Our main objective is to evaluate and compare appliance of Endobon® Xenograft Granules (Biomet 3i) with an established bovine derived bone mineral for regeneration of intra-bony peri-implantitis defects.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
infecties rondom tand implantaten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is radiographic vertical reduction of the intra-bony
peri-implantitis defects for test and control groups at 6 and 12 months after
surgery. The difference in defect fill will be measured on the basis of
standardized intra-oral periapical radiographs taken with individualized
holders at baseline, and 6 and 12 months after surgery.
Secondary outcome
The secondary objectives to evaluate are:
1) clinical parameters (pocket probing depth [PPD], clinical attachment level
[CAL] from stent margin, bleeding on probing, presence /absence pus)
2) patient centered outcomes (subjective satisfaction)
3) graft morbidity
4) esthetics
Background summary
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.
For peri-implantitis intra-bony defects, bone substitutes may give additional
implant support and stability. We hypothesize that the peri-implantitis
patients treated with Endobon® Xenograft Granules (Biomet 3i) will regenerate
more new bone around dental implants than the established bovine derived bone
mineral.
Study objective
Our main objective is to evaluate and compare appliance of Endobon® Xenograft
Granules (Biomet 3i) with an established bovine derived bone mineral for
regeneration of intra-bony peri-implantitis defects.
Study design
This is a randomized controlled prospective, clinical trial of 12 months
follow-up at the Sections of Periodontology and Oral Implantology of the
Academic Center for Dentistry Amsterdam (ACTA).
Intervention
We will treat 20 test patients with Endobon® Xenograft Granules using a
"non-submerged" regenerative surgical approach according to the specified
procedure, and 20 control patients treated similarly with an established bovine
derived bone mineral.
Study burden and risks
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.
Gustav Mahlerlaan 3004
Amsterdam 1081LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081LA
NL
Listed location countries
Age
Inclusion criteria
• During surgical exploration an intra-bony component of at least 3 mm at the deepest point must be present.
• 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.
• The defect must not be wider than 4 mm and the defect angle must be less than 35 degrees from axis of implant.
Exclusion criteria
• Subjects with diabetes mellitus (HbAlc >= 6.5%)
• Subjects taking corticosteroids or other anti-inflammatory prescription drug
• Subjects taking medications known to induce gingival hyperplasia
• Subjects must not be allergic to penicillin or metronidazole
• Subjects with a history of taking systemic antibiotics in the preceding month
• Subjects must not be pregnant or lactating
• Implants placed in grafted bone or previously augmented with bone substitute or other type of regenerative material
• If stability of the Endobon® granules or control granules cannot be accomplished in the defect
• Failure of obtaining soft tissue closure
• Mobile implants
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51525.029.15 |