Evaluation of the effect of choline-stabilized orthosilicic acid in patients with gingivitis
| ISRCTN | ISRCTN12818293 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12818293 |
| Sponsor | Bio Minerals NV |
| Funder | Bio Minerals NV |
- Submission date
- 02/02/2026
- Registration date
- 18/02/2026
- Last edited
- 16/02/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and aims
Gingivitis is the earliest and reversible form of gum disease, resulting in mild symptoms such as irritation, redness, and inflammation of the gums, as well as bleeding upon gentle probing. Gingivitis is commonly induced by the accumulation of plaque on the teeth, resulting in a bacterial infection of the gums, but non-plaque-induced forms of gingivitis caused by systemic diseases are possible as well. When untreated, gingivitis can develop into periodontitis, resulting in damage to the soft tissues and bone surrounding the teeth.
A previous clinical study indicated that choline-stabilized orthosilicic acid may have a preventive role in the development of periodontitis.
This study will investigate whether choline-stabilized orthosilicic acid can improve the symptoms of gingivitis.
Who can participate?
Adults between the ages of 18 and 75 years with generalized gingivitis symptoms.
What does the study involve?
Patients are randomly allocated to either receive choline-stabilized orthosilicic acid or placebo (dummy capsule). All patients will be instructed to take two capsules daily for 6 months. Assessments will be done at the screening visit, inclusion in the study, and after 1, 3, and 6 months of treatment.
What are the possible benefits and risks of participating?
Choline-stabilized orthosilicic acid may improve gingivitis symptoms. Considering the available information about choline-stabilized orthosilicic acid, there are no foreseeable risks to human health when used as instructed.
Where is the study run from?
1. Bio Minerals NV (Belgium)
2. Dental clinic, UMC Ljubljana (Slovenia)
3. Department of Periodontology, Faculty of Dentistry, Cukurova University (Turkey)
4. Campus Universitário, Egas Moniz School of Health & Science (Portugal)
When is the study starting and how long is it expected to run for?
April 2025 to June 2027
Who is funding the study?
Bio Minerals NV (Belgium)
Who is the main contact?
Prof. Dr. Rok Gašperšič, Ph.D, rok.gaspersic@kclj.si
Contact information
Principal investigator
Dental Clinic, Department of Oral Medicine and Periodontology, UMC Ljubljana
Zaloska cesta 002
Ljubljana
1000
Slovenia
 ORCID ID |
0000-0002-3765-7378 |
|---|---|
| Phone | +386 (0)1522 4889 |
| rok.gaspersic@kclj.si |
Scientific, Public
Bio Minerals NV
Zenderstraat 12
Destelbergen
9070
Belgium
| ORCID ID |
0000-0001-8177-1138 |
|---|---|
| Phone | +32 (0)472 85 06 27 |
| mattias.bonnarens@biominerals.be |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Blinded (masking used) | |
| Control | Placebo | |
| Assignment | Single | |
| Purpose | Treatment | |
| Scientific title | A randomized, double-blind, placebo-controlled study to assess the effect of choline-stabilized orthosilicic acid on gingivitis | |
| Study objectives | The aim of the study is to evaluate the effect of oral intake of choline-stabilized orthosilicic acid on generalized gingivitis compared to placebo. | |
| Ethics approval(s) |
Approved 02/12/2024, National Medical Ethics Committee of Slovenia (Štefanova ulica 5, Ljubljana, 1000, Slovenia; +386 (0)1 478 69 06; gp.mz@gov.si), ref: 0120-492/2024-2711-4 | |
| Health condition(s) or problem(s) studied | Generalized dental plaque-induced gingivitis | |
| Intervention | Participants are randomized to either the placebo or active treatment group (choline-stabilized orthosilicic acid [CS-OSA]) using block randomization in a ratio of 1:1. All participants will be instructed to take daily for 6 months, two 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 orthosilicic acid per capsule, Bio Minerals NV). The trial starts with a screening visit and a wash-out period during which the use of treatment for gingivitis is not permitted. Assessments will be done respectively at screening, at inclusion (baseline), and after 1, 3 and 6 months of treatment. | |
| Intervention type | Supplement | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 30/06/2027 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 75 Years |
| Sex | All |
| Target sample size at registration | 160 |
| Key inclusion criteria | 1. Provision of written informed consent 2. Healthy, non-institutionalized males and females between the ages of 18 and 75 years old 3. Females must use an approved form of birth control or be postmenopausal or surgically sterile 4. A minimum of 3 natural teeth in every quadrant 5. Patients with generalized gingivitis, characterized by a BOP ≥30% |
| Key exclusion criteria | 1. Patient 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. Smoking or history of smoking (less than 6 months prior to the start of the study) 7. Patients with poorly controlled diabetes 8. Osteonecrosis of the jaw 9. Spontaneous bleeding of the gums 10. Documented history of periodontitis 11. Patient has more than 5 crowns 12. Recent or current alcohol abuse (consumption levels of more than 28 units per week) and drug abuse 13. Subjects with documented, active infectious diseases (including but not limited to HIV, hepatitis B/C) 14. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator 15. Patient has renal failure, documented history of stroke, myocardial infarction, or cancer 16. Non-plaque induced gingival diseases: 16.1. Hereditary gingival fibromatosis 16.2. Infection of bacterial, viral or fungal origin resulting in non-plaque-induced gingival lesions 16.3. Inflammatory and auto-immune conditions such as Crohn’s disease, plasma cell gingivitis, etc 16.4. Vitamin C deficiency 16.5. Traumatic lesions such as toothbrushing-induced gingival ulceration or chemical injuries 17. Concomitant and previous medication: 17.1. Concomitant and previous treatment with systemic antibiotics within 3 months of the start of the study 17.2. Concomitant treatment with local antiseptic, i.e. rinsing solutions to disinfect the mouth (i.e. Hextril/Hexiditine, Corsodyl/chlorhexidine-digluconate) 17.3. 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 17.4. Less than 3 months between the extraction of teeth and the start of the study 17.5. No other periodontal treatment is allowed during the course of the study |
| Date of first enrolment | 17/04/2025 |
| Date of final enrolment | 31/12/2026 |
Locations
Countries of recruitment
- Portugal
- Slovenia
- Türkiye
Study participating centres
Zaloska cesta 002
Ljubljana
1000
Slovenia
Adana
01330
Türkiye
Monte de Caparica
Caparica
2829-511
Portugal
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan |
Editorial Notes
02/02/2026: Study's existence confirmed by the National Medical Ethics Committee of Slovenia.
