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

Not Applicable

Completed

• Conditions: Peri-implant Mucositis
• Interventions: Device: Glycine powder air polishing; Device: Full mouth ultrasonic debridement

• Registration Number: NCT05801315
• Lead Sponsor: University of Siena

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-03-04
• Primary Completion: 2023-03-20
• Study Completion: 2023-03-20
• Study First Submitted QC: 2023-03-23
• Study First Posted: 2023-04-06
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-25
• Last Update Posted: 2023-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full mouth ultrasonic debridement plus glycine powder air polishing	Full mouth ultrasonic debridement	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.
Full mouth ultrasonic debridement plus glycine powder air polishing	Glycine powder air polishing	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.
Full mouth ultrasonic debridement	Full mouth ultrasonic debridement	Plaque and calculus are removed through full mouth ultrasonic debridement (FMUD) in all sites (both dental and implant).

Primary Outcome Measures

Name	Time	Method
Bleeding on probing	12 months	After probing dental and implant sites a dichotomic value (0/1) is assigned for each site. 0: not bleeding site; 1: bleeding site.

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth change	12 months	Change in probing pocket depth measured in millimeter through a periodontal probe.

Trial Locations

Locations (1)

AOUS; 🇮🇹 Siena, Italy