Therapy of Peri-implantitis: Scaling Versus Low Abrasive Powder

Study Overview
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Brief Summary
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In the last decade, the number of dental implantations continuously increases. However, at the same time, the prevalence of peri-implantitis increases, too. Although both surgical and non-surgical interventions are available for the therapy, there is no efficient and satisfying therapy option resulting in an adequate improvement of this disease. An innovative, low abrasive powder has been introduced for the therapy of periodontitis. However, the powder might be suitable for the peri-implantitis therapy, also, and could improve the effectiveness of the therapy. The usage of this powder in peri-implantitis patients has not been assessed in a clinical trial although the effectiveness in natural teeth has been demonstrated. The aim of this prospective, randomised, multi-centre trial is to assess the effectiveness of the aforementioned powder in peri-implantitis patients.

Official Title
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A Randomized Multicenter Study in the Therapy of Periimplantitis: Scaling Versus Low Abrasive Powder

Conditions
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Peri-implantitis

Intervention / Treatment
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* Procedure: Air abrasion of the implant surface with a low abrasive powder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mild to moderate peri-implantitis age ≥18 years capacity to contract no subgingival debridement within the last six months informed consent Exclusion Criteria: pregnancy subgingival debridement within the last six months bleeding tendency usage of antibiotics within the last three months insufficient restorations (including caries etc.) Diabetes mellitus smoker implantats with platform switch

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low-abrasive powder<br> | Procedure: Air abrasion of the implant surface with a low abrasive powder<br>* Test treatment will be performed using the low abrasive powder in a standard air-polishing unit, which will be set up according to the manufacturer's instructions. The unit will be set to a medium water and powder setting, and the powder chamber will be filled to the indicated maximum powder level before treatment to ensure reproducible treatment conditions. The jet will be directed to the periodontal pocket for 5 s per surface (vestibular, lingual, mesio and distal) for subgingival plaque removal.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket probing depth |  | Twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of pain levels |  | One week and six months | 
| Assessment of the oral health related quality of life using the OHIP (14) |  | One , three, six and twelve months |