Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is: • Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments? Participants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise. Researchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.

Official Title
-----------------
Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis: Mechanical Debridement vs. Air-polishing

Conditions
-----------------
Peri-Implantitis

Intervention / Treatment
-----------------
* Procedure: Non-surgical treatment of peri-implantitis with mechanical debridement
* Procedure: Non-surgical treatment of peri-implantitis with air polishing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting. Exclusion Criteria: Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Each participant will be randomized to non-surgical treatment of peri-implantitits with either mechanical debridement or with air-polishing.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mechanical debridement<br> | Procedure: Non-surgical treatment of peri-implantitis with mechanical debridement<br>* Non-surgical treatment of peri-implantitis with mechanical debridement .<br>|
| Experimental: Air polishing<br> | Procedure: Non-surgical treatment of peri-implantitis with air polishing<br>* Non-surgical treatment of peri-implantitis with air polishing<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | Probing depth 5 millimeters or more | 26 weeks | 
| Bleeding on probing | Bleeding from pocket on pocket depth probing | 26 weeks | 
| Suppuration on probing | Suppuration from pocket on pocket depth probing | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peri-implantitis, Non-surgical treatment, Air-polishing, Mechanical debridement, Bleeding on probing, periodontal pocket depth