Condition category
Oral Health
Date applied
19/06/2020
Date assigned
24/06/2020
Last edited
24/06/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims:
For many years, dental implants prove to be a good replacement when one or more teeth are missing. Although there is a high success rate of implants, problems with inflammation around implants are frequently reported. When this inflammatory process is limited to the soft tissues such as the gums around the implant, one speaks of peri-implant mucositis. Peri-implantitis is a condition where inflammation affects both the soft tissues such as the gums around the implant and the hard tissues such as the bones surrounding the implant, therefore bone loss can be a result. Five to ten years after an implant is placed, one out of five patients suffer from peri-implantitis. Currently, there is not enough evidence or studies for the recommendation of treatments or prevention measures for peri-implantitis.

Choline-stabilized orthosilicic acid was previously found to stimulate the formation of bone collagen in patients with osteopenia and to improve signs of cartilage degradation in knee osteoarthritis. The aim of this study is to investigate the effect of choline-stabilized orthosilicic acid in peri-implantitis patients.

Who can participate?
Adults between the ages of 18 and 75 years old, with documented peri-implantitis.

What does the study involve?
Patients are randomly allocated to either receive choline-stabilized orthosilicic acid or an identical dummy pill. All patients will be instructed to take 2 capsules daily for 12 months. At the start of the study, a surgical flap will be made at all peri-implantitis sites to disinfect the area of inflammation thoroughly. Assessments will be done on inclusion to the study, and after 6 and 12 months of treatment. These will involve assessment of the implant using a probe, blood samples, a CT scan, and a questionnaire on the impact on wellbeing.

What are the possible benefits and risks of participating?
The active compound, choline-stabilized orthosilicic acid, may support soft tissue healing and prevent bone loss at the peri-implantitis affected implant sites. 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?
Department of Periodontology, Faculty of Dentistry, Cukurova University (Turkey)

When is the study starting and how long is it expected to run for?
May 2016 to January 2019

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

Who is the main contact?
Prof. dr. M. Cenk Haytac
cenkhaytac@cu.edu.tr

Trial website

Contact information

Type

Public

Primary contact

Dr Sara Persyn

ORCID ID

http://orcid.org/0000-0003-1194-8553

Contact details

Zenderstraat 12
Destelbergen
9070
Belgium
+32 (0) 9 228 20 00
sara.persyn@biominerals.be

Type

Scientific

Additional contact

Prof Mehmet Cenk Haytaç

ORCID ID

http://orcid.org/0000-0001-5683-3667

Contact details

Department of Periodontology
Faculty of Dentistry
Cukurova University
Adana
01330
Turkey
+90 532 431 57 43
cenkhaytac@cu.edu.tr

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

17/1

Study information

Scientific title

A randomized, double-blind, placebo-controlled pilot study to assess the effect of choline-stabilized orthosilicic acid on peri-implantitis

Acronym

Study hypothesis

The aim of this study is to evaluate the effect of the oral intake of choline-stabilized orthosilicic acid over a 12 month period on the clinical symptoms of peri-implantitis and associated bone loss.

Ethics approval

Approved 04/05/2017, Çukurova University Ethics Committee (Balcali, Adana, 01330, Turkey; +90(0)322 338 67 22; neclaetikkurul@gmail.com), ref: 65/4

Study design

Single-center double-blind randomized placebo-controlled phase II pilot study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

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 12 months, 2 capsules orally of either placebo (520 mg microcrystalline cellulose beadlets), 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). The trial starts with a screening visit and a wash-out period during which the use of peri-implantitis treatment is not permitted.

At the start of the study (baseline) a surgical flap will be made at all peri-implantitis sites to disinfect thoroughly with EDTA. Assessments will be done respectively at inclusion (baseline), and after 6 and 12 months of treatment.

Intervention type

Supplement

Phase

Drug names

Primary outcome measure

The probing pocket depth (PPD) is measured using a calibrated probe at 6 peri-implantitis sites at baseline and 12 months

Secondary outcome measures

1. The probing pocket depth (PPD) is measured using a calibrated probe at 6 peri-implantitis sites at baseline and 6 months
2. Bleeding on probing (BOP) is measured using a calibrated probe at 6 peri-implantitis sites at baseline, 6 and 12 months
3. Gingival recession (REC) is measured using a calibrated probe at 6 peri-implantitis sites at baseline, 6 and 12 months
4. Bone gain is measured with cone-beam computed tomography (CBCT) at baseline, 6 and 12 months
5. Biomarkers of bone formation and bone resorption are measured from samples taken at baseline, 6 and 12 months
6. Serum markers of inflammation (hs-CRP) are measured from serum samples taken at baseline, 6 and 12 months
7. Patient assessment of the impact of oral health measured using the Oral Health Impact Profile (OHIP)-14 questionnaire at baseline, 6 and 12 months

Overall trial start date

26/05/2016

Overall trial end date

11/01/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Peri-implantitis, defined as bone loss of more than 3 mm measured on intra-oral radiographs and a probing pocket depth (PPD) of more than 4 mm with bleeding on probing (BOP) or pus on probing
2. Patients with single and multiple osseointegrated implants
3. Aged between 18 and 75 years
4. Use of an approved form of birth control if at risk of pregnancy
5. Provide written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Total final enrolment

21

Participant exclusion criteria

1. Unable to understand the study procedures 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 (≤6 months prior to the start of the study)
7. Gingival index >2
8. Active, untreated periodontitis
9. Mobile implants (i.e. complete disintegration/loss of contact of the implant with the bone)
10. Patients with poorly controlled diabetes
11. Osteonecrosis of the jaw
12. Recent or current alcohol abuse and drug abuse
13. High-risk group for HIV
14. Clinically significant medical abnormalities which would make the subject unsuitable for the study as judged by the investigator
15. Renal failure, documented history of stroke, myocardial infarct, or cancer
16. Concomitant and previous medication
16.1. Less than 6 months between the treatment with systemic antibiotics and the start of the study
16.2. Concomitant and previous treatment with bisphosphonates
16.3. Concomitant treatment with local antiseptica i.e. rinsing solutions to disinfect the mouth (i.e. Hextril/Hexetidine, Corsodyl/chlorhexidine-digluconate)
16.4. 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

Recruitment start date

14/09/2017

Recruitment end date

15/01/2018

Locations

Countries of recruitment

Turkey

Trial participating centre

Cukurova University
Department of Periodontology Faculty of Dentistry
Adana
01330
Turkey

Sponsor information

Organisation

Bio Minerals NV

Sponsor details

Zenderstraat 12
Destelbergen
9070
Belgium
+32 (0) 9 228 20 00
sara.persyn@biominerals.be

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Bio Minerals NV

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.
Participants can contact the principal investigator to get access to their raw data and for discussion.

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/01/2021

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/06/2020: Trial’s existence confirmed by Çukurova University Ethics Committee.