based on these findings, systemic supplementation with CS-OSA may contribute to improved osseointegration of dental implants and reduce the risk of peri-implant tissue breakdown and bone loss.
This study will investigate the long-term effect of oral CS-OSA supplementation on the osseointegration of newly placed dental implants and on the prevention of peri-implantitis and associated peri-implant bone loss in comparison with placebo.

Who can participate?
Adults between the ages of 18 and 75 years for whom placement of a dental implant is required.

What does the study involve?
Participants are randomly allocated to receive either CS-OSA or a placebo in a double-blind manner. Study supplementation starts one month before implant placement and continues for a total duration of 41 months. All participants receive a dental implant and standard dental care according to clinical guidelines.
Clinical, radiographic and stability assessment of the implant and surrounding tissues are performed at regular intervals after implant, abutment and crown placement, up to 36 months after placement of the crown. These assessments include measurement of implant stability, gum health, bone levels and participant-reported quality of life.

What are the possible benefits and risks of participating?
CS-OSA may support implant integration, help maintain healthy peri-implant tissues and reduce the risk of peri-implantitis. Based on available safety data, there are no foreseeable risks to human health when CS-OSA is used as instructed.

Where is the study run from?
Bio Minerals NV (Belgium). Department of Periodontology, Faculty of Dentistry, Cukurova University (Turkey)

When is the study starting and how long is it expected to run for?
February 2026 to January 2031

Who is funding the study?
Bio Minerals NV (Belgium)

Who is the main contact?
Prof. Dr. M. Cenk Haytac, D.D.S., Ph.D., cenkhaytac@yahoo.com

Contact information

Dr Mehmet Cenk Haytac
Principal investigator

Department of Periodontology
Faculty of Dentistry
Cukurova University
Adana
01330
Türkiye

ORCID ID	0000-0001-5683-3667
Phone	+90 532 431 57 43
Email	cenkhaytac@yahoo.com

Dr Stien De Coninck
Public, Scientific

Bio Minerals NV
Zenderstraat 12
Destelbergen
9070
Belgium

ORCID ID	0000-0003-0777-8205
Phone	+32 (0)472 08 00 67
Email	stien.deconinck@biominerals.be

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Blinded (masking used)
Control	Placebo
Assignment	Parallel
Purpose	Prevention
Scientific title	A randomized, double-blind, placebo-controlled study to assess the long-term effects of choline-stabilized orthosilicic acid (CS-OSA) on osseointegration and the onset of peri-implantitis
Study acronym	20/2
Study objectives	The aim of the study is to evaluate the effect of long-term oral intake of choline-stabilized orthosilicic acid on osseointegration of newly placed dental implants and on the incidence of peri-implantitis compared to placebo.
Ethics approval(s)	1. Approved 31/08/2023, Çukurova University Ethics Committee (Çukurova University, Balcali, Adana, 01330, Türkiye; +90 (0)322 338 67 22; neclaetikkurul@gmail.com), ref: 38310148/91 2. Approved 26/11/2024, Çukurova University Clinical Research Ethics Committee (Cankaya, Ankara, 06520, Türkiye; +90 (0)312 218 30 00; halkla.iliskiler@titck.gov.tr), ref: 23-AKD-245
Health condition(s) or problem(s) studied	Peri-implantitis
Intervention	Subjects are randomized to either the placebo or active treatment group (choline-stabilized orthosilicic acid) using block randomization in a ratio of 1:1. All subjects will be instructed to take daily for 41 months, 2 capsules orally of either placebo (520 mg microcrystalline cellulose beadlets per capsule), or the active ingredient (520 mg beadlets containing 5 mg of silicon and 100 mg of choline in the form of choline-stabilized orthosilic acid per capsule). The trial starts with a screening visit and a wash-out period during which the use of peri-implantitis treatment is not permitted. Assessments will be done respectively at inclusion (pre-baseline) and after 1, 4, 5, 11, 17, 23, 29, 35 and 41 months of treatment.
Intervention type	Supplement
Primary outcome measure(s)	The incidence of peri-implantitis defined as “bone loss of 3 or more than 3 mm apical of the most coronal portion of the intraosseous part of the implant and PPD of more than 4 mm with bleeding on probing or pus on probing” measured using intra-oral periapical radiographic measurements around the implant and periodontal probing at 24 months after placement of the crown (baseline, T0 visit) on the newly placed implant(s)
Key secondary outcome measure(s)	The incidence of peri-implantitis defined as “bone loss of 3 or more than 3 mm apical of the most coronal portion of the intraosseous part of the implant and PPD of more than 4 mm with bleeding on probing or pus on probing" measured using intra-oral periapical radiographic measurements around the implant and periodontal probing at 6, 12, 18, 30 and 36 months after placement of the crown (baseline, T0 visit) on the newly placed implant(s) The incidence of peri-implant mucositis defined as “bleeding on probing or pus on probing around the implant and absence of bone loss beyond crestal bone level changes resulting from initial bone remodeling” measured using periodontal probing and intra-oral periapical radiographic measurements around the implant at 6, 12, 18, 24, 30 and 36 months after placement of the crown (baseline, T0 visit) on the newly placed implant(s) The Periotest Value (PTV), or change in PTV measured using the Periotest device at placement of the abutment (−T1 visit), placement of the crown (baseline, T0 visit) and at 6, 12, 18, 24, 30 and 36 months after placement of the crown on the newly placed implant(s) The Implant Stability Quotient (ISQ) value, or change in ISQ measured using Resonance Frequency Analysis (RFA) at placement of the implant (−T4 visit), placement of the abutment (−T1 visit) and placement of the crown (baseline, T0 visit) on the newly placed implant(s) Probing pocket depth (PPD), or change in PPD, measured using periodontal probing at implant sites at placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 or 36 months after placement of the crown on the newly placed implant(s) Gingival recession (REC), or change in REC, measured using periodontal probing at implant sites at placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 and 36 months after placement of the crown on the newly placed implant(s) Clinical attachment level (CAL), or change in CAL, measured using periodontal probing at implant sites at placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 or 36 months after placement of the crown on the newly placed implant(s) Bleeding on probing (BOP), or change in BOP, measured using periodontal probing at implant sites at placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 and 36 months after placement of the crown on the newly placed implant(s) Plaque index (PI), or change in PI, measured using the “modified Quigley and Hein Index” at implant sites at placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 and 36 months after placement of the crown on the newly placed implant(s) The gingivitis index (GI), or change in GI, measured using the “Löe and Silness Index” at implant sites at placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 and 36 months after placement of the crown on the newly placed implant(s) Bone parameters (including bone loss, density and quality) measured using cone beam computed tomography (CBCT) and intra-oral periapical radiographic measurements at screening, after placement of the implant (−T4 visit), placement of the abutment (−T1 visit), placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 and 36 months after placement of the crown on the newly placed implant(s) The loss of implants measured using clinical assessment at 6, 12, 18, 24, 30 or 36 months after placement of the crown (baseline, T0 visit) on the newly placed implant(s) Degree of inflammation, or change in degree of inflammation, measured using clinical photographs evaluated by periodontists using a visual analogue scale (VAS; 0 = low degree of inflammation, 100 = high degree of inflammation) at placement of the crown (baseline, T0 visit) and 6, 12, 18, 24, 30 and 36 months after placement of the crown on the newly placed implant(s) The participant's oral health–related quality of life, or change in quality of life, measured using the Oral Health Impact Profile questionnaire (OHIP-14) at placement of the crown (baseline, T0 visit) and 12, 24 and 36 months after placement of the crown on the newly placed implant(s)
Completion date	31/01/2031

