Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing

Study Overview
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Brief Summary
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Erythritol is a natural sugar alcohol (a four-carbon polyol) produced by the reduction of erythrose. It is considered safe as food additive and has many of the functional properties that are important for subgingival debridement. Current evidence includes no prospective studies comparing the outcomes of a low abrasive erythritol air-polishing as an adjunctive therapy to conventional titanium and ultrasonic debridement of patients in a maintenance program with peri-implantitis. Thus, the main purpose of this randomized, single-masked controlled trial (RCT) is to assess whether low abrasive erythritol air-polishing has an adjunct effect to conventional non-surgical treatment of peri-implantitis.

Detailed Description
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This RCT will enroll subjects among patients in need for non-surgical treatment of peri-implantitis at a private dental clinic in Stavanger, Norway. Forty patients diagnosed with peri-implantitis on at least one implant will be randomly allocated by tossing a coin into test or control group. Patients with cement-retained and screw-retained supraconstructions will be included. Treatment of peri-implantitis will be performed by one operator (AS) at baseline, 3-, 6-, 9- and 12-month follow-up visits. Local anesthesia will be used when needed. In the test group, implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit. In the control group, implant with peri-implantitis will be debrided with titanium curette and ultrasonic device only. Test and control debridement will be performed without time limit. The treatment will continue until the operator is judging the implant surface to be free for supra- and subgingival deposits.

Official Title
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Non-surgical Treatment of Peri-implantitis With and Without Erythritol Air-polishing: A 12-month Randomized Controlled Trial

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Procedure: Titanium curette.
* Procedure: Ultrasonic
* Procedure: Air-polishing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy subjects aged 20 - 85 years who have received one or more dental implant(s) being in successful function for more than 12 months and restored with an optimal supraconstruction Diagnosed with peri-implantitis based on the following criteria: Bleeding and/or suppuration upon gentle probing Increased probing depths (PD) compared with previous examinations or PD of ≥ 4 mm in at least one site around the implant Crestal bone level (CBL) loss ≥2 mm compared with baseline registration Exclusion Criteria: Surgical treatment of peri-implantitis the last 6 months Supportive periodontal therapy within 3 months Use of systemic antibiotic within 6 months A history of non-compliant behavior Inflammation around implant without evidence of bone loss Periapical peri-implantitis Subjects with implant fracture, ceramic implants, or detectable subgingival cement Any current medical condition affecting the use of the abrasive air-polishing device. Subjects with diabetes mellitus, cancer, HIV/aids, acute infections, liver or kidney dysfunction/failure, Current pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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
Interventional Model Description: Randomized, single-masked controlled trial (RCT)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Titanium curette and ultrasonic.<br>Control implants will be debrided with titanium curette and ultrasonic device without time limit. | Procedure: Titanium curette.<br>* Implant debridement.<br>Procedure: Ultrasonic<br>* Implant debridement.<br>* Other names: Ultrasonic device;|
| Experimental: Titanium curette, ultrasonic and air-polishing.<br>Test implants will be treated with titanium curette, ultrasonic device and a specially designed nozzle mounted on a hand piece (Perio-Flow) connected to an airflow unit also without time limit. | Procedure: Titanium curette.<br>* Implant debridement.<br>Procedure: Ultrasonic<br>* Implant debridement.<br>* Other names: Ultrasonic device;Procedure: Air-polishing<br>* Implant debridement and polishing.<br>* Other names: Air-polishing device;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in probing depth (PD) | PD as the distance in mm from the implant mucosal margin to the probable base of the pocket at six sites; | 12 moths | 
| Crestal bone level (CBL) | Intraoral digitalized radiographs will be taken with customized Eggen-holder and long cone, parallel technique to assess CBL. The distance from implant platform to the mesial and distal bone levels will be measured by using the software program DIGORA (Soredex, Helsinki). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing (BoP) | BoP as the presence of bleeding after gentle probing (Renvert et al. 2017). | 12 months | 
| Gingival crevicular fluid (GCF) | Sample sites will be isolated with cottons rolls, carefully cleaned for supragingival plaque and air-dried. A perio paper strip will then be gently placed one to two mm into the entrance of the pocket and left in place for 30 seconds. | 12 months | 
| Visual analogue scale (VAS) | The scorings will be performed following completion of the debridement at baseline and at 6 and 12 months with 0 = no pain and 100 = worst pain I can imagine. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-implantitis, Air-polishing, Erythritol