Condition category
Oral Health
Date applied
05/10/2018
Date assigned
24/10/2018
Last edited
02/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Implant based treatment is an important part of modern dentistry. Loss of bone around dental implants can happen in 5–10% of patients. Peri-implantitis is an infection that causes bone loss around a dental implant. The optimal result of peri-implantitis treatment is regeneration of hard and soft tissues supporting the dental implant. The aim of study is to analyse the results of peri-implantitis treatment, where in addition to the classical surgical treatment, the bone defect around the dental implant was filled with bioceramic granules developed and produced by Riga Technical University (RTU), Rudolfs Cimdins Riga Biomaterials Innovation and Development Centre.

Who can participate?
Adults with peri-implantitis

What does the study involve?
All participants receive the same treatment - mechanical cleaning of the implant surface and filling of bone defect with bioceramic granules. All patients will have a radiological investigation before the treatment and at least five years after the treatment.

What are the possible benefits and risks of taking part in this study?
From enrolling in this study, the participants get complex treatment with the use of new biomaterials, which may better treat their peri-implantitis. There are no known risks to participants taking party in this study.

Where is the study run from?
Riga Stradiņš University Institute of Stomatology (Latvia)

When is the study starting and how long is it expected to run for?
September 2012 to May 2018

Who is funding the study?
1. Riga Stradiņš University (Latvia)
2. National Research Programme No 2014.10-4/VPP-3/21 ‘Multifunctional Materials and Composites, Photonics and Nanotechnology (IMIS2)’ Project No 4 “Nanomaterials and Nanotechnologies for Medical Applications” (Latvia)

Who is the main contact?
Vadims Klimecs
vadims.klimecs@gmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Mr Vadims Klimecs

ORCID ID

Contact details

Dzirciema street 20
Riga
LV 1007
Latvia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2013/02

Study information

Scientific title

Radiological evaluation with 3D cone-beam computed tomography of bone loss around dental implants in 18 patients 5 years after implantation of biphasic calcium phosphate (HAP/βTCP) granules

Acronym

Study hypothesis

Implantation of biphasic calcium phosphate (HAP/βTCP) granules around dental implants in patients with peri-implantitis will stimulate regeneration of hard tissue.

Ethics approval

Riga Stradiņš University Commission of Ethics, 04/09/2014, Nr. E-9(2)/24.07.2014

Study design

Interventional single-centre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Bone loss around dental implants - peri-implantitis

Intervention

Patients underwent treatment by the following surgical protocol:
1. Systemic antibiotics 3 times per day for 2 days before surgery
2. Preoperative rinse for 1 minute with a 0.2% chlorhexidine solution
3. Local anaesthesia with Articaine solution
4. Designing of mucoperiostal flap
5. Determining the size of the infected area
6. Mechanical cleaning and curettage of the implant surface
7. Application of a gauze pad moistened with a 2% chlorhexidine solution in the area of bone defect for 5 minutes
8. After removing the gauze swab, the defect is washed by 1 g of tetracycline dissolved in 20 ml of sterile physiological solution
9. Filling of bone defect with bioactive material - HAp/β-TCP
10. Wound closure with a surgical suture
11. Systemic antibiotics 3 times per day for 3 days after surgery
The treatment will last for one operation and there will be a 5 year follow-up period.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Alveolar bone density, assessed using 3D CT scans before the operation and 5 years after the operation

Secondary outcome measures

Percentage of bone tissue loss, assessed using 3D CT scans before the operation and 5 years after the operation

Overall trial start date

01/09/2012

Overall trial end date

30/05/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Peri-implantitis at any stage
2. Use of biphasic calcium phosphate (HAP/βTCP) granules produced in Riga Technical University Rudolfs Cimdins Riga Biomaterials Innovation and Development Centre
3. Presence of a 3D CT before the treatment
4. Aged 40-71 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 patients

Participant exclusion criteria

N/A

Recruitment start date

01/02/2013

Recruitment end date

01/05/2013

Locations

Countries of recruitment

Latvia

Trial participating centre

Riga Stradins University Institute of Stomatology
Dzirciema Street 20
Riga
LV 1007
Latvia

Sponsor information

Organisation

Riga Stradiņš University

Sponsor details

Dzirciema Street 16
Riga
LV 1007
Latvia
+37167409258
zd@rsu.lv

Sponsor type

University/education

Website

www.rsu.lv

Funders

Funder type

University/education

Funder name

Riga Stradiņš University

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National Research Programme No 2014.10-4/VPP-3/21 ‘Multifunctional Materials and Composites, Photonics and Nanotechnology (IMIS2)’ Project No 4 ‘Nanomaterials and Nanotechnologies for Medical Applications’.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to publish the main results of the radiological investigation Journal of Healthcare Engineering in 2018

IPD sharing statement:
Participant data will be available upon request from Vadims Klimecs (vadims.klimecs@gmail.com) in accordance with General Data Protection Regulation (GDPR).

Intention to publish date

20/12/2018

Participant level data

Available on request

Basic results (scientific)

Patients at least 5 years follow-up show good clinical results, which are further confirmed by 3D CT.
To simplify the assessment of the quality of the treatment using the costuming agent based on calcium hydroxyapatite, the percentage of bone tissue loss (the depth of the bone pocket) was taken with respect to the body of the dental implant before and after therapy. In average bone pocket depth was 34.6% +/- 5.4% of the dental implant length and it decreased to 22.3%+/-3.4% after regenerative surgery.
In conformity with Froum classification of peri-implantitis before the treatment, the second stage was revealed in three cases, and the third stage in 15 cases. After treatment, the first stage was in 10 cases, and the second stage in 8 cases. In conformity of Ata-Ali classification of peri-implantitis the second stage was in one case, the third stage in 3 cases and the fourth stage in 14 cases, after treatment the first stage was in 7 cases, and the second stage in 11 cases.

Publication list

Publication citations

Additional files

Editorial Notes

02/11/2018: Internal review.