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	240
Key inclusion criteria	1. Provision of written informed consent. 2. Males and Females between the ages of 18 years old and 75 years old. 3. Females must use an approved form of birth control or be postmenopausal or be surgically sterile. 4. Subjects for whom implant placement is required. If tooth extractions are needed, the extraction should be performed at least two months before implant placement. 5. Subjects who are willing to place Nucleoss T6 implants, Medentika and Dentium. 6. Placement needed of single implants with single crown.
Key exclusion criteria	1. Subject is unable to understand the study procedures and/or not having given written informed consent and/or not wishing to participate in one of the subsequent therapeutic intervention protocols. 2. Poor general health interfering with compliance or assessment. 3. Unlikely to co-operate fully in the study. 4. Participating in another clinical trial in the last 90 days. 5. Pregnancy or breastfeeding. 6. Gingival index > 2. 7. Subjects who are not willing to place Nucleoss T6 implant, Medentika or Dentium. 8. Total edentulous subjects. 9. Exclusive placement of implant bridges. 10. Tooth extractions performed less than 2 months before implant placement. 11. Active, untreated periodontitis. 12. Previous bone augmentation procedures. 13. Subjects with documented poorly controlled diabetes (Glycated hemoglobin (HbA1c) level >6%). 14. Subjects with osteoporosis. 15. Osteonecrosis of the jaw. 16. Recent or current alcohol abuse (consumption levels of more than 28 units per week) and drug abuse. 17. Subjects with documented, active infection diseases (included but not limited to HIV, hepatitis B/C). 18. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator. 19. Subjects with current active treatment for renal failure or cancer. 20. Subjects with documented history of stroke or myocardial infarct. 21. Concomitant and previous medication: 21.1 Concomitant and previous treatment with bisphosphonates. 21.2. Concomitant treatment with local antiseptica i.e. rinsing solutions to disinfect the mouth (i.e. Hextril/Hexiditine, Corsodyl). Exception!: chlorhexidine-digluconate rinsing is allowed for treatment until one week after implant placement. 21.23. Concomitant and previous supplementation with food supplements containing horsetail extract, bamboo extract, silicic acid or silanol derivatives within 3 months of the start of the study.
Date of first enrolment	22/02/2026
Date of final enrolment	22/07/2027

Locations

Countries of recruitment

Türkiye

Study participating centre

Cukurova University, Department of Periodontology, Faculty of Dentistry

Cukurova University
Adana
01330
Türkiye

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Published as a supplement to the results publication
IPD sharing plan	The datasets generated and/or analysed during the current study will be published as a supplement to the results publication.

Editorial Notes

06/02/2026: The following changes were made:
1. Date of first enrolment was changed from 22/01/2026 to 22/02/2026.
2. Individual participant data (IPD) sharing plan was added.
14/01/2026: Study’s existence confirmed by the Çukurova University Clinical Research Ethics Committee, Turkey.