Regenerative surgical treatment of peri-implantosseous defects - a multicenter randomized prospective clinical study

Phase 3

Completed

Conditions: 10044018
infection of toothimplant surrounding tissues
Peri-implantitis
10019815
10005944

Registration Number: NL-OMON36465

Lead Sponsor: Academisch Centrum voor Tandheelkunde Amsterdam (ACTA)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

The patient should have;
* A peri-implant intraosseous defect with at least 3 mm defect depth as seen on an intraoral radiograph.
* Clinically a probing depth * 5 mm combined with bleeding and/or pus should be present at the site.
* During surgical exploration an intraosseous 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).
Implants included in the study must have been in function for more than 12 months.
Note: If the same patient has more than one defect meeting the inclusion criteria only one such defects will be included in the study. Other defects will be treated according the standard protocol.

Exclusion Criteria

Main exclusion criteria:
* Subjects with diabetes mellitus (HbA1c >6.5)
* Subjects taking corticosteroids or other anti-inflammatory prescription drugs
* Subjects taking medications known to induce gingival hyperplasia
* Subjects must not be allergic to penicillin
* 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 /bone substitute or other type of regenerative material
* Implants previously treated for peri-implantitis
* If stability of the titanium granules cannot be accomplished in the defect
* Failure of obtaining soft tissue closure
* Mobile implants

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main aim is to show a mean difference in change in FILL (bone regeneration<br /><br>of peri-implant osseous defects) in patients treated with titanium granules<br /><br>compared with patients treated with sham at 12 months. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Analysis of secondary endpoints<br /><br>The secondary parameters to be analysed are:<br /><br><br /><br>1) change in clinical parameters (PPD, BoP, PUS )<br /><br>2) change in subclinical parameters (radiographic defect resolution)<br /><br>3) change in microbial composion of the peri-implant sulcus<br /><br>before and after treatment<br /><br>4) in vitro cytokine production of fibroblasts of peri-implant origin<br /><br>(discarded during the operation) in response to pathogens (especially P.<br /><br>gingivalis). Response of the fibroblasts from patient colonozed with P.<br /><br>gingivalis will be compared with the response of the cells from the patients<br /><br>not colonized with<br /><br>P. gingivalis.<br /><br>5) To evaluate soft parameters such as patients subjective satisfaction.<br /><br>6) Aesthetics<br /><br></p><br>