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Peri-implantitis is defined as inflammation in the mucosa surrounding an oral implant with loss of supporting bone. The goals of peri-implantitis treatment are to resolve inflammation and to arrest the progression of disease. It is important to systematically gather information on the effect of surgical peri-implant treatment and to assess different protocols regarding chair-side maintenance of peri-implant tissue after surgery
The aims of this clinical investigation are to evaluate the clinical, microbiological and radiographic outcomes of surgical treatment of peri-implantitis and to evaluate the efficacy of 2 supportive treatment protocols based on the use of titanium cyrettes or by the use of a flexible, biodegradable chitosan brush. Furthermore, to evaluate the impact of this therapy on selected biochemical markers associated with chronic inflammation and bone tissue destruction.
Little is known about the effect of chair-side maintenance of dental implants after peri-implantitits surgery. Traditionally, the maintenance has been performed by titanium curettes to remove microbiological deposits from the submucosal area.
The Labrida biodegradable brush is a novel debridement device intended for use on dental implants. The concept of using a biodegradable material is related to the suggested problems with leaving remnants on the treated implant surface which would be negative from a bone regenerative aspect. The use of a flexible brush relates to the access problems when treating dental implants both related to the threads as well as due to the prosthetic supra construction hindering access for debridement with regular instruments developed for teeth. The material used in the brush will be Chitosan which is a natural polysaccharide, chitosan (poly-N-acetyl glucosaminoglycan), which is a nontoxic and bioabsorbable (REK-approval 2012/791 polymer).
H0: It is possible to maintain peri-implant health after surgical peri-implantitis treatment. There is no short- or long term clinical or radiographical differences between patients surgically treated for peri-implantitis maintained by the use of titanium cyrettes or with the Labrida brush in chair-side supportive care
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes |
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| Control | Active Comparator | Treatment/maintenance of implants postsurgically performed by the use of titanium curettes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chitosan brush | Device | If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation control | Absence/presence of bleeding on probing and deep peri-implant pockets | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive bone loss | Loss of attachment at the implant identified on radiographs | 3 months |
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Inclusion Criteria:
Overt peri-implantitis presenting at least one implant with;
Main exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Odd Carsten Koldsland, Ph.D | Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo | Principal Investigator |
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Data will be handeled by the investigators treating the patients and collecting data
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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6 month after surgical intervention, the population is randomly assigned to two parallel groups, receiving one of two maintenance programs - use of titanium curettes or chitosan brushes. Randomization was performed by pulling notes test/control.
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Maintenance treatment (test/control) was performed after the investigator left the room. Investigator did not have access to the registration forms where information regarding assignment (test/control) was noted
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