Surgery of failing dental implants using two different brands of bovine bone chips
| ISRCTN | ISRCTN14347002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14347002 |
| Secondary identifying numbers | NL51525.029.15 |
- Submission date
- 17/02/2020
- Registration date
- 20/02/2020
- Last edited
- 14/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Peri-implantitis is an inflammatory and infectious disease of the supporting soft and hard tissues around a dental implant, characterized by bleeding and/or suppuration on probing and crestal bone loss. Due to the progressive nature of the inflammatory process rapid loss of supporting bone, impaired oral function and even implant loss can occur. Prevalence of peri-implantitis on patient level is high, varying from 16% up to 56% depending on the threshold set for disease definition.
Who can participate?
Adults with peri-implantitis.
What does the study involve?
Participants will be randomly allocated to receive treatment with Endobon® Xenograft Granules using a "non-submerged" regenerative surgical approach according to the specified procedure, or similar treatment with an established bovine derived bone mineral.
What are the possible benefits and risks of participating?
If the treatment is successful, the implant can be saved; new bone will be regenerated and the implant will have enhanced bone support. The bone substitutes are free of cost for the patient. The risks associated with taking part in this clinical study are no greater than with ordinary gum surgery (flap operation). There may be some bleeding, pain and swelling for the first few days after the procedure. There is also a risk that the bone substitutes will not anchor sufficiently. If this happens the material will be removed and ordinary flap operation will take place without any extra costs for the patient.
Where is the study run from?
Department of Periodontology, Academic Centre for Dentistry Amsterdam (ACTA) (Netherlands)
When is the study starting and how long is it expected to run for?
July 2015 to May 2019
Who is funding the study?
1. Department of Periodontology ACTA (Netherlands)
2. ZimmerBioMet (USA)
Who is the main contact?
Dr Angeliki Polymeri
a.polymeri@acta.nl
Contact information
Scientific
Department of Periodontology, ACTA
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
 ORCID ID |
0000-0002-5583-0365 |
|---|---|
| Phone | +31205980322 |
| a.polymeri@acta.nl |
Study information
| Study design | Randomized controlled single-blinded prospective clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN14347002_PIS_10Feb2015.pdf |
| Scientific title | The regenerative surgical treatment of intra-bony peri-implantitis defects with Endobon® (test) versus an established bovine derived bone mineral (control) – a pilot study |
| Study hypothesis | The peri-implantitis patients treated with Endobon® Xenograft Granules (Biomet 3i) will perform non-inferior in new bone formation around dental implants than the established bovine-derived bone mineral (Bio-Oss®) |
| Ethics approval(s) | Approved 29/07/2015, Ethical committee of the VU Medical Centre, Amsterdam (Medisch Ethische Toetsingscommissie, VU Medisch Centrum, Postal address: Postbus 7057, 1007 MB Amsterdam the Netherlands; +31204445585; e-mail: metc@vumc.nl), ref: NL51525.029.15 |
| Condition | Peri-implantitis |
| Intervention | Test patients are treated with Endobon® Xenograft Granules using a "non-submerged" regenerative surgical approach according to the specified procedure, and control patients treated similarly with an established bovine derived bone mineral. The study will be randomized using block design which will insure that the number of subjects receiving the different treatments is randomly and evenly allocated. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Vertical radiographic bone fill of peri-implant intra-bony defects measured on the basis of standardized intraoral periapical radiographs at at baseline, 6 months and 12 months |
| Secondary outcome measures | All measured at 6 sites/implant at baseline, 6 months and 12 months: 1. Pocket probing depth 2. Bleeding on probing 3. Dichotomous scoring of suppuration (pus) 4. Dichotomous scoring of plaque |
| Overall study start date | 01/04/2013 |
| Overall study end date | 16/05/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 |
| Total final enrolment | 25 |
| Participant inclusion criteria | 1. During surgical exploration an intra-bony component of at least 3 mm at the deepest point must be present. 2. The defect should have a minimum of 3 osseous walls (a circumference of the osseous defect of at least 270 degrees). Only 3 and 4 wall intraosseous defects will be included 3. The defect must not be wider than 4 mm and the defect angle must be less than 35 degrees from axis of implant Note: If the same patient has more than one defect meeting the inclusion criteria only one such defect will be included in the study and the other defects will be treated with standard open flap debridement |
| Participant exclusion criteria | 1. Diabetes mellitus (HbAlc ≥ 6.5%) 2. Taking corticosteroids or other anti-inflammatory prescription drug 3. Taking medications known to induce gingival hyperplasia 4. Allergic to penicillin or metronidazole 5. History of taking systemic antibiotics in the preceding month 6. Pregnant or lactating 7. Stability of the Endobon® granules or control granules cannot be accomplished in the defect 8. Failure of obtaining soft tissue closure 9. Mobile implants |
| Recruitment start date | 29/07/2015 |
| Recruitment end date | 07/06/2018 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University of Amsterdam and Vrije Universiteit
Gustav Mahlerlaan 3004
Amsterdam
1081LA
Netherlands
Sponsor information
University/education
University of Amsterdam and Vrije Universiteit Amsterdam
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
| Phone | +31 205980322 |
|---|---|
| paro@acta.nl | |
| Website | https://www.acta.nl |
"ROR" |
https://ror.org/04x5wnb75 |
Funders
Funder type
University/education
No information available
No information available
Results and Publications
| Intention to publish date | 31/05/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | 10/02/2015 | 06/03/2020 | No | Yes | |
| Results article | results | 01/11/2020 | 11/09/2020 | Yes | No |
Additional files
- ISRCTN14347002_PIS_10Feb2015.pdf
- Uploaded 06/03/2020
Editorial Notes
14/09/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
06/03/2020: The participant information sheet has been uploaded.
19/02/2020: Trial’s existence confirmed by VU Medical Centre, Amsterdam.
