Peri-implantitis Implantoplasty Treatment

Study Overview
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Brief Summary
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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.

Official Title
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Surgical Peri-implantitis Treatment With and Without Implantoplasty

Conditions
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Peri-Implantitis, Peri-implant Mucositis

Intervention / Treatment
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* Procedure: Implantoplasty
* Procedure: Open flap debridement alone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peri-implantitis treatment with implantoplasty<br>Open flap debridement with implantoplasty treatment | Procedure: Implantoplasty<br>* 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.<br>Procedure: Open flap debridement alone<br>* Open flap debridement alone<br>|
| Active Comparator: Peri-implantitis treatment without implantoplasty<br>Open flap debridement withput implantoplasty treatment | Procedure: Implantoplasty<br>* 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.<br>Procedure: Open flap debridement alone<br>* Open flap debridement alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |