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
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
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
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30631412 (added 06/11/2019)