Calcium phosphate granules in treatment of peri-implantitis
| ISRCTN | ISRCTN13514478 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13514478 |
| Secondary identifying numbers | 2013/02 |
- Submission date
- 05/10/2018
- Registration date
- 24/10/2018
- Last edited
- 26/11/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
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
Contact information
Scientific
Dzirciema street 20
Riga
LV 1007
Latvia
Study information
| Study design | Interventional single-centre non-randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| 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 |
| Study objectives | Implantation of biphasic calcium phosphate (HAP/βTCP) granules around dental implants in patients with peri-implantitis will stimulate regeneration of hard tissue. |
| Ethics approval(s) | Riga Stradiņš University Commission of Ethics, 04/09/2014, Nr. E-9(2)/24.07.2014 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/09/2012 |
| Completion date | 30/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 patients |
| Key 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 |
| Key exclusion criteria | N/A |
| Date of first enrolment | 01/02/2013 |
| Date of final enrolment | 01/05/2013 |
Locations
Countries of recruitment
- Latvia
Study participating centre
Riga
LV 1007
Latvia
Sponsor information
University/education
Dzirciema Street 16
Riga
LV 1007
Latvia
| Phone | +37167409258 |
|---|---|
| zd@rsu.lv | |
| Website | www.rsu.lv |
"ROR" |
https://ror.org/03nadks56 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 20/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | We intend to publish the main results of the radiological investigation Journal of Healthcare Engineering in 2018 |
| IPD sharing plan | Participant data will be available upon request from Vadims Klimecs (vadims.klimecs@gmail.com) in accordance with General Data Protection Regulation (GDPR). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/12/2018 | 06/11/2019 | Yes | No |
Editorial Notes
26/11/2019: Internal review.
06/11/2019: Publication reference added.
02/11/2018: Internal review.
