Condition category
Oral Health
Date applied
17/02/2020
Date assigned
20/02/2020
Last edited
06/03/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Angeliki Polymeri

ORCID ID

https://orcid.org/0000-0002-5583-0365

Contact details

Department of Periodontology
ACTA
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
+31205980322
a.polymeri@acta.nl

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NL51525.029.15

Study information

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

Acronym

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

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

Study design

Randomized controlled single-blinded prospective clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files (in Dutch)

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

Phase

Drug names

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 trial start date

01/04/2013

Overall trial end date

16/05/2019

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

40

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

Trial participating centre

Academic Centre for Dentistry Amsterdam (ACTA),
Department of Periodontology University of Amsterdam and Vrije Universiteit Gustav Mahlerlaan 3004
Amsterdam
1081LA
Netherlands

Sponsor information

Organisation

Academic Center for Dentistry Amsterdam

Sponsor details

University of Amsterdam and Vrije Universiteit Amsterdam
Gustav Mahlerlaan 3004
Amsterdam
1081 LA
Netherlands
+31 205980322
paro@acta.nl

Sponsor type

University/education

Website

https://www.acta.nl

Funders

Funder type

University/education

Funder name

Academic Centre for Dentistry Amsterdam (ACTA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

ZimmerBioMet

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.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

31/05/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

06/03/2020: The participant information sheet has been uploaded. 19/02/2020: Trial’s existence confirmed by VU Medical Centre, Amsterdam.