Peri-Implantitis Clinical Trial
Official title:
Surgical Peri-implantitis Treatment With and Without Implantoplasty
Verified date | November 2023 |
Source | University of Oslo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This double arm, split-mouth, single centre, controlled, randomised clinical study is designed to examine the effect of implantoplasty in treatment of peri-implantitis. Peri-implantitis will be treated with open flap debridement, with or without implantoplasty.
Status | Recruiting |
Enrollment | 35 |
Est. completion date | June 15, 2027 |
Est. primary completion date | June 15, 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Peri-implantitis (according to 2018 criteria) on minimum 2 implants of similar surface and defect type - Competent to give consent - Exposed, modified implant surface with loss >2mm Exclusion Criteria: - Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment - Present or past use of bisphosphonate treatment • Pregnant or nursing subjects - Patients classified as > class II according to ASA classification - Implant unavailable for implantoplasty treatment - Inhability to comprehend and respond to the quality of life questionnaire - Examiners/operators deem original placement of implant (angle, position) suboptimal and considered to play a major role in development of peri-implantitis - History of peri-implantitis surgery prior to 6 months of screening |
Country | Name | City | State |
---|---|---|---|
Norway | Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo | Oslo | |
Norway | Institute of Clinical Dentistry, University of Oslo, Norway | Oslo |
Lead Sponsor | Collaborator |
---|---|
University of Oslo |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bleeding on probing | Measured with a periodontal probe | 12 months after treatment | |
Primary | Bleeding on probing | Measured with a periodontal probe | 24 months after treatment | |
Secondary | Suppuration | Visible suppuration upon probing the implant with a periodontal probe | 12 months after treatment | |
Secondary | Suppuration | Visible suppuration upon probing the implant with a periodontal probe | 24 months after treatment | |
Secondary | Pocket probing depth | Measured with a periodontal probe | 12 months after treatment | |
Secondary | Pocket probing depth | Measured with a periodontal probe | 24 months after treatment | |
Secondary | Changes in patient-reported quality of life (QoL) | To assess QoL changes related to mouth and teeth prior to therapy to after therapy by the use of "The Oral Impacts on Daily Performance (OIDP)" instrument. Each question is assessed by a 5-point scale; (1) never affected; (2) less than once a month; (3) once or twice a month; (4) once or twice a week; and (5) every or nearly every day. The higher number represents more severe impact on quality of life; e.g. worse outcome.
Each item will be dichotomised yielding the categories (A) affected; including scale categories (2)-(5), and (B) unaffected; including category (1) |
Preoperatively compared to 24 months after treatment | |
Secondary | Clinical attachment loss measurements | Measured with a periodontal probe | 12 months after treatment | |
Secondary | Clinical attachment loss measurements | Measured with a periodontal probe | 24 months after treatment | |
Secondary | Radiographic bone loss | Measured on standardized radiograps | 12 months after treatment | |
Secondary | Radiographic bone loss | Measured on standardized radiograps | 24 months after treatment | |
Secondary | Implant fracture | Clinical examination to assess whether implants have fractured following treatment | 24 months |
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