The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
NCT ID: NCT03421717
Last Updated: 2021-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
46 participants
INTERVENTIONAL
2012-11-01
2021-04-28
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Test
Treatment/maintenance of implants postsurgically performed by the use of chitosan brushes
Chitosan brush
If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation
Control
Treatment/maintenance of implants postsurgically performed by the use of titanium curettes
Chitosan brush
If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation
Interventions
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Chitosan brush
If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* radiographic bone loss ≥ 2.0 mm
* bleeding on probing (BoP)
Exclusion Criteria
* chemotherapy
* systemic long-term corticosteroid treatment
* pregnancy or nursing
* anatomical abnormalities
* history of previous treatment of peri-implantitis within 6 months after the screening
* American Society of Anesthesiologists (ASA) classification for assessing the fitness of patients before surgery \> 2
ALL
No
Sponsors
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University of Oslo
OTHER
Responsible Party
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Odd Carsten Koldsland
Associate professor
Principal Investigators
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Odd Carsten Koldsland, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Institute of Clinical Odontology, Faculty of Dentistry, University of Oslo
Other Identifiers
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Peri-implantitis
Identifier Type: -
Identifier Source: org_study_id
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