Non-surgical Treatment of Peri-implant Mucositis: FMUD vs FMUD and Air-Flow Master Piezon®

Study Overview
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Brief Summary
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The aim of the present study is to evaluate the adjunctive effect of glycine-powder air-polishing (GPAP) to full-mouth ultrasonic debridement (Fm-UD) in the treatment of peri-implant mucositis, and to determine the predictive role of implant and patient-level variables for disease resolution. Both treatments are described in the literature, but few studies are available on their comparison.

Detailed Description
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52 patients (132 implants) with peri-implant mucositis were included in this randomized parallel arm clinical study. Following baseline variables assessment, participants received Fm-UD. Implants allocated to the test group (n=64) were additionally treated with GPAP. Clinical outcomes were evaluated at 3 and 12 months following intervention. Complete and partial disease resolution were defined as absence of BoP (DR1) or <2 BoP+ sites (DR2), respectively.

Official Title
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Treatment of Peri-implant Mucositis: Adjunctive Benefit of Glycine Powder Air Polishing Device to Professional Mechanical Biofilm Removal. A Randomized Parallel Arm Clinical Study

Conditions
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Peri-implant Mucositis

Intervention / Treatment
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* Device: Glycine powder air polishing
* Device: Full mouth ultrasonic debridement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age between 18 and 70 years old; presence of one implant loaded at least one year before; bleeding on probing and/or suppuration of the peri-implant mucosa; pain and/or tenderness of the peri-implant mucosa; good general health conditions. Exclusion Criteria: radiographic bone loss ≥ 2mm; intake of anticoagulants, antiplatelet, antibiotic or cortisone drugs; inability to perform oral hygiene maneuvers.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Full mouth ultrasonic debridement plus glycine powder air polishing<br>Plaque and calculus are firstly removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant). After this procedure an air polishing device (Air-flow Master Piezon®) is used as additional therapy to further debride peri-implant trans-mucosal tract. | Device: Glycine powder air polishing<br>* Peri-implant mucositis sites treated with a glycine powder air polishing device (Air-Flow Master Piezon®).<br>Device: Full mouth ultrasonic debridement<br>* Peri-implant mucositis sites are treated with thin ultrasonic tips.<br>|
| Active Comparator: Full mouth ultrasonic debridement<br>Plaque and calculus are removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant). | Device: Full mouth ultrasonic debridement<br>* Peri-implant mucositis sites are treated with thin ultrasonic tips.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding on probing | After probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing pocket depth change | Change in probing pocket depth measured in millimeter through a periodontal probe. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-implant Mucosits, air polishing device, non-surgical treatment