Peri-implant Mucositis Clinical Trial
Official title:
The Effect of Peri-implant Surgery and Chair-side Supportive Post Surgical Peri-implant Therapy
Verified date | April 2021 |
Source | University of Oslo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | April 28, 2021 |
Est. primary completion date | December 9, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: Overt peri-implantitis presenting at least one implant with; - radiographic bone loss = 2.0 mm - bleeding on probing (BoP) Main exclusion criteria: - radiotherapy - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Oslo |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammation control | Absence/presence of bleeding on probing and deep peri-implant pockets | 3 months | |
Secondary | Progressive bone loss | Loss of attachment at the implant identified on radiographs | 3 months |
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