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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peri-implantitis treatment with implantoplasty | Experimental | Open flap debridement with implantoplasty treatment |
|
| Peri-implantitis treatment without implantoplasty | Active Comparator | Open flap debridement withput implantoplasty treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantoplasty | Procedure | Implantoplasty is the mechanical smoothening of rough titanium implants as part of the surgical treatment of peri-implantitis. Treatment is thought to facilitate self-performed oral hygiene. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding on probing | Measured with a periodontal probe | 12 months after treatment |
| Bleeding on probing | Measured with a periodontal probe | 24 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Suppuration | Visible suppuration upon probing the implant with a periodontal probe | 12 months after treatment |
| Suppuration | Visible suppuration upon probing the implant with a periodontal probe |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo | Recruiting | Oslo | Oslo | 0455 | Norway |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Open flap debridement alone | Procedure | Open flap debridement alone |
|
| 24 months after treatment |
| Pocket probing depth | Measured with a periodontal probe | 12 months after treatment |
| Pocket probing depth | Measured with a periodontal probe | 24 months after treatment |
| 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 |
| Clinical attachment loss measurements | Measured with a periodontal probe | 12 months after treatment |
| Clinical attachment loss measurements | Measured with a periodontal probe | 24 months after treatment |
| Radiographic bone loss | Measured on standardized radiograps | 12 months after treatment |
| Radiographic bone loss | Measured on standardized radiograps | 24 months after treatment |
| Implant fracture | Clinical examination to assess whether implants have fractured following treatment | 24 months |
| Institute of Clinical Dentistry, University of Oslo, Norway | Recruiting | Oslo | Norway |
